Contributors: [Smolen, Josef S.] Med Univ Vienna, Vienna, Austria; [Smolen, Josef S.] Hietzing Hosp, Vienna, Austria; [Kremer, Joel M.] Albany Med Coll, Albany, NY 12208 USA; [Gaich, Carol L.] Eli Lilly & Co, Indianapolis, IN 46285 USA; [DeLozier, Amy M.] Eli Lilly & Co, Indianapolis, IN 46285 USA; [Schlichting, Douglas E.] Eli Lilly & Co, Indianapolis, IN 46285 USA; [Xie, Li] Eli Lilly & Co, Indianapolis, IN 46285 USA; [Stoykov, Ivaylo] Eli Lilly & Co, Indianapolis, IN 46285 USA; [Rooney, Terence] Eli Lilly & Co, Indianapolis, IN 46285 USA; [Bird, Paul] Univ New South Wales, Sydney, NSW, Australia; [Sanchez Burson, Juan Miguel] Valme Univ Hosp, Div Rheumatol, Seville, Spain; [Sanchez Burson, Juan Miguel] Valme Univ Hosp, Div Ophthalmol, Seville, Spain; [Sanchez Burson, Juan Miguel] Valme Univ Hosp, Div Immunol, Seville, Spain; [Genovese, Mark C.] Stanford Univ, Med Ctr, Palo Alto, CA 94304 USA; [Combe, Bernard] Univ Montpellier, Lapeyronie Hosp, Montpellier, France; Eli Lilly and Company; Incyte Corporation; Medizinische Universität Wien = Medical University of Vienna; Albany Medical College; University of New South Wales [Sydney] (UNSW); Valme University Hospital; Stanford University Medical Center; Institut de Génétique Moléculaire de Montpellier (IGMM); Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM); Albany medical college; University of New South Wales [Sydney] ( UNSW ); Institut de Génétique Moléculaire de Montpellier ( IGMM ); Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS )
نبذة مختصرة : Objectives To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to >= 1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).Methods In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.Results 527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI = 1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).Methods In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.Results 527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI = 3.56; p
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