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Pharma/Regulatory

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Risk vs. Benefit Lessons from the ORAL Surveillance Study

Jan 27, 2022

In an editorial in the current edition of the NEJM, Dr. Jasvinder Singh comments on the Oral Surveillance trial (Ytterberg et al.), a 4-year randomized, open-label, noninferiority, postauthorization, safety end-point trial, in high risk active rheumatoid arthritis patients over age 50 years.

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MMWR: Booster Vaccine Efficacy in Immunosuppressed Patients

CDC/MMWR
Jan 27, 2022

For adults aged ≥18 years who received 2 doses of an mRNA COVID-19 vaccine, a third dose increased vaccine effectiveness (prevention of hospitalization) among adults without (82% to 97%) and with immunocompromising conditions (69% to 88%), with near similar efficacy.



The ACIP

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Physical Therapy is More Cost-Effective than Intraarticular Steroids in Knee OA

Jan 26, 2022

A randomized trial compared the incremental cost-effectiveness of physical therapy and intra-articular glucocorticoid (IA GC) injection as initial treatment for knee osteoarthritis showed that physical therapy gained more quality-adjusted life-years compared with those receiving

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Allopurinol Safety in CKD Patients

Jan 26, 2022

A study in the Annals of Internal Medicine reports chronic kidney disease (CKD) patients can be safely treated with allopurinol without an increased risk of mortality.



In this population-based data, neither allopurinol initiation, nor achieving target SU level with

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How Preventable Is Rheumatoid Arthritis?

MedPage Today
Jan 25, 2022

Women who made at least four healthy lifestyle choices saw their risk of developing rheumatoid arthritis reduced significantly, an analysis of Nurses' Health Study (NHS) data found.



Adopting such habits as moderate drinking, never smoking, regular exercise, and a good diet was

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FDA Approves Skyrizi for Active Psoriatic Arthritis

Jan 24, 2022

On Friday, the U.S. Food and Drug Administration (FDA) approved risankizumab-rzaa (Skyrizi) for the treatment of adults with active psoriatic arthritis (PsA), with similar dosing in plaque psoriasis - a single 150mg subcutaneous injection four times a year after two starter doses (at weeks 0

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3rd Vaccine Dose May Benefit ANCA-Associated Vasculitis Patients

Jan 20, 2022

ARD has publish a prospective, multicenter, observational study of vaccination outcomes in antineutrophil cytoplasmic antibodies associated vasculitis (AAV) patients, showing that AAV patients may not be adequately protected after standard two-dose COVID-19 vaccination, but that a

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Herpes Zoster Vaccination in Immunocompromised Adults

Jan 20, 2022

The CDC's Advisory Committee on Immunization Practices (ACIP) recently recommended and approved two doses of the recombinant zoster vaccine (RZV, AKA Shingrix) for prevention of herpes zoster and complications in immunodeficient or immunosuppressed adults aged ≥19 years.

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Weak Vaccine Responses in ANCA-Associated Vasculitis Patients

MedPage Today
Jan 18, 2022

Patients with ANCA-associated vasculitis (AAV) did not mount durable antibody responses to the SARS-CoV-2 Delta variant after the standard two-dose regimen of the Pfizer-BioNTech vaccine -- and for those taking rituximab (Rituxan) as maintenance therapy, even a third dose wasn't much help.

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BE MOBILE 1 Study - Bimekizumab in Non-Radiographic Axial Spondyloarthritis

Jan 18, 2022

Today, UCB announced top-line interim analysis results from their Phase 3 "BE MOBILE 1" study, that demonstrated the efficacy of bimekizumab, a dual IL-17A and F inhibitor, in adults with active non-radiographic axial spondyloarthritis (nr-axSpA).

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Fracture Risk with Osteoporosis Drug Holidays

Jan 17, 2022

While bisphosphonate drug holidays are recommended, there are few comparative studies. Annals of Internal Medicine describes a propensity matched comparison study of risedronate and alendronate, showing that, compared to alendronate, risedronate drug holidays were associated with a small

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Why Are Physicians Silent About Outrageous Drug Prices?

MedPage Today
Jan 14, 2022

This article was written by Dr. Milton Packer, who wonders why physicians are struggling to get their priorities straight.

