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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


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.



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).


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.


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.


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.