FDA Approves First Biologic Treatment for Polymyalgia Rheumatica

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FDA Approves First Biologic Treatment for Polymyalgia Rheumatica
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The interleukin-6 receptor antagonist sarilumab (Kevzara) will be indicated in adults who have had an inadequate response to corticosteroids or could not tolerate a corticosteroid taper.

The US Food and Drug Administration approved sarilumab today for the treatment of polymyalgia rheumatica in adults who have had an inadequate response to corticosteroids or could not tolerate a corticosteroid taper, joint developers

. The drug is the first and only FDA-approved biologic treatment for this inflammatory rheumatic disease. , an interleukin-6 receptor antagonist, in May 2017 for the treatment of moderate-to-severe active rheumatoid arthritis in adults who do not respond well or have an intolerance to disease-modifying antirheumatic drugs , like methotrexate.SAPHYR trial

in patients with corticosteroid-resistant, active PMR. In the randomized, double-blind, placebo-controlled study, 59 participants received 200 mg of sarilumab plus a 14-week taper of corticosteroid treatment and 58 participants received placebo every 2 weeks along with a 52-week taper of corticosteroid treatment.

After 1 year, 28% of sarilumab patients achieved sustained remission, compared with 10% of the placebo group (

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