Stop Counting Bugs (10.4.2024)
Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com.This week’s rants include the microbiome, PsA treatment choices and fishing for P-values in research.
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FDA has approved Otulfi (ustekinumab-aauz), a ustekinumab biosimilar for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Otulfi ismade by Fresenius Kabi and Formycon https://t.co/p2h9X0C16W https://t.co/YD0uJSEbaq
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CORRECTION!! UCB announced the LAUNCH of a new phase 3b BE BOLD trial - this study has no report results as yet. It WILL BE a H2H RCTcomparing bimekizumab & rizankizumab in adult #PsA pts using an ACR50 primary endpoint. Yesterday we incorrectly reported this as a completed… https://t.co/apa6VMuQTi https://t.co/BTpwo6ww7W
Dr. John Cush @RheumNow( View Tweet )
UCB released topline results of a phase 3b H2H "BE BOLD" RCT of bimekizumab (anti-IL17) vs rizankizumab (anti-IL23) in 550 active adult #PsA pts - at wk 16 inhibition of IL-17A/F was superior to IL-23 using the ACR50 primary endpoint. https://t.co/aWnHYefS2C https://t.co/2Vft5fouFv
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Bimekizumab FDA Approved for Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis and Ankylosing Spondylitis
UCB announced today that the U.S. Food and Drug Administration (FDA) has approved bimekizumab-bkzx (Bimzelx) for the treatment of 3 chronic inflammatory… https://t.co/aITAeYuJxv https://t.co/tAPFfshPSs
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In utero exposure to upadacitinib review w/ 128 maternal exposures & known outcomes; 80 from RCTs & 48 Postmarketing Pregs. From RCTs - 54-46% live births, 24-38% spont. abortions, 21-15% elective Ab, 1-2% ectopics from RCTs & Postmarketing. No evidence of teratogenicity… https://t.co/s3VJspI59V https://t.co/tV48sKyF8x
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Pain Relief with JAK Inhibitors or Anti-TNFs ?
Targeted drugs for rheumatoid arthritis (RA) are not created equal when it comes to pain relief, a retrospective study from Sweden indicated, although the differences appeared to be modest.
https://t.co/oIgNxBF518 https://t.co/L9g9MJQbQx
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Adult (133,216) vs Pediatric (955) pts on JAKi - analysis of FAERS shows both @ incr risk for infections & GI AEs. Pediatric pts had more blood and lymphatic disorders, while adults had more CNS and MSK/CTD disorders https://t.co/SKjzANYPSq https://t.co/S6JPYuvSlf
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Which One is the Loneliest Number (9.27.2024)
Dr. Jack Cush reviews the regulatory approvals, announcements, guidelines and interesting journal articles from the past week on RheumNow.com. When not to use muscle relaxants, how frequent is loneliness in RA/PsA/SpA, and when to refer patients with Still's disease.
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UCB & Biogen report positive topline results of Phase 3 RCT of Dapirolizumab Pegol (anti-CD40L) in #SLE & will launch a 2nd Ph 3 RCT in 2024. Phase 3 PHOENYCS GO study was 48 wks of DAP vs PBO in mod-severe SLE w/ BILAG improvement by wk 48 https://t.co/G1DJf31T6t https://t.co/DgpTObIXrB
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Genentech announced top line results of the REGENCY Phase III study of obinutuzumab (Gazyva) in lupus nephritis. 271 LN (class III or IV; +/- V) taking MMF & steroids were given placebo or OBIN for 76 wks. OBIN was superior @ complete renal resp at 76 wks… https://t.co/Um9du7fgxE https://t.co/RRWumnbTuy
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INVIGORATE-2 Study - IV Secukinumab in Active Psoriatic Arthritis
The INVIGORATE-2 trial reports that intravenous (IV) secukinumab (SEC) is both effective and safe in patients with active psoriatic arthritis (PsA), demonstrating improvements on par with subcutaneous SEC.… https://t.co/I1TVGIHByN https://t.co/WwSRQxrKAE
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EULAR/PReS Still's Disease Management Recommendations
Since 2022, EULAR and the Paediatric Rheumatology European Society (PReS) have been working to establish clinical practice guidelines for the diagnostics and management of systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still’s disease (AOSD).
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I Can't Treat Ugly (9.20.2024)
Dr. Jack Cush reviews the news, journal articles and a new FDA approval for EGPA, this week on the Podcast.
https://t.co/mSI16Ug4iR https://t.co/arCx6yo5p6
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FDA decision explained on why they modified its rule on #Biosimilar interchangeability. Approved 15 yrs ago, now there are 50 Biosimilars in USA. Switching (interchangeability) studies are no longer needed based on the FDA experience over last 8 years. https://t.co/vpmgdVeDwz https://t.co/UAWnFQxugl
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Fasenra (benralizumab, an anti-IL-5 mAb) has been FDA approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA); approval based on MANDARA trial - H2H noninferior to mepolizumab at remission https://t.co/5tAPolUItK https://t.co/VHCNjACThw
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FOREMOST: Apremilast in Early Oligoarticular Psoriatic Arthritis
A controlled trial has shown that apremilast is effective in patients with early, oligoarticular psoriatic arthritis (PsA).
https://t.co/i2w4RbGd5f https://t.co/5PD6pYB5vm
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Metanalysis of JAKi in ILD (7 studies, 183 pts) showed increases in FVC (2 %), DLCO (3.1%) & improved Thoracic HRCT of 11%; only 5% had worsening of their ILD. Risk of ILD w/ JAKi was low ( 0.20/1000 PY) w rates similar to abatacept & rituximab https://t.co/UDJ1ZvtGhh https://t.co/WTQS67yDyl
Links:
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Pipeline drugs and trials intended for Interstitial Lung Disease - including studies with nintedinib, Efzofitimod, BI 1015550, AD-214, Abatacept, ATYR1923, Pirfenidone inhalation, RO-0220912, Lung stem cells...Riociguat, Treprostinil and more https://t.co/fpMjjubPVx https://t.co/ketFP0N9jk
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Yes you can space out Guselkumab injx in controlled Psoriasis. Phase 3b RCT of 149 GUS pts w/ PASI <4 were cont on GUS q8 wks or spaced to q16wks. Noninferiority was shown w/ maintenance of "super-responders" in > 90% w/ both https://t.co/4Y9quetoJn https://t.co/zP9ywFKpvY
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I Can't Treat Ugly (9.20.2024)
Dr. Jack Cush reviews the news, journal articles and a new FDA approval for EGPA, this week on the Podcast.
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Voclosporin and Steroids in Lupus Nephritis
Dr. Jack Cush reports on abstract OP0059 presented at Eular 2024 in Vienna, Austria.
https://t.co/4CilABzEjm https://t.co/hgyDqG1fPR
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So You've Got RA and Want to Get Pregnant?
Dr. David Liew reviews abstract POS0436 presented at Eular 2024 in Vienna, Austria.
https://t.co/vG9l7kOReq https://t.co/xhumOCisOM
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Chinese study of 62 Systemic JIA pts Rx w/ IV Tocilizumab (34 12 mg/kg; 28 8 mg/kg). Wk12 87% responded (JIA ACR 30w/ no fever); Week 52 results were similar. No deaths or macrophage activation syndrome occurred. https://t.co/qGgMCt597x https://t.co/lFDxAgDHfW
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BSR Guidelines for Systemic Sclerosis Management
The British Society for Rheumatology (BSR) has updated its 2015 guidelines for the management of patients with sytemic sclerosis (SSc) based on published evidence, systematic literature review and expert opinion.
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