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Future Big BiTEs (6.28.2024)

Dr. Jack Cush reviews the news, journal articles and regulatory announcements from the past week on

  1. FDA has approved sarilumab (Kevzara) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing 63 kg (138.891 lbs) or greater.
  2. Abbvie announced upadacitinib (Rinvoq) is approved for use in polyarticular JIA and Psoriatic Arthritis (in children 2 years of age and older who have had an inadequate response or intolerance to 1 or more tumor necrosis factor (TNF) blockers)
  3. FDA has approved risankizumab (Skyrizi) to treat adults with moderately to severely active ulcerative colitis (UC), making it the IL-23 inhibitor approved for UC. Approval is based on two large phase 3 clinical trials (COMMAND, INSPIRE)
  4. JAMA: 3 prospective cohort studies in USA show that multivitamin use by 390 124 healthy adults did not alter mortality risk (HR, 1.04; 95% CI, 1.02-1.07)
  5. Moonlake has announced its phase 3 program to develop Sonelokimab (M1095) a dual inhibitor of IL-17A & IL-17F for use in Psoriatic arthritis. IZAR-1 & IZAR-2 Ph 3 DBPCT will enroll 1,500 adults w/ active PsA, w/ ACR 50 endpoint at Week 16
  6. Lit. cohort analysis of >330K #AS shows higher risk of cancer (RR=1.16: 1.07–1.26); w/ higher risk in Asia, but not Europe. Increased CA risk for : bone (RR 3.41), thyroid(1.76), myeloma (1.74), leukemia (1.52), kidney (1.45), prostate (1.43), NHL (1.42)
  7. Systematic review of Autoimmune Dz (AID) & myelodysplastic syndrome (MDS) finds AIDs found in 17.5% of MDS pts. With AID, MDS mortality rates ranged 15.3-67%. Why this relationship exists is unclear.
  8. EUSTAr study of 4431 systemic sclerosis (SSc) pts - anti-SSA antibodies are detected in 15% of SSc-patients and represent an independent risk factor for the presence of lung fibrosis (OR 1.24) & more severe lung involvement. #EULA2024 OP0013
  9. Finnish study of 331 systemic sclerosis (SSc) pts found that SSc is the major cause of death in diffuse & limited SSc. Among 91 deaths, the 5 & 10 year survival was 88% and 80%. Most common cause death was SSc (n=35) & ILD (13).
  10. Study of 2,974 SLE pts taking hydroxychloroquine (HCQ) found 584 w/ ≥1 hospitalization for SLE. Taking Lower doses of HCQ (≤5 mg/kg/d) or <400 mg/d were assoc w/ increased hospitalizations for active SLE (adjusted OR 4.20 & aOR 3.39, respectively)
  11. JAK inhibitors have been used as adjunctive therapy to reduce inflammation arising with checkpoint inhibitor use in cancer (Hodgkins, Lung CA), using itacitinib w/ pembrolizumab or ruxolitinib & nivolumab improved trial outcomes
  12. BiTEs (Bispecific T cell engagers) kill B cells by engaging T cells. IV blinatumomab (CD19xCD3 BiTE) rx of 6 refractory RA pts, led to B & T cell depletion, rapid decline Dz activity, synovitis, autoAbs & was safe, w/ brief temp & ^CrP w/ 1st rx
  13. No Risk of Interstitial Lung Disease with Methotrexate Use  
  14. Protective Benefits of SGLT2 Inhibitors and Lupus Nephritis  


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