Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden—a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs

• Published in: Rheumatic & musculoskeletal diseases open 2019-01, Vol.5 (1), p.e000806
• Main Authors: Strand, Vibeke, de Vlam, Kurt, Covarrubias-Cobos, Jose A, Mease, Philip J, Gladman, Dafna D, Graham, Daniela, Wang, Cunshan, Cappelleri, Joseph C, Hendrikx, Thijs, Hsu, Ming-Ann
• Format: Article
• Language: English
• Subjects: Adalimumab - administration & dosage; Adalimumab - adverse effects; Adalimumab - therapeutic use; Adult; Antirheumatic Agents - administration & dosage; Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Arthritis, Psoriatic - diagnosis; Arthritis, Psoriatic - drug therapy; Clinical medicine; DMARDs (synthetic); Female; Humans; Immunotherapy; Male; Middle Aged; Monoclonal antibodies; outcomes research; Pain; patient perspective; Patient Reported Outcome Measures; Patients; Piperidines - administration & dosage; Piperidines - adverse effects; Piperidines - therapeutic use; Psoriasis; Psoriatic Arthritis; Pyrimidines - administration & dosage; Pyrimidines - adverse effects; Pyrimidines - therapeutic use; Pyrroles - administration & dosage; Pyrroles - adverse effects; Pyrroles - therapeutic use; Quality of life; Questionnaires; Rheumatoid arthritis; Studies; TNF inhibitors; treatment; Treatment Outcome; Tumor necrosis factor-TNF
• ISSN: 2056-5933; 2056-5933
• DOI: 10.1136/rmdopen-2018-000806

ObjectivesTofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). We evaluated patient-reported outcomes (PROs) in patients with PsA refractory to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) and tumour necrosis factor inhibitor-naïve in a 12-month, phase III randomised controlled trial (OPAL Broaden [NCT01877668]).MethodsPatients (N=422) received tofacitinib 5 mg or 10 mg twice daily, adalimumab 40 mg subcutaneously every 2 weeks or placebo advancing to tofacitinib 5 mg or 10 mg twice daily at month 3. Least squares mean changes from baseline and percentages of patients reporting improvements ≥minimum clinically important differences (MCID); and scores ≥normative values in: Patient Global Assessment of disease activity (PtGA), Pain, Patient Global Joint and Skin Assessment (PGJS), Short Form-36 Health Survey version 2 (SF-36v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), EuroQol 5-Dimensions-3-level questionnaire (EQ-5D-3L) and Ankylosing Spondylitis Quality of Life (ASQoL) were determined. Nominal p values were cited without multiple comparison adjustments.ResultsAt month 3, PtGA, Pain, PGJS, FACIT-Fatigue, EQ-5D-3L, ASQoL and SF-36v2 Physical Component Summary (PCS), physical functioning (PF), bodily pain (BP) and vitality domain scores exceeded placebo with both tofacitinib doses (p≤0.05); SF-36v2 social functioning with 5 mg twice daily (p≤0.05). Percentages reporting improvements ≥MCID in PtGA, Pain, PGJS, FACIT-Fatigue, ASQoL and SF-36v2 PCS, PF, BP and general health scores exceeded placebo with both tofacitinib doses (p≤0.05) and were similar with adalimumab.ConclusioncsDMARD-IR patients with active PsA reported statistically and clinically meaningful improvements in PROs with tofacitinib compared with placebo at Month 3.