1. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)
- Author
-
Bernard Combe, Amy M. DeLozier, Joel M. Kremer, Li Xie, Josef S Smolen, Ivaylo Stoykov, Mark C. Genovese, Terence Rooney, Paul Bird, Juan Sanchez Burson, Douglas E Schlichting, Carol L. Gaich, [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 ), and Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS )
- Subjects
Baricitinib ,[SDV]Life Sciences [q-bio] ,Arthritis ,Efficiency ,DMARDs (biologic) ,Clinical-trials ,Logistic regression ,Severity of Illness Index ,Arthritis, Rheumatoid ,0302 clinical medicine ,Surveys and Questionnaires ,Immunology and Allergy ,030212 general & internal medicine ,Pain Measurement ,Sulfonamides ,Connective tissue disease ,3. Good health ,Outcomes research ,Rheumatoid arthritis ,DMARDs (synthetic) ,Adult ,medicine.medical_specialty ,Immunology ,Rheumatoid Arthritis ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,Patient perspective ,Abatacept ,03 medical and health sciences ,Young Adult ,Rheumatology ,Double-Blind Method ,Internal medicine ,Disease-activity ,medicine ,Improvement ,Humans ,Necrosis-factor inhibitors ,In patient ,Patient Reported Outcome Measures ,Protein Kinase Inhibitors ,030203 arthritis & rheumatology ,[ SDV ] Life Sciences [q-bio] ,business.industry ,Questionnaire ,Presenteeism ,Clinical and Epidemiological Research ,medicine.disease ,Methotrexate ,Purines ,Tofacitinib ,Physical therapy ,Quality of Life ,Azetidines ,Pyrazoles ,Quality-of-life ,Therapy ,business - Abstract
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
- Published
- 2017