Wednesday, 20 Nov 2019

Biologic/Novel Rx

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20 May 2019 News EMA Restricts Tofacitinib Dosing
15 May 2019 News FDA Final Guidance on Interchangeability with Biosimilars
09 May 2019 Social Biologic Survival study from Japan- ANSWER study w/ 4466 courses in 2494 pts (2009-17). Efficacy Survival best for ABA, TCZ; worst for IFX & CZP. Toxicity Dropouts most in IFX & ADA, least ABA & CZP. Remission best w/ ETN & ABA, least w/ GLM, IFX.
08 May 2019 Social FDA has approved Ruzurgi (amifampridine) for Lambert-Eaton myasthenic syndrome in children 6-17 years. Drug works by blocking potassium channel efflux in nerve terminals, opening Ca2+ channels & increasing acetylcholine release
29 Apr 2019 Social FDA has approved Samsung-Bioepsis biosimilar version of etanercept - Eticovo (etanercept-ykro), approved in other countries under names Benepali and Brenzys. Approval based on 596 RA pt trial w/ 52 wk ACR20 of 80.8% and 81.5% (Enbrel arm)
24 Apr 2019 News Ustekinumab Effective in Behcet's Disease
23 Apr 2019 Social CORRONA study of 880 RA pts w/ hx of Solid cancer shows many on biologics following Dx. 42% were on biologics/tsDMARDs in the 12 mo before cancer. Post CA 31% were on same Rx, 5% switched biologics &10% started a biologic, the majority starting TNFi (54%).
18 Apr 2019 News Polypharmacy Blunts Responses and Ups the Safety Risks
11 Apr 2019 Social 117 pregnancies exposed to biologics were compared to 585 pregnancies not exposed to biologics; 6% of newborns had ≥1 congenital anomalies. No significant association between biologic exposure and congenital anomalies (HR 1.06; 95%CI 0.46-2.47) was seen.
04 Apr 2019 ACR Video A Video Collage of RheumNow Live 2019
01 Apr 2019 News RheumNowLive On Demand: Development & Use of JAK Inhibitors - Dr. John O'Shea
28 Mar 2019 News For RA With COPD, Abatacept is Safe
28 Mar 2019 News Ups and Downs with Abatacept
27 Mar 2019 Social Murine BM–derived macrophages or human monocytes treated w/ tofacitinib or selective JAK1, JAK3 inhibitors. Both TOFA & JAK1i but not JAK3i effectively inhibited STAT1 phosphorylation & IFN gamma production, suggesting affects on macrophage function.
26 Mar 2019 Social Boehringer Ingelheim announce s FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
18 Mar 2019 News No Rise in Cancer Risk with Actemra
13 Mar 2019 ACR Video QD Clinic - Secondary Loss of Efficacy
13 Mar 2019 News First Line IL-1 Inhibition in Systemic JIA
11 Mar 2019 ACR Video QD Clinic - Biologic Class Switching
25 Feb 2019 Social ERRATA: "How to Handle Latex Allergies and Biologics" - has been corrected to show that the Cimzia PFS DOES contain 7% of a plastic derived from natural rubber latex. Latex- sensitive patients should be advised to handle the needle shield with caution.