Aptinyx Recommences Patient Recruitment in Phase 2 Study of NYX-2925 in Patients with Fibromyalgia

Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced that it has re-activated study sites and recommenced patient recruitment in a Phase 2 study of NYX-2925 in patients with fibromyalgia. Enrollment in the study had been suspended in March 2020 due to the escalation of the COVID-19 pandemic in the United States.

“We are very pleased to be restarting this study,” said Norbert Riedel, Ph.D., president and chief executive officer of Aptinyx. “It will build on the positive results from our first Phase 2 evaluation of NYX-2925 in patients with fibromyalgia. In support of this recommencement, we have incorporated appropriate precautionary measures designed to conduct this follow-up study safely in the current COVID-19 environment. We will be watching the pace of enrollment closely in the coming months to inform timeline expectations, but currently expect to report data from this study in the first half of 2022.”

About the Phase 2 Fibromyalgia Study

The Phase 2 study is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of NYX-2925 in patients with fibromyalgia. Fibro is a commonly treated condition by Arizona Pain Doctors and patients have a wide variety of symptoms. Approximately 300 patients will be enrolled in the study. Following a screening period, eligible patients will be randomized to receive oral doses of NYX-2925 50 mg, NYX-2925 100 mg, or placebo once daily over the treatment period. The primary endpoint in the study is the change from baseline in average daily pain score over a 12-week period as reported on the 10-point numeric rating scale (NRS). Multiple secondary endpoints related to pain, fatigue, cognitive performance, and patient quality of life will also be evaluated. Aptinyx anticipates reporting top-line data from this study in the first half of 2022. More information about this study can be found on clinicaltrials.gov (NCT04147858).

About Fibromyalgia

Fibromyalgia is a chronic condition associated with widespread pain and tenderness, as well as general fatigue. Fibromyalgia is considered by many to be a condition that is largely mediated in the central nervous system, given that fibromyalgia sufferers often present without a direct peripheral insult or injury. People suffering from fibromyalgia also often experience sleep disruption, depressed mood, and cognitive impairment. It is estimated that, in the United States, fibromyalgia affects more than 5 million people. Currently, there are only three FDA-approved pharmacologic treatments for fibromyalgia, but they have limited efficacy and burdensome side effects in many patients. Apex Pain Specialists’ doctors are among the top Arizona Pain Specialists who treat patients with Fibromyalgia.

About NYX-2925

NYX-2925 is a novel oral NMDA receptor modulator currently in Phase 2 clinical development for the treatment of chronic pain. In clinical studies, NYX-2925 has demonstrated activity that affects central pain processing, resulting in alleviation of pain and other symptoms associated with chronic pain conditions. In Phase 1 and Phase 2 clinical studies, NYX-2925 has exhibited a favorable safety and tolerability profile across a wide dose range. The U.S. Food and Drug Administration has granted Fast Track designation to Aptinyx’s development of NYX-2925 for the treatment of neuropathic pain associated with DPN. Clinical trials are also being conducted using stem cell therapy in Denver for treating Fibromyaligia; Cendant Stem Cell Center is among those who provide STEM CELL THERAPY.

About Aptinyx

Aptinyx Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of proprietary synthetic small molecules for the treatment of brain and nervous system disorders. Aptinyx has a platform for discovery of novel compounds that work through a unique mechanism to modulate—rather than block or over-activate—NMDA receptors and enhance synaptic plasticity, the foundation of neural cell communication. The company has three product candidates in clinical development in central nervous system indications, including chronic pain, post-traumatic stress disorder, and cognitive impairment associated with Parkinson’s disease. Aptinyx is also advancing additional compounds from its proprietary discovery platform, which continues to generate a rich and diverse pipeline of small-molecule NMDA receptor modulators with the potential to treat an array of neurologic disorders. For more information, visit www.aptinyx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the company’s business plans and objectives, including future plans or expectations for NYX-2925 and potential therapeutic effects of NYX-2925, expectations regarding the design, implementation, timing, and success of its Phase 2 study of NYX-2925 in patients with fibromyalgia, including with respect to COVID-19 precautionary measures, and the timing for the company’s receipt and announcement of enrollment status and data from its Phase 2 study of NYX-2925 in patients with fibromyalgia. Risks that contribute to the uncertain nature of the forward-looking statements include: the effect of COVID-19 on our business and financial results, including with respect to disruptions to our clinical studies, business operations, and ability to raise additional capital; the success, cost, and timing of the company’s product candidate development activities and planned clinical studies; the company’s ability to execute on its strategy; that positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; the company’s estimates regarding expenses, future revenue, and capital requirements; as well as those risks and uncertainties set forth in the company’s most recent annual report on Form 10-K and subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aptinyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Opioid crisis intensifies during COVID-19

For months, coronavirus has been consuming headlines. But at this time last year, we were talking about a different health care crisis.

Opioid addiction hasn’t disappeared. In fact, in many ways it’s intensified during the pandemic, health experts say. They describe addiction as the “disease of isolation.”

