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
Objectives Tofacitinib 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...
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BMJ Publishing Group
2019-05-01
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| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/5/1/e000806.full |
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| author | Philip J Mease Dafna D Gladman Vibeke Strand Kurt de Vlam Jose A Covarrubias-Cobos Daniela Graham Cunshan Wang Joseph C Cappelleri Thijs Hendrikx Ming-Ann Hsu |
| author_facet | Philip J Mease Dafna D Gladman Vibeke Strand Kurt de Vlam Jose A Covarrubias-Cobos Daniela Graham Cunshan Wang Joseph C Cappelleri Thijs Hendrikx Ming-Ann Hsu |
| author_sort | Philip J Mease |
| collection | DOAJ |
| description | Objectives Tofacitinib 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]).Methods Patients (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.Results At 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.Conclusion csDMARD-IR patients with active PsA reported statistically and clinically meaningful improvements in PROs with tofacitinib compared with placebo at Month 3. |
| format | Article |
| id | doaj-art-3ce70b78fcd64432b61b5c5d39a99ba1 |
| institution | Matheson Library |
| issn | 2056-5933 |
| language | English |
| publishDate | 2019-05-01 |
| publisher | BMJ Publishing Group |
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| series | RMD Open |
| spelling | doaj-art-3ce70b78fcd64432b61b5c5d39a99ba12025-07-15T12:10:12ZengBMJ Publishing GroupRMD Open2056-59332019-05-015110.1136/rmdopen-2018-000806Tofacitinib 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 drugsPhilip J Mease0Dafna D Gladman1Vibeke Strand2Kurt de Vlam3Jose A Covarrubias-Cobos4Daniela Graham5Cunshan Wang6Joseph C Cappelleri7Thijs Hendrikx8Ming-Ann Hsu94 Swedish Medical Center and University of Washington, Seattle, Washington, USA8 Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada1 Division of Immunology/Rheumatology, Stanford University, Palo Alto, California, USA2 Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium3 Unidad Reumatologica Las Americas S.C.P., Mérida, Yucatán, Mexico6 Pfizer Inc, Groton, Connecticut, USA6 Pfizer Inc, Groton, Connecticut, USA6 Pfizer Inc, Groton, Connecticut, USA7 Pfizer Inc, Collegeville, Pennsylvania, USA6 Pfizer Inc, Groton, Connecticut, USAObjectives Tofacitinib 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]).Methods Patients (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.Results At 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.Conclusion csDMARD-IR patients with active PsA reported statistically and clinically meaningful improvements in PROs with tofacitinib compared with placebo at Month 3.https://rmdopen.bmj.com/content/5/1/e000806.full |
| spellingShingle | Philip J Mease Dafna D Gladman Vibeke Strand Kurt de Vlam Jose A Covarrubias-Cobos Daniela Graham Cunshan Wang Joseph C Cappelleri Thijs Hendrikx Ming-Ann Hsu 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 RMD Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://rmdopen.bmj.com/content/5/1/e000806.full |
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