Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond
Objectives Tofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). Patient-reported outcomes (PROs) were evaluated in patients with PsA with inadequate responses to tumour necrosis factor inhibitors (TNFi-IR) in a 6-month, phase III randomised controlled trial (OPAL...
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BMJ Publishing Group
2019-06-01
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| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/5/1/e000808.full |
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| author | Philip J Mease Dafna D Gladman Vibeke Strand Kurt de Vlam Jose A Covarrubias-Cobos Joseph C Cappelleri Thijs Hendrikx Ming-Ann Hsu Linda Chen Elizabeth Kudlacz Joseph Wu |
| author_facet | Philip J Mease Dafna D Gladman Vibeke Strand Kurt de Vlam Jose A Covarrubias-Cobos Joseph C Cappelleri Thijs Hendrikx Ming-Ann Hsu Linda Chen Elizabeth Kudlacz Joseph Wu |
| author_sort | Philip J Mease |
| collection | DOAJ |
| description | Objectives Tofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). Patient-reported outcomes (PROs) were evaluated in patients with PsA with inadequate responses to tumour necrosis factor inhibitors (TNFi-IR) in a 6-month, phase III randomised controlled trial (OPAL Beyond [NCT01882439]).Methods Patients (N=394) received tofacitinib 5 or 10 mg twice daily or placebo (advancing to tofacitinib 5 or 10 mg twice daily at month 3). Least squares mean changes from baseline and percentages of patients reporting improvements ≥minimum clinically important differences and scores ≥normative values were determined 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 (EQ-5D-3L), EQ-VAS and Ankylosing Spondylitis Quality of Life (ASQoL). Nominal p values are without multiple comparison adjustments.Results At month 3, PtGA, Pain, PGJS, SF-36v2 Physical Component Summary (PCS), physical functioning (PF), bodily pain (BP), vitality and social functioning (SF) domains, FACIT-Fatigue Total score, EQ-5D-3L pain/discomfort, EQ-VAS and ASQoL scores exceeded placebo with both tofacitinib doses (role physical [RP] with 10 mg twice daily only; p≤0.05). Patients reporting improvements ≥MCID (%) in PtGA, PGJS, Pain, ASQoL and SF-36v2 PCS, PF, RP, BP, SF (both tofacitinib doses) exceeded placebo (p≤0.05).Conclusion TNFi-IR patients with PsA receiving tofacitinib reported statistically and clinically meaningful improvements in PROs versus placebo over 3 months, which were maintained to month 6. Despite lower baseline scores, these improvements were similar to the csDMARD-IR TNFi-naive OPAL Broaden trial. |
| format | Article |
| id | doaj-art-b588dc5320de4e5ba0b282bb4ec3da0c |
| institution | Kabale University |
| issn | 2056-5933 |
| language | English |
| publishDate | 2019-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | RMD Open |
| spelling | doaj-art-b588dc5320de4e5ba0b282bb4ec3da0c2025-08-20T03:25:22ZengBMJ Publishing GroupRMD Open2056-59332019-06-015110.1136/rmdopen-2018-000808Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL BeyondPhilip J Mease0Dafna D Gladman1Vibeke Strand2Kurt de Vlam3Jose A Covarrubias-Cobos4Joseph C Cappelleri5Thijs Hendrikx6Ming-Ann Hsu7Linda Chen8Elizabeth Kudlacz9Joseph Wu104 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, USA7 Pfizer Inc, Collegeville, Pennsylvania, USA6 Pfizer Inc, Groton, Connecticut, USA6 Pfizer Inc, New York, New York, USA7 Pfizer Inc, Groton, Connecticut, USA7 Pfizer Inc, Groton, Connecticut, USAObjectives Tofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). Patient-reported outcomes (PROs) were evaluated in patients with PsA with inadequate responses to tumour necrosis factor inhibitors (TNFi-IR) in a 6-month, phase III randomised controlled trial (OPAL Beyond [NCT01882439]).Methods Patients (N=394) received tofacitinib 5 or 10 mg twice daily or placebo (advancing to tofacitinib 5 or 10 mg twice daily at month 3). Least squares mean changes from baseline and percentages of patients reporting improvements ≥minimum clinically important differences and scores ≥normative values were determined 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 (EQ-5D-3L), EQ-VAS and Ankylosing Spondylitis Quality of Life (ASQoL). Nominal p values are without multiple comparison adjustments.Results At month 3, PtGA, Pain, PGJS, SF-36v2 Physical Component Summary (PCS), physical functioning (PF), bodily pain (BP), vitality and social functioning (SF) domains, FACIT-Fatigue Total score, EQ-5D-3L pain/discomfort, EQ-VAS and ASQoL scores exceeded placebo with both tofacitinib doses (role physical [RP] with 10 mg twice daily only; p≤0.05). Patients reporting improvements ≥MCID (%) in PtGA, PGJS, Pain, ASQoL and SF-36v2 PCS, PF, RP, BP, SF (both tofacitinib doses) exceeded placebo (p≤0.05).Conclusion TNFi-IR patients with PsA receiving tofacitinib reported statistically and clinically meaningful improvements in PROs versus placebo over 3 months, which were maintained to month 6. Despite lower baseline scores, these improvements were similar to the csDMARD-IR TNFi-naive OPAL Broaden trial.https://rmdopen.bmj.com/content/5/1/e000808.full |
| spellingShingle | Philip J Mease Dafna D Gladman Vibeke Strand Kurt de Vlam Jose A Covarrubias-Cobos Joseph C Cappelleri Thijs Hendrikx Ming-Ann Hsu Linda Chen Elizabeth Kudlacz Joseph Wu Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond RMD Open |
| title | Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond |
| title_full | Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond |
| title_fullStr | Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond |
| title_full_unstemmed | Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond |
| title_short | Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond |
| title_sort | effect of tofacitinib on patient reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase iii randomised controlled trial opal beyond |
| url | https://rmdopen.bmj.com/content/5/1/e000808.full |
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