03423nam a2200361 4500001000800000005001700008007000300025008004100028040000800069041000800077100003400085245005900119300002300178520229400201650001802495650002602513650003302539650003102572650002202603650002602625650002302651650002202674700003102696700002602727700003402753700002902787700002802816700003102844700002802875773011002903942003103013999001703044ESSALUD20260817155615.0ta t pe ||||| |||| 00| 0 spa d aBMG aspa aStone, John H. eAutor954096 aPhase 3 trial of secukinumab in polymyalgia rheumatica apáginas: 637-647 aBackground: Polymyalgia rheumatica is a common inflammatory disease characterized by pain and stiffness in the shoulders and hips. Glucocorticoids are the first-line treatment, but relapses and glucocorticoid-related toxic effects are common, which underscores the need for effective alternatives. Secukinumab is a fully human monoclonal antibody that selectively inhibits interleukin-17A. Methods: We enrolled patients with recently relapsed polymyalgia rheumatica and randomly assigned them, in a 1:1:1 ratio, to receive secukinumab at a dose of 300 mg (SEC-300 group), secukinumab at a dose of 150 mg (SEC-150 group), or placebo for 52 weeks. Patients in all the groups also received prednisone on a tapering schedule for 24 weeks. The primary outcome was sustained remission at week 52, defined as remission (the absence of signs or symptoms attributable to polymyalgia rheumatica and no new diagnosis of giant-cell arteritis that warranted escape or rescue treatment) that was sustained from week 12 until week 52. The annual cumulative glucocorticoid dose was a secondary outcome. Safety was also assessed. Results: A total of 381 patients underwent randomization, and 127 were assigned to each group. At 52 weeks, sustained remission was observed in 41.2% (95% confidence interval [CI], 32.8 to 49.7) of the patients in the SEC-300 group, in 40.6% (95% CI, 32.2 to 49.0) of those in the SEC-150 group, and in 20.4% (95% CI, 13.6 to 27.2) of those in the placebo group (P<0.001 for the comparison of each secukinumab dose with placebo). The mean adjusted annual cumulative glucocorticoid dose was 1603.7 mg in the SEC-300 group, 1683.2 mg in the SEC-150 group, and 2093.0 mg in the placebo group. Serious adverse events occurred in 13.5% of the patients in the SEC-300 group, in 15.9% in the SEC-150 group, and in 14.2% in the placebo group. Nasopharyngitis, hypersensitivity reactions, urinary tract infections, fungal infections, and back pain were more common in the secukinumab groups than in the placebo group. Conclusions: Among patients with relapsed polymyalgia rheumatica, treatment with secukinumab plus a 24-week glucocorticoid taper resulted in a higher percentage of patients with remission and in lower cumulative glucocorticoid doses than a glucocorticoid taper alone. aALERGIA97055 aINMUNOLOGÍA 934121 aENFERMEDAD AUTOINMUNE953665 aMEDICINA CLÍNICA 933681 aGERIATRÍA91852 aREUMATOLOGÍA 97490 aCÉLULAS T954097 aVASCULITIS932232 aButtgereit, Frank 954098 aSaraux, Alain 954099 aSchmidt, Wolfgang A. 954100 aDejaco, Christian954101 aSpiera, Robert 954102 aDasgupta, Bhaskar 954103 aDrescher, Edit 9541040 022717922647dMassachusetts NEJM GroupoNEJM010tThe New England Journal of Medicine wESSALUDx0028-4793 cARTICULOSe2026-08-17zSQB c22824d22824