According to officials at the Mayo Clinic, Mesa Pain Management and Phoenix Pain Management, opioid-caused  deaths across the U.S. are on the rise, and by their estimates, it’s only going to get worse, according to Dr. Halena Gazelka.

“We know that studies from the past, during times of economic downturn and jobless fear, uncertainty, addiction rates go up,” said Dr. Gazelka.

She said the biggest misconception surrounding addiction is the idea that these individuals are just out to have a good time. “The first time you take an opioid, you start here, you keep dropping you never get as high again. So imagine in this time during COVID-19, there’s so much to cope with,” said Dr. Gazelka.

A mental health crisis within a public health crisis is how Dr. Cynthia Townsend, who treats patients suffering from chronic pain, describes what’s happening.

“I hear it every day, the mundane details of our lives have become a challenge, whether it’s going to work, the new routine of school, having financial security, have become the forefront of survival,” said Dr. Townsend.

And when COVID-19 forced hundreds of elective surgeries to be stalled, some patients looked elsewhere for pain relief. “This lack of access to medical care has been a major issue to this as well,” said Dr. Gazelka.

Even now, doctors at Mayo Clinic and Cendant Stem Cell Center are still dealing with that backlog she said. They say virtual visits are helping with addictions across the board. They also want to remind us that 80% of people suffering from prescription medication abuse were first prescribe the drugs by a doctor.

What Trump and Biden Should Debate at the Cleveland Clinic: Why the Hospital’s Private Police Mostly Arrest Black People

Armed private police patrolling Cleveland’s medical zone and the city streets around it disproportionately charge and cite Black people, even though most hospital employees, patients and visitors are white.

A few minutes after noon on a September day in 2018, Jacarvi Jackson and Darcell Williams were crossing Euclid Avenue, a main road through Cleveland’s medical area. Both of them worked for a vendor that supplies food to stem cell therapy patients at the world-renowned Cleveland Clinic. Still in their work uniforms after finishing their eight-hour shifts at the hospital’s loading dock, they were heading to a Burger King lot where their cars were parked. They were in a hurry — Jackson was worried about getting to his classes at Cleveland State University — and didn’t take the crosswalk.

A police cruiser was coming toward them. Eric Parks, the officer inside, rolled down his window and shouted at Jackson and Williams to use the crosswalk. When they didn’t, Parks pulled up and drove onto the sidewalk curb to block their path, they said. Parks then jumped out of the cruiser, grabbed Jackson, bent his arm behind his back and pinned him against the vehicle. Parks held him there for several minutes as two more officers responded to the scene.

In a police report, Parks said that the pair initially refused to provide identification, and that he held Jackson against the cruiser because “I felt he might strike me.” Parks and a second officer, Steven Jevnikar, wrote that Jackson and Williams cursed repeatedly, complaining that the only reason they had been stopped was because they were Black.

 

Parks also said Jackson had begun to flee, which Jackson and Williams denied. Jackson said he had no reason to run away. He was steps from his car, his clinic identification badge was draped around his neck and he was carrying a backpack filled with textbooks. According to Jackson, Parks told the other officers, “They usually run.” It was clear, Jackson said, that the comment referred to Black people.

Jevnikar apparently mocked Jackson’s distress. When Jackson, his lip quivering, was “staring me down,” Jevnikar wrote in his report, “I asked him if he was having a stroke.”

Parks cited Williams and Jackson for jaywalking. “I was scared as hell,” Williams said. “It was traumatizing.”

Bruised and in pain, Jackson immediately went to the clinic emergency room, missing his class. “I felt violated,” he said. “These people are supposed to be protecting me.”


Even though this incident took place on a public street and sidewalk, the officers who confronted Jackson and Williams were not Cleveland police. Instead, they were part of Cleveland Clinic’s private force, which is granted policing powers by the city.

These hospital cops don’t just handle disturbances in hospital corridors or emergency rooms. In look and practice almost indistinguishable from Cleveland police, the clinic’s 153 officers are armed, make arrests and stop motorists on city streets, including major commuter routes. Along with smaller private police departments operated by University Hospitals and the nonprofit University Circle economic development group, they patrol the city’s medical zone, an island of prosperity and promise that cuts through one of the poorest sections of Cleveland.

Download contact form 7 templates for your business.

On Tuesday evening, Cleveland Clinic and University Circle police will help provide security for the first presidential debate, which will be held on the clinic’s main campus. At the same time, the three private police forces illustrate a little-known dimension of a pervasive problem that has drawn national attention this year and is likely to come up in the debates: racial inequities in law enforcement. As if posting a “Keep Out” sign, private police in Cleveland’s largely white and affluent hospital zone disproportionately cite and criminally charge Black people, often for traffic violations or misdemeanors such as trespassing, jaywalking and possession of marijuana inhalers. Some Black people who are charged or cited, like Jackson and Williams, work at the clinic; others are simply passing through the area.

