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Best of 2021: Tofacitinib Safety Concerns

Dec 29, 2021 8:55 am

Dr. Jack Cush reviews and discusses the news and journal reports from the past week on

  1. Metanalysis of 3 cross-sectional & 2 case-control studies shows that the risk of developing #RA is elevated in patients with Crohns colitis (RR = 3.14; 95% CI: 2.46–4.01) and ulcerative colitis (RR = 2.29; 95% CI: 1.76–2.97)
  2. Vagal Nerve Stimulation in Rheumatoid Arthritis Lancet Rheumatology has reported the results of a proof of concept trial, wherein vagal nerve stimulation was shown to ameliorate rheumatoid arthritis (RA) disease activity.
  3. More on Vagal Nerve Stimulation in RA ( The device used was an earbud, designed to deli)ver electrical pulse sequences to target the cholinergic anti-inflammatory pathway. They called this neural input methodology, e-mmunotherapy
  4. One-Third Rheumatoid Risk from Lifestyle Analysis of the NHANES data suggests that 1/3 of the risk of developing RA in the USA is attributable smoking, obesity and alcohol intake.
  5. Abbvie has released data from KEEPsAKE-1 and KEEPsAKE-2 studies (1407 pts) showing Risankizumab (IL--23 inhibitor) is effective in Psoriatic arthritis; RIS Rx pts achieved ACR20 of 57% and 51% at week 24 (vs PBO 34% and 27%; p<0.001)
  6. Metanalysis of 24 studies finds pregnant women, w/ inflammatory disease, exposed to biologics had NO increased risk of congenital anomalies (adj OR 1.18; 0.88, 1.57), but had increased preterm births (OR 1.61; 1.37, 1.89) & low birth weight (OR 1.68)
  7. French study of 782 men (50-85 years) with DISH found DISH was associated with increased vertebral fractures (OR 2.89; 95% CI, 1.15-7.28; P <.05), but Nonvertebral fractures were not associated with DISH (HR 0.72; 0.33-1.56).
  8. Multiple intraarticular steroid injxs NO better than placebo. Analysis of 6 RCTs show no diff in pain than PBO (−0.47, 95% CI −0.62, 0.31). 14 RCTs + 2 Observ. studies show IA steroids may cause mor cartilage loss or risk of joint replacement (HR 2.54)
  9. Low Persistence of Biologics in Psoriatic Arthritis 
  10. OpenSAFELY analysis shows that NSAIDs safe w/ COVID. Study 1: 1/2 million NSAID users vs ~2 mill non-users found no difference in COVID-19 death (HR 0.96); Study 2: 1.7 million RA/OA pts, 10% on NSAIDs had a lower risk of COVID-19 death (HR 0.78)
  11. Adverse Events with Anti-malarials during the COVID Pandemic
  12. Hydroxychloroquine Fails to Prevent COVID-19
  13. Cardiac and Cancer Signals Tofacitinib Safety Alert from FDA 

Editor's note: This podcast appeared February 5, 2021 and is being published again today as part of RheumNow's Best of 2021. 

The author has no conflicts of interest to disclose related to this subject

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