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Articles tagged with "sirukumab"

Abatacept Approved for Psoriatic Arthritis in Adults; Sirukumab Approval Stalls

Michele B. Kaufman, PharmD, BCGP  |  September 17, 2017

Abatacept Approved for Adult PsA On June 30, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) to treat adults with active psoriatic arthritis (PsA).1 Abatacept is available as both an intravenous formulation and a subcutaneous injection.2 The approval was based on results of two randomized, double-blind, placebo-controlled trials, PsA-I and PsA-II, during which…

Sirukumab Approval Stalls

Michele B. Kaufman, PharmD, BCGP  |  August 15, 2017

Citing safety concerns, the FDA Arthritis Advisory Committee voted against recommending approval of sirukumab for treating adults with RA…

U.S. FDA Panel Votes Against Approval of Arthritis Drug Sirukumab

Toni Clarke  |  August 2, 2017

(Reuters)—The benefits of Johnson and Johnson’s experimental rheumatoid arthritis drug sirukumab do not outweigh the risks, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 12-1 that the drug should not be approved, citing safety concerns, including an imbalance in the number of deaths in patients taking sirukumab…

Sirukumab Promising for RA

Michele B. Kaufman, PharmD, BCGP  |  April 4, 2017

In a clinical trial, RA patients on sirukumab experienced decreased disease activity and improved physical function…

3 Clinical Trials Examine Sirukumab for RA; Plus TNF-α Combination & Monotherapies Are Compared for Treating PsA

Michele B. Kaufman, PharmD, BCGP  |  January 27, 2016

Three clinical trials are evaluating subcutaneous sirukumab for safety and efficacy in treating rheumatoid arthritis. And a study found no significant difference in persistence and remission for TNF-α monotherapy when compared with TNF-α plus conventional DMARD combination therapy for treating psoriatic arthritis…

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