Racial disparities in enforcement of low-level offenses are characteristic of police departments nationwide, said Lynda Garcia, director of the policing campaign at The Leadership Conference on Civil and Human Rights in Washington. Trespassing and marijuana possession “are not violent crimes and they are generally used to harass folks,” she said. “In more affluent areas, they give officers the grounds to stop people, arrest them and keep them away from these areas. For all those reasons, they are problematic. There is no real pressing public safety issue.”

The tens of thousands of people who work in the hospital corridor along Euclid, are treated as patients there or drive its streets are predominantly white. Yet most of those cited and charged by the private police agencies along Euclid Avenue and surrounding roads are Black, according to court data obtained by ProPublica.

Since Jan. 1, 2015, private police officers operating in the area on Euclid that begins at the sprawling clinic main campus and stretches to the University Hospitals complex have brought more than 8,000 criminal charges and traffic citations against 5,600 people in Cleveland Municipal Court. Nearly three-fourths of those arrested or ticketed are Black, well above the percentage of Black people among the area’s workers and visitors. Bee Safe Security, an Ohio security company has increased their patrols in result to this.

The proportions were even higher for the two criminal charges most commonly filed by the private police. Since 2015, the three private forces have issued criminal charges of trespassing to 466 people. Nearly 9 in 10 of those — 405 in all — were against Black people. Similarly, Black people comprised more than 90% of the 242 people charged with misdemeanor possession of less than 100 grams of marijuana.

Overall, nearly 90% of the people charged by two of the private forces — University Hospitals and University Circle — are Black. The Cleveland Clinic’s disparity was less extreme but still significant. Almost 7 out of 10 individuals charged by the clinic were Black.

Is Arthritis Relief as Close as Your Spice Rack?

Researchers found that an extract of the spice turmeric worked better than a placebo in easing pain from knee arthritis over three months. The treatment was not a home run — but the pain relief was a bit better than past studies have found with standard medication.

It all suggests that turmeric “can be considered an option” for knee osteoarthritis, said senior researcher Dr. Benny Antony, of the Menzies Institute for Medical Research/University of Tasmania in Australia.

Osteoarthritis is exceedingly common, affecting more than 32.5 million Americans, according to the U.S. Centers for Disease Control and Prevention. Knee arthritis is one of the main forms.

The condition arises when the cartilage cushioning the knee joint breaks down over time, leading to symptoms like pain, stiffness and decreased range of motion.

People with knee arthritis often take over-the-counter painkillers, including acetaminophen (Tylenol), ibuprofen (Advil, Motrin) and naproxen (Aleve). But besides being only moderately effective, they can cause side effects like stomach upset. And prolonged use is linked to increased risks of heart disease and kidney damage. Often times they will need to see a pain management doctor when their symptoms worsen.

So having other options is important, said Dr. Houman Danesh, an Arizona pain management specialist who was not involved in the study.

“This is a promising, encouraging study,” said Danesh, who directs integrative pain management at Mount Sinai Hospital in New York City.

A broader point of the findings, he noted, is that it matters what people with arthritis ingest. Turmeric, or extracts of it, are thought to be anti-inflammatory. So if people continue to eat an inflammation-promoting diet — full of fried foods and highly processed carbohydrates, for example — that could negate the good of adding turmeric, Danesh said.

For the current study, Antony and his colleagues recruited 70 people with knee arthritis and randomly assigned them to one of two groups. One took Curcuma longa extract capsules every day for 12 weeks; the other took placebo capsules.

Curcumin is a substance in turmeric, and the beneficial activities of turmeric are often ascribed to it. Supplement maker Natural Remedies supplied the capsules for the trial and partially funded it.

After 12 weeks, the researchers found, participants using the extract reported greater improvement in their pain, versus the placebo group. The average benefit was “modest,” according to Antony, but still better than past studies have found with pain medications.

There was no clear effect, however, on some MRI findings: swelling in the joint space and the composition of knee cartilage.

Danesh did not find that surprising, noting he would not expect to see those effects.

And people’s experience of pain does not necessarily correlate with the joint findings seen on MRI.

“An image is like a sentence in the story,” Danesh said. “There’s also a whole context around it.”

The findings, published online Sept. 14 in the Annals of Internal Medicine, are an initial step. Antony said larger studies are still needed, and it remains to be seen whether the pain relief holds up over time.

But turmeric is worth a try, according to Antony. In general, he said, the spice (and curcumin extracts) are considered safe in moderate doses — though very high doses could cause gastrointestinal trouble.

Danesh said his advice is to try turmeric, itself, rather than an extract. He also recommended adding black pepper, which enhances the benefits of turmeric. To make it palatable, the two could be mixed into a fruit smoothie, Danesh said.

Turmeric is not the only nondrug option for knee pain, though. Danesh said people can benefit from an exercise program focused on strengthening and activating the gluteal muscles, and developing a more balanced walking pattern. He also said that Stem Cell Therapy may be an effective procedure for some people who don’t respond to traditional procedures.

