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FDA Panel Rejects Tanezumab for Osteoarthritis

d Jack Cush, MD

A two day FDA review by the Drug Safety and Risk Management and Arthritis Advisory Committees has yielded a 19-1 vote against the approval of tanezumab, a nerve growth factor inhibitor, for use in osteoarthritis (OA).

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Future Therapeutics for Rheumatoid Arthritis and Lessons Learned - RNL2021 Highlights

d Kathryn H. Dao, M.D.

In case you missed it, RheumNow Live 2021 delivers what it promises: a good consistent program pack with high energy interactive learning.

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#RNL2021 https://t.co/bZdTYFdEn4

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News Feature: Safety of Paternal DMARD or Biologic Use https://t.co/9jCNJ9rHYF https://t.co/SIRPcPQxyB

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Retrospective study of 162 ANCA-Assoc Vasculitis patients (63% GPA, 37% MPA) - risk of serious infx was 7.5 per 100Pt-Yrs & was higher with cyclophosphamide that RTX induction. Risks for SIE:plasmapheresis dialysis & high BVAS in 1st year https://t.co/kAlz9aGQup

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Dr. Fleischmann vs. Dr. Matsumoto: get rid of MTX vs. get rid of biologic in RA remission. Both argue on sustained remission, risk for anti-drug antibodies, longterm safety. Dr. Buch’s perfect answer… “it depends on patient’s preference, cost.” #RNL2021 https://t.co/FBf2uoDx0B
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Why Pain Consults present Not Taking Pain Meds https://t.co/75YO027Oh6 https://t.co/rir90gM7qv

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UTSW Rheum Gr Rounds - Dr Saag Rules around genetic testing for HLA-B5801 @UTSWIMchief @KenSaag https://t.co/QCpKv0J2s2
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UTSW Rheum Gran Rounds - Dr. Ken Saag, Anakinra vs IA steroids @UTSWIMchief @KenSaag https://t.co/M2UCbyuJpb
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Dr. Ken Saag giving Rheum Grand Rounds at UT Southwestern. Data showing lower dose colchicine is safer than higher dose in acute gout @UTSWIMchief @KenSaag https://t.co/5KAn9SWlrU
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Biologic efficacy in 147 pts w/ eosinophilic granulomatosis with polyangiitis - compares RTX (63), mepolizumab (51) or omalizumab (31). Remission/partial rates were better in RTX (49%/24%) and MEPO (78%, 10%) vs OMA (15%/33%) https://t.co/ZsCFVnasIJ

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#RNL2021 https://t.co/8Cs4RZhBpW

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Uveitis is uncommonly caused drugs - especially : bisphosphonates, immune checkpoint inhibitors and antiviral drugs. https://t.co/hWO3QFcuMb

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News Feature: RECIPE Trial - Mycophenolate to Suppress Immunogenicity with Pegloticase in Gout https://t.co/3TkjwlrSEP https://t.co/GaS8cAJijq

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Retrospective review of 46 Rituximab treated ANCA-Assoc Vasculitis pts from 2 clinics (Mexico City, Lund) shows 24% had 18 severe infections (11.5/100 PY) - 72% within the 1st year. RTX was only independent SIE risk factor. 4 pts died, all from infection. https://t.co/8necVFP3AK

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#RNL2021 https://t.co/5eP9OejClB

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2020 Year in Review - Top Publications in SpA and Still’s Disease Sponsored by Novartis Medical Affairs Listen to medical experts discuss their latest insights in spondyloarthritis and Still’s disease. View Now: https://t.co/Kp2drDS1x3 https://t.co/avx5ZJ5DZb

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Adding RTX to leflunomide works but may at ACR50 level. 140 RA pts on LEF given RTX or PBO w/ ongoing LEF. Wk 16, RTX+LEF ACR50=32% (vs PBO 15%; P=0.02), but not wk 24 (27 vs 15%), yet ACR20 was signif. RTX had more SAEs (20 vs 2%) https://t.co/t6Z9m7P2Ur

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#RNL2021 https://t.co/5eP9Oe20X1

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#RNL2021 https://t.co/7IKrDE2Pt5

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