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Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial

Author

Strand V1, Mysler E2, Moots RJ3, Wallenstein GV4, DeMasi R5, Gruben D4, Soma K4, Iikuni N6, Smolen JS7, Fleischmann R8. RMD Open. 2019 Oct 1;5(2):e001040. doi: 10.1136/rmdopen-2019-001040. eCollection 2019

Author Information

1 Division of Immunology/Rheumatology, Stanford University, Palo Alto, California, USA.

2 Reumatólogo en Organización Médica de Investigación, Buenos Aires, Argentina.

3 Department of Musculoskeletal Biology, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.

4 Pfizer Inc, Groton, Connecticut, USA.

5 Pfizer Inc, Collegeville, Pennsylvania, USA.

6 Pfizer Inc, New York, New York, USA.

7 Division of Rheumatology, Medical University of Vienna, Vienna, Austria.

8 Rheumatology Division, Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA.

Abstract

OBJECTIVE: 

To provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis(RA) with inadequate response to MTX (MTX-IR).

METHODS: 

ORAL Strategy (NCT02187055), a phase IIIB/IV, head-to-head, randomised controlled trial, assessed non-inferiority between tofacitinib 5 mg two times per day monotherapy, tofacitinib 5 mg two times per day+MTX and ADA 40 mg every other week+MTX. PROs assessed included the following: Patient Global Assessment of disease activity (PtGA), Pain, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue and 36-Item Short-Form Health Survey (SF-36) summary and domain scores.

RESULTS: 

Substantial improvements from baseline were reported across all PROs in all treatment arms, which, in the majority, met or exceeded minimum clinically important differences. Compared with tofacitinib monotherapy, tofacitinib+MTX combination treatment conferred significantly greater improvements in PtGA, Pain and SF-36 physical component summary scores at month 6. Statistically or numerically greater improvements were often, but not uniformly, reported for combination treatments compared with tofacitinib monotherapy at other time points.

CONCLUSION: 

Treatment with tofacitinib+MTX, ADA+MTX and tofacitinib monotherapy resulted in clinically meaningful improvements in PROs in MTX-IR patients with RA. These were comparatively greater with combination treatments versus tofacitinib monotherapy, although differences between treatment arms were small, limiting our ability to confer clinical meaning.

TRIAL REGISTRATION NUMBER: 

NCT02187055.