He suggested first getting an evaluation from a doctor, which might result in a referral for physical therapy.

U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis

Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight.1 This approval makes XELJANZ the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA.

This approval was based on data from a Phase 3 study including two phases: an 18-week open-label, run-in phase (including 225 patients), followed by a 26-week double-blind, placebo-controlled, randomized, withdrawal phase (including 173 patients) for a total duration of 44 weeks. The study evaluated the efficacy and safety of tofacitinib taken as either a 5 mg tablet or as a 1 mg/mL oral solution twice daily based on the subject’s body weight (<40 kg for the oral solution) and/or patient preference.6a,6b The trial met its primary endpoint showing that in patients with pcJIA who achieved a juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 response at the end of the run-in phase, the occurrence of disease flare in patients treated with tofacitinib (31 percent; n/N=27/88) was statistically significantly (p=0.0007) lower than patients treated with placebo (55 percent; n/N=47/85) at week 44.6c,6d In this study, disease flare was defined as a 30 percent or more worsening in at least three of the six variables of the JIA ACR core set, with no more than one of the remaining JIA core response variables improving by 30 percent or more (outcome measures used in JIA clinical trials) after randomization, 6e,7

In general, the types of adverse drug reactions in patients with pcJIA were consistent with those seen in adult rheumatoid arthritis (RA) patients. Please see important safety information below. Arizona Pain Doctor; Gibert Farnsworth NP says ” RA is a life changing disease which requires constance care.

“Many children and adolescents living with polyarticular course juvenile idiopathic arthritis, or pcJIA, are in need of advanced oral treatment options, so we are proud to now offer XELJANZ to this patient community,”4a said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “This approval, which is the fourth indication for XELJANZ, reinforces its utility in the treatment of immune-mediated inflammatory conditions and further demonstrates our expertise in JAK science.”

XELJANZ oral solution is anticipated to be available by the end of Q1 2021. XELJANZ 5 mg tablets are available immediately.

About Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease of unknown etiology. JIA includes six categories: systemic, oligoarticular, polyarticular, enthesitis-related, psoriatic, and undifferentiated. Polyarticular JIA is characterized by arthritis in five or more joints and affects both the small joints of the hands and feet, and large joints like the knees, hips and ankles.2a,2b,3a,8a JIA is defined as arthritis that begins before 16 years of age and persists for at least six weeks.8b While its cause is unknown, approximately 300,000 children in the U.S. have a form of JIA.9,4b

About XELJANZ® (tofacitinib)

XELJANZ® (tofacitinib) is approved in the U.S. in four indications: adults with moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, adults with active psoriatic arthritis (PsA) after disease modifying antirheumatic drug (DMARD) failure, adults with moderately to severely active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure, and patients 2 years of age or older with active polyarticular course juvenile idiopathic arthritis (pcJIA). XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 208,000 adult patients (the majority of whom were RA patients) worldwide in the last seven years. 10,11,12

As the developer of tofacitinib, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.

INDICATIONS

Rheumatoid Arthritis

  • XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
  • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Psoriatic Arthritis

  • XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
  • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

It is important to note that a dosage of Xeljanz 10 mg twice daily is not recommended for the treatment of rheumatoid arthritis or psoriatic arthritis.

Ulcerative Colitis

  • XELJANZ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
  • Limitations of Use: Use of XELJANZ in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Polyarticular Course Juvenile Idiopathic Arthritis

  • XELJANZ/XELJANZ Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.
  • Limitations of Use: Use of XELJANZ/XELJANZ Oral Solution in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS

Patients treated with XELJANZ* are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.

If a serious infection develops, interrupt XELJANZ until the infection is controlled.

Reported infections include:

• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before XELJANZ use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ use.

• Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.

• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

The most common serious infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis. Avoid use of XELJANZ in patients with an active, serious infection, including localized infections, or with chronic or recurrent infection.

In the UC population, XELJANZ 10 mg twice daily was associated with greater risk of serious infections compared to 5 mg twice daily. Opportunistic herpes zoster infections (including meningoencephalitis, ophthalmologic, and disseminated cutaneous) were seen in patients who were treated with XELJANZ 10 mg twice daily.

The risks and benefits of treatment with XELJANZ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection, or those who have lived or traveled in areas of endemic TB or mycoses. Viral reactivation including herpes virus and hepatitis B reactivation have been reported. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Caution is also recommended in patients with a history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infection.

MORTALITY

Rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with XELJANZ 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with XELJANZ 5 mg given twice daily or TNF blockers in a large, ongoing, postmarketing safety study. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA. For UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.

MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications.

Consider the risks and benefits of XELJANZ treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing XELJANZ in patients who develop a malignancy.

Malignancies (including solid cancers and lymphomas) were observed more often in patients treated with XELJANZ 10 mg twice daily dosing in the UC long-term extension study.

