000			03417nam a2200361 4500
001			ESSALUD
005			20260817155615.0
007			ta
008			t pe ||||| |||| 00| 0 spa d
040			_aBMG
041			_aspa
100			_aStone, John H. _eAutor _954096
245			_aPhase 3 trial of secukinumab in polymyalgia rheumatica
300			_apáginas: 637-647
520			_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.
650			_aALERGIA _97055
650			_aINMUNOLOGÍA _934121
650			_aENFERMEDAD AUTOINMUNE _953665
650			_aMEDICINA CLÍNICA _933681
650			_aGERIATRÍA _91852
650			_aREUMATOLOGÍA _97490
650			_aCÉLULAS T _954097
650			_aVASCULITIS _932232
700			_aButtgereit, Frank _954098
700			_aSaraux, Alain _954099
700			_aSchmidt, Wolfgang A. _954100
700			_aDejaco, Christian _954101
700			_aSpiera, Robert _954102
700			_aDasgupta, Bhaskar _954103
700			_aDrescher, Edit _954104
773	0		_022717 _922647 _dMassachusetts NEJM Group _oNEJM010 _tThe New England Journal of Medicine _wESSALUD _x0028-4793
942			_cARTICULOS _e2026-08-17 _zSQB
999			_c22824 _d22824