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      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

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          Abstract

          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.

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          Most cited references31

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          Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors

          Tofacitinib is an oral Janus kinase inhibitor that is under investigation for the treatment of psoriatic arthritis. We evaluated tofacitinib in patients with active psoriatic arthritis who had previously had an inadequate response to tumor necrosis factor (TNF) inhibitors.
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            The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales.

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              Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research.

              The minimal clinically important difference (MCID) for an instrument is a much sought after, but elusive figure. In this review we will highlight new findings in this area, including taxonomy of MCID, methods used to ascertain MCID, the perspective taken for evaluating importance, and other sources of variation for MCID values. In the end we believe the MCID will be a context-specific value rather than a fixed number. The review highlights the need to do methodological research in this area, especially concurrent comparisons between approaches, or across different patient groups. There are many faces to the MCID, it is not a simple concept, nor simple to calculate.
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                Author and article information

                Journal
                RMD Open
                RMD Open
                rmdopen
                rmdopen
                RMD Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2056-5933
                2019
                11 January 2019
                : 5
                : 1
                : e000808
                Affiliations
                [1 ] departmentDivision of Immunology/Rheumatology , Stanford University , Palo Alto, California, USA
                [2 ] departmentDepartment of Rheumatology , University Hospitals Leuven , Leuven, Belgium
                [3 ] Unidad Reumatologica Las Americas S.C.P ., Mérida, Yucatán, Mexico
                [4 ] Swedish Medical Center and University of Washington , Seattle, Washington, USA
                [5 ] University of Toronto, Toronto Western Hospital , Toronto, Ontario, Canada
                [6 ] Pfizer Inc , New York, New York, USA
                [7 ] Pfizer Inc , Groton, Connecticut, USA
                [8 ] Pfizer Inc , Collegeville, Pennsylvania, USA
                Author notes
                [Correspondence to ] Vibeke Strand; vstrand@ 123456stanford.edu
                Article
                rmdopen-2018-000808
                10.1136/rmdopen-2018-000808
                6340607
                30713722
                a9261b52-ed7d-4813-940a-9c6faab3b8f5
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 24 August 2018
                : 05 October 2018
                : 13 October 2018
                Funding
                Funded by: Pfizer Inc;
                Categories
                Psoriatic Arthritis
                1506
                Original article
                Custom metadata
                unlocked

                dmards (biologic),psoriatic arthritis,patient perspective,outcomes research,treatment

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