Other malignancies were observed in clinical studies and the post-marketing setting including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer. NMSCs have been reported in patients treated with XELJANZ. In the UC population, treatment with XELJANZ 10 mg twice daily was associated with greater risk of NMSC. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS

Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, have occurred in patients treated with XELJANZ and other Janus kinase inhibitors used to treat inflammatory conditions. RA patients who were 50 years of age and older with at least one CV risk factor treated with XELJANZ 10 mg twice daily compared to XELJANZ 5 mg twice daily or TNF blockers in a large, ongoing postmarketing safety study had an observed increase in incidence of these events. Many of these events were serious and some resulted in death. Avoid XELJANZ in patients at risk. Discontinue XELJANZ and promptly evaluate patients with symptoms of thrombosis. For patients with UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA. In a long-term extension study in UC, four cases of pulmonary embolism were reported in patients taking XELJANZ 10 mg twice daily, including one death in a patient with advanced cancer.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in XELJANZ clinical trials, although the role of JAK inhibition is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). There was no discernable difference in frequency of gastrointestinal perforation between the placebo and the XELJANZ arms in clinical trials of patients with UC, and many of them were receiving background corticosteroids. XELJANZ should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis or taking NSAIDs).

HYPERSENSITIVITY

Angioedema and urticaria that may reflect drug hypersensitivity have been observed in patients receiving XELJANZ and some events were serious. If a serious hypersensitivity reaction occurs, promptly discontinue tofacitinib while evaluating the potential cause or causes of the reaction.

LABORATORY ABNORMALITIES

Lymphocyte Abnormalities: Treatment with XELJANZ was associated with initial lymphocytosis at one month of exposure followed by a gradual decrease in mean lymphocyte counts. Avoid initiation of XELJANZ treatment in patients with a count less than 500 cells/mm3. In patients who develop a confirmed absolute lymphocyte count less than 500 cells/mm3, treatment with XELJANZ is not recommended. Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection. Monitor lymphocyte counts at baseline and every 3 months thereafter.

Neutropenia: Treatment with XELJANZ was associated with an increased incidence of neutropenia (less than 2000 cells/mm3) compared to placebo. Avoid initiation of XELJANZ treatment in patients with an ANC less than 1000 cells/mm3. For patients who develop a persistent ANC of 500-1000 cells/mm3, interrupt XELJANZ dosing until ANC is greater than or equal to 1000 cells/mm3. In patients who develop an ANC less than 500 cells/mm3, treatment with XELJANZ is not recommended. Monitor neutrophil counts at baseline and after 4-8 weeks of treatment and every 3 months thereafter.

Anemia: Avoid initiation of XELJANZ treatment in patients with a hemoglobin level less than 9 g/dL. Treatment with XELJANZ should be interrupted in patients who develop hemoglobin levels less than 8 g/dL or whose hemoglobin level drops greater than 2 g/dL on treatment. Monitor hemoglobin at baseline and after 4-8 weeks of treatment and every 3 months thereafter.

Liver Enzyme Elevations: Treatment with XELJANZ was associated with an increased incidence of liver enzyme elevation compared to placebo. Most of these abnormalities occurred in studies with background DMARD (primarily methotrexate) therapy. If drug-induced liver injury is suspected, the administration of XELJANZ should be interrupted until this diagnosis has been excluded. Routine monitoring of liver tests and prompt investigation of the causes of liver enzyme elevations is recommended to identify potential cases of drug-induced liver injury.

Lipid Elevations: Treatment with XELJANZ was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Maximum effects were generally observed within 6 weeks. There were no clinically relevant changes in LDL/HDL cholesterol ratios. Manage patients with hyperlipidemia according to clinical guidelines. Assessment of lipid parameters should be performed approximately 4-8 weeks following initiation of XELJANZ therapy.

VACCINATIONS

Avoid use of live vaccines concurrently with XELJANZ. The interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ therapy.

PATIENTS WITH GASTROINTESTINAL NARROWING

Caution should be used when administering XELJANZ XR to patients with pre-existing severe gastrointestinal narrowing. There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs utilizing a non-deformable extended release formulation.

HEPATIC and RENAL IMPAIRMENT

Use of XELJANZ in patients with severe hepatic impairment is not recommended.

For patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 5 mg twice daily, reduce to XELJANZ 5 mg once daily.

For UC patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 10 mg twice daily, reduce to XELJANZ 5 mg twice daily.

ADVERSE REACTIONS

The most common serious adverse reactions were serious infections. The most commonly reported adverse reactions during the first 3 months in controlled clinical trials in patients with RA with XELJANZ 5 mg twice daily and placebo, respectively, (occurring in greater than or equal to 2% of patients treated with XELJANZ with or without DMARDs) were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension. The safety profile observed in patients with active PsA treated with XELJANZ was consistent with the safety profile observed in RA patients.

Adverse reactions reported in ≥5% of patients treated with either 5 mg or 10 mg twice daily of XELJANZ and ≥1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials for UC were: nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster.