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The Overpricing of Drugs (1.14.2022)

Jan 14, 2022

Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com. This week we discuss amputations, a $57 billion RA market, an FDA approved drug for Cat arthritis and drug that works in Sjogren's.




  1. Study 126 rheumatic disease (RMD) patients showed that

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Hold Myophenolate or Not with COVID-19 Vaccination?

Jan 13, 2022

While the American College of Rheumatology recommends holding mycophenolate (MMF) in rheumatic and musculoskeletal diseases patients (RMD) receiving COVID-19 vaccines, there is limited data on such an approach. A recent cohort study of RMD patients showed that holding MMF yielded higher antibody

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COVAX Registry: Safety of COVID-19 Vaccines in Rheum Patients

Jan 13, 2022

The EULAR Coronavirus Vaccine (COVAX) physician-reported registry has shown that the use of COVID-19 vaccines in people with inflammatory/autoimmune rheumatic and musculoskeletal disease (I-RMD) is effective, safe, and well tolerated.



Rheumatic and autoimmune patients were not

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KEEPSaKe-1 Trial in Psoriatic Arthritis - IL-23 Inhibition is Effective

Jan 12, 2022

The results of the KEEPSaKE-1 study in psoriatic arthritis (PsA) has been published and shows that risankizumab (RIZ), an IL-23 inhibitor, showed significant clinical improvements when given to active PsA patients who failed or were intolerant to ≥1 csDMARD.

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What Can JIA Patients Expect 18 Years In?

MedPage Today
Jan 12, 2022

Follow-up in a Scandinavian cohort of juvenile idiopathic arthritis (JIA) patients that began in 1997-2000 revealed a number of surprises, a new study indicated.



More than two-thirds of patients were using no drug therapies at year 18, even though only about half were in remission and

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Biologic Treatment of Primary Sjogrens with Ianalumab

Jan 11, 2022

Clinical trials generally fail in Sjögren's syndrome; but now a study shows that a biologic B cell inhibitor, ianalumab, met its primary endpoint with a dose-related decrease in disease activity (measured by ESSDAI) at week 24.



This was a phase II, dose-finding trial, aimed to assess

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BEAT LUPUS - Belimumab after Rituximab in SLE

Jan 11, 2022

A recent trial published in Annals of Internal Medicine analyzed the effects of B-cell depletion (rituximab) followed by B-cell suppression (belimumab) and showed effective lowering of anti-dsDNA titers and and fewer severe flare in patients with systemic lupus erythematosus (SLE).

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COVID-19 in Pregnant Rheumatic Women

Jan 10, 2022

The Global Rheumatology Alliance (GRA) has studied the outcomes of women with rheumatic disease who were pregnant at the time of infection with coronavirus disease 2019 (COVID-19).



The GRA database of rheumatic patients also includes information about pregnancy; further obstetric

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2021 Rheumatology Year in Review

Jan 08, 2022

Our top 10 list of advances, game-changers, worries and those better medical practices that evolved during 2021.

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COVID Breakthrough Infections with Arthritis and HIV

MedPage Today
Jan 06, 2022

Among immunocompromised individuals vaccinated against COVID-19, solid organ transplant recipients as well as those with HIV and rheumatoid arthritis (RA) were significantly more likely to experience breakthrough infections versus people without immune dysfunction, a retrospective study found

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Clinical Practice Guidelines for Multisystem Inflammatory Syndrome in Children

Jan 05, 2022

Multisystem inflammatory syndrome in children (MIS-C) is new and serious complication of COVID-19 that preferentially affects adolescents. A review of proposed management guidelines is compiled in this report, suggesting a unified approach to therapeutic management of MIS-C.

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Spesolimab, an IL-36 Blocker, in Pustular Psoriasis

Jan 03, 2022

The NEJM has published the results of a phase 2 randomized trial showing that the use of an interleukin-36 receptor inhibitor, spesolimab, resulted in rapid improvement of generalized pustular psoriasis (at 1 week), but that adverse events and infections were of concern with 12 weeks of

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Safety of COVID-19 Vaccines in Rheumatic Patients

Jan 03, 2022

Since the introduction of COVID-19 vaccines in January 2021, rheumatologists have fully advocated the protective benefits of their use - yet many have rarely noted flares and reactive side effects worrisome to patients.  Now a multinational study shows that the use of COVID vaccination in

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