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Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: patient-reported outcomes from the 24-month Phase 3 ORAL Scan study

Author

Strand V1, van der Heijde D2, Tanaka Y3, Keystone E4, Kremer J5, Zerbini CAF6, Cardiel MH7, Cohen S8, Nash P9, Song YW10, Tegzová D11, Gruben D