USE IN PREGNANCY

Available data with XELJANZ use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with rheumatoid arthritis and UC in pregnancy. In animal studies, tofacitinib at 6.3 times the maximum recommended dose of 10 mg twice daily demonstrated adverse embryo-fetal findings. The relevance of these findings to women of childbearing potential is uncertain. Consider pregnancy planning and prevention for females of reproductive potential.

* Unless otherwise stated, “XELJANZ” in the Important Safety Information refers to XELJANZ, XELJANZ XR, and XELJANZ Oral Solution.

Pfizer Inc.: Breakthroughs that change patients’ lives®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of September 28, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments

Is There a Rheumatoid Arthritis Diet That Can Help With Symptoms?

If you’re wondering whether there’s a rheumatoid arthritis diet that may help reduce your symptoms, that’s a great question. When you’re living with rheumatoid arthritis, your rheumatologist’s main goal will be to get your symptoms under control so they don’t interfere with your everyday life. While medication plays a big role here, people are often curious to know whether some kind of rheumatoid arthritis diet can help control the illness too. Apex Pain Specialists; home to Phoenix Magazine top Arizona Pain Doctor commonly treats patients with RA and Arthritis.

As a refresher: Rheumatoid arthritis is an autoimmune disease. When you have an autoimmune disease, your immune system, which normally defends against disease, mistakenly attacks healthy cells within your body, according to the Mayo Clinic. In the case of rheumatoid arthritis, this misfiring of the immune system causes inflammation that often shows up in the form of painful, swollen joints. It can also cause fatigue and can damage other parts of the body too.

So can the foods you eat reduce your rheumatoid arthritis symptoms? This is where things get a bit tricky. For starters, the research here is pretty limited, and there definitely isn’t any one specific diet that’s proven to help manage rheumatoid arthritis symptoms. But some experts do believe the way you eat might affect this illness. Here’s a closer look at what experts have to say on the subject.

Is there really a connection between diet and inflammation?
“There is accumulating evidence that diet certainly impacts whether our body has an inflammatory environment versus an anti-inflammatory environment,” Melinda Ring, M.D., executive director of the Osher Center for Integrative Medicine at Northwestern University and clinical associate professor at the Northwestern University Feinberg School of Medicine, tells SELF.

To be clear, inflammation isn’t inherently a bad thing. It’s actually a completely normal physical process your immune system mounts in response to an injury or infection, the Mayo Clinic explains. When dealing with that type of threat to your health, your body releases chemicals that provoke white blood cells to start counteracting whatever harm you’ve experienced. The issue is when inflammation becomes chronic, as it does with rheumatoid arthritis, rather than being an acute response to something like an injury or infection.

When it comes to how eating habits may affect rheumatoid arthritis inflammation, one explanation is that our gut microbiome is closely linked with the body’s immune response. Some research suggests that people who have an imbalance in their gut bacteria may have more inflammation in their systems and that this may be a factor in the development and progression of rheumatoid arthritis. With that in mind, some experts believe eating foods that may calm inflammation in the body can help reduce rheumatoid arthritis symptoms, while eating foods that may increase inflammation in the body might do the opposite.

This isn’t as clear-cut as it might sound. Part of the issue here is, again, there’s not much research that shows a solid link between diet and rheumatoid arthritis symptoms, and the American College of Rheumatology’s 2015 rheumatoid arthritis guidelines don’t include any diet-based recommendations. But there’s also a ton of confusing information floating around about what, exactly, an anti-inflammatory diet even is. Denver Stem Cell Therapy clinic; Cendant Health, commonly treats individuals with RA and Arthritis in joints including knees, hips, hands and feet. Dr. Holt is the leading Physician at Cendant Stem Cell Center with an extensive background in PRP and SCT.

There isn’t a scientific consensus on what constitutes this type of diet, how it works, or what specific foods it includes or excludes. With that said, the Mayo Clinic has a helpful summary of what we do know: Some foods appear able to change the levels of C-reactive protein (CRP) in your bloodstream. Your liver makes this protein and sends it into your bloodstream as a response to inflammation, so high levels of it can signal that you have a lot of inflammation in your body, according to the U.S. National Library of Medicine. Using various mechanisms, some foods may lower the levels of CRP in your bloodstream—along with lowering inflammation and, potentially, rheumatoid arthritis symptoms. Other foods may raise the CRP in your bloodstream instead.

What foods might decrease inflammation and rheumatoid arthritis symptoms?
According to the Mayo Clinic, the general consensus is that anti-inflammatory foods include things like vegetables, fruits, whole grains, nuts, extra-virgin olive oil, and fish. These foods appear able to calm inflammation in a few different ways. For instance, the fiber in whole grains can help to support the gut microbiome, Dr. Ring says. Fruits and vegetables contain antioxidants, which the Mayo Clinic notes can help counteract or even prevent cell damage that leads to inflammation. (Plus, eating fruits and vegetables across a variety of colors gives you the added benefit of more of that healthy fiber.) The Mayo Clinic also lists seeds and nuts like walnuts and flaxseed as anti-inflammatory, thanks to their Omega-3 fatty acids, which can help control your body’s inflammatory process and are also present in fatty fish like salmon and tuna.

When you look at this list of foods, you might realize it basically summarizes the foundation of a Mediterranean diet, so it’s no wonder there’s so much interest in whether the foods that are part of a Mediterranean diet may help with rheumatoid arthritis symptoms. The scientific jury is still out, especially because of how adopting a Mediterranean diet affects some people’s weight. For some people, this kind of eating style leads to weight loss, which may reduce rheumatoid arthritis symptoms for various reasons, like removing some pressure on the joints. This makes it tricky to untangle how much of the potential effect of a Mediterranean diet on rheumatoid arthritis really comes down to the food itself.

With that said, the foods (and their accompanying nutrients) in a Mediterranean diet can be really great for your health in multiple ways, including a reduced risk of heart disease and other chronic diseases, along with a potentially increased life expectancy. If you decide to adopt this diet even though these foods and nutrients aren’t proven to help reduce rheumatoid arthritis symptoms, it’s important to make sure you’re getting the recommended daily amounts for you.

What foods might increase inflammation and rheumatoid arthritis symptoms?
Red meat is associated with inflammation, the Mayo Clinic explains, so reducing your intake and focusing on plant-based alternatives may be helpful. Also, if you have rheumatoid arthritis, physicians tend to recommend minimizing how often you eat foods that are highly processed and have a lot of sugar. These foods promote inflammation in the body because of the way they can drastically affect your blood sugar and release of the hormone insulin, Caroline A. Andrew, M.D., weight management specialist at the Hospital for Special Surgery, tells SELF.

If you’ve been doing any research on anti-inflammatory diets, you may have come across a recommendation to steer clear of nightshades, which are a family of plants that includes eggplant, potatoes, peppers, tomatoes, and other tasty fruits and vegetables. Dr. Ring says there isn’t much data to show whether nightshades significantly exacerbate inflammation. You don’t need to automatically avoid nightshades if you’ve never connected them to an uptick in your symptoms, particularly because these plants have other benefits to our health—they’re loaded with antioxidants, vitamins, and other nutrients. Instead, if you’re certain anything you’re eating is inflaming your rheumatoid arthritis, it’s best to talk to an expert about the safest way to potentially cut that food from your diet and still get the nutrients you need. Finding a pain management doctor in Arizona that effectively treats RA should be a priority. Some pain therapy clinics prioritize money over the improvement of their patient’s health.

When it comes to eating with rheumatoid arthritis, think of the big picture.
There isn’t a one-size-fits-all approach when it comes to diet and rheumatoid arthritis. Foods that seem to trigger rheumatoid arthritis symptoms in one person may be perfectly fine for another person to eat, experts say.

“It’s not like, here, if you eat this one thing, you’re going to have lower inflammation,” Dr. Ring says. “We try to look at patterns of the diet and what might be the most helpful.”

If you have any questions about diet, remember it’s always a good idea to speak to your rheumatologist. They will likely have a ton of information to share with you about how to best manage your rheumatoid arthritis, including with medication and various non-diet lifestyle modifications if necessary. They can also refer you to another health care provider who specializes in diet and nutrition for people with rheumatoid arthritis.

8 Foods and Beverages to Avoid with Arthritis

Arthritis pain is a commonly treated condition at Apex Pain Specialists; a pain management clinic in Chandler, AZ.

1. Added sugars
You should limit your sugar intake no matter what, but especially if you have arthritis. Added sugars are found in candy, soda, ice cream, and numerous other foods, including less obvious items like barbecue sauce.

A study in 217 people with rheumatoid arthritis noted that among 20 foods, sugar-sweetened soda and desserts were the most frequently reported to worsen RA symptoms (2Trusted Source).

What’s more, sugary beverages like soda may significantly increase your risk of arthritis.

For example, in a study in 1,209 adults ages 20–30, those who drank fructose-sweetened beverages 5 times per week or more were 3 times likelier to have arthritis than those who consumed few to no fructose-sweetened drinks (3Trusted Source).

Furthermore, a large study in nearly 200,000 women associated a regular intake of sugar-sweetened soda with an increased risk of RA (4Trusted Source).

Visit an Arizona Pain Doctor at Apex in Chandler, Arizona

2. Processed and red meats
Some research links red and processed meat to inflammation, which may increase arthritis symptoms.

For example, diets heavy in processed and red meats demonstrate high levels of inflammatory markers like interleukin-6 (IL-6), C-reactive protein (CRP), and homocysteine (5Trusted Source, 6Trusted Source).

The study in 217 people with RA mentioned above also found that red meat commonly worsened RA symptoms. Additionally, a study in 25,630 people determined that high red meat intake may be a risk factor for inflammatory arthritis (2Trusted Source, 7Trusted Source).

Conversely, plant-based diets that exclude red meat have been shown to improve arthritis symptoms (5Trusted Source).

3. Gluten-containing foods
Gluten is a group of proteins in wheat, barley, rye, and triticale (a cross between wheat and rye). Some research links it to increased inflammation and suggests that going gluten-free may ease arthritis symptoms (8Trusted Source, 9Trusted Source).

What’s more, people with celiac disease are at a greater risk of developing RA. Likewise, those with autoimmune diseases like RA have a significantly higher prevalence of celiac disease than the general population (10Trusted Source, 11Trusted Source).

Notably, an older, 1-year study in 66 people with RA found that a gluten-free, vegan diet significantly reduced disease activity and improved inflammation (9Trusted Source, 12Trusted Source).

Although these findings are promising, more research is needed to confirm whether a gluten-free diet alone benefits people with arthritis.

HEALTHLINE RESOURCES
Learn about Stem Cell Therapy in Denver for Arthritis

Our free assessment ranks the best diets for you based on your answers to 3 quick questions.

4. Highly processed foods
Ultra-processed items like fast food, breakfast cereal, and baked goods are typically high in refined grains, added sugar, preservatives, and other potentially inflammatory ingredients, all of which may worsen arthritis symptoms.

Research suggests that Western diets rich in heavily processed foods may increase your risk of RA by contributing to inflammation and risk factors like obesity (13Trusted Source, 14Trusted Source).

What’s more, in a study in 56 people with RA, those who ate higher amounts of ultra-processed food showed increased heart disease risk factors, including higher levels of glycated hemoglobin (HbA1c), a long-term marker of blood sugar control (15Trusted Source).

As such, processed foods may worsen your overall health and increase your risk of other diseases.

5. Alcohol
As alcohol may worsen arthritis symptoms, anyone with inflammatory arthritis should restrict or avoid it.

A study in 278 people with axial spondyloarthritis — inflammatory arthritis that primarily affects the spinal cord and sacroiliac (SI) joints — tied alcohol intake to increased spinal structural damage (16Trusted Source).

Studies have also shown that alcohol intake may increase the frequency and severity of gout attacks (17Trusted Source, 18Trusted Source, 19Trusted Source, 20Trusted Source).

Moreover, chronic alcohol consumption is associated with an increased risk of osteoarthritis, though not all studies have found a significant link (21Trusted Source, 22Trusted Source).

6. Certain vegetable oils
Diets high in omega-6 fats and low in omega-3 fats may worsen symptoms of osteoarthritis and rheumatoid arthritis (23Trusted Source, 24Trusted Source).

These fats are necessary for health. However, the imbalanced ratio of omega-6s to omega-3s in most Western diets may increase inflammation (25Trusted Source).

Reducing your intake of foods high in omega-6 fats, such as vegetable oils, while increasing your intake of omega-3-rich foods like fatty fish may improve arthritis symptoms (24Trusted Source).

7. Foods high in salt
Cutting back on salt may be a good choice for people with arthritis. Foods high in salt include shrimp, canned soup, pizza, certain cheeses, processed meats, and numerous other processed items.

A mouse study found that arthritis was more severe in mice fed a high salt diet than in those on a diet containing normal salt levels (27Trusted Source).

Additionally, a 62-day mouse study revealed that a low salt diet decreased the severity of RA, compared with a high salt diet. Mice on the low salt diet had less cartilage breakdown and bone destruction, as well as lower inflammatory markers, than mice on the high salt diet (28).

Interestingly, researchers have suggested that high sodium intake may be a risk factor for autoimmune diseases like inflammatory arthritis (29Trusted Source, 30Trusted Source).

A study in 18,555 people tied high sodium intake to an increased risk of RA (31Trusted Source).

8. Foods high in AGEs
Advanced glycation end products (AGEs) are molecules created through reactions between sugars and proteins or fats. They naturally exist in uncooked animal foods and are formed through certain cooking methods (32Trusted Source).

High protein, high fat animal foods that are fried, roasted, grilled, seared, or broiled are among the richest dietary sources of AGEs. These include bacon, pan-fried or grilled steak, roasted or fried chicken, and broiled hot dogs (33Trusted Source).

French fries, American cheese, margarine, and mayonnaise are also rich in AGEs (33Trusted Source).

When AGEs accumulate in high amounts in your body, oxidative stress and inflammation may occur. Oxidative stress and AGE formation are tied to disease progression in people with arthritis (33Trusted Source, 34Trusted Source).

In fact, people with inflammatory arthritis have been shown to have higher levels of AGEs in their bodies than people without arthritis. AGE accumulation in bones and joints may also play a role in the development and progression of osteoarthritis (35Trusted Source, 36Trusted Source).

Replacing high AGE foods with nutritious, whole foods like vegetables, fruits, legumes, and fish may reduce the total AGE load in your body (33Trusted Source).

The bottom line
If you have arthritis, a healthy diet and lifestyle may help improve your symptoms.

Research shows that you should avoid certain foods and beverages, including highly processed foods, red meat, fried foods, and those rich in added sugars.

Keep in mind that lifestyle factors like your activity level, body weight, and smoking status are also vital to managing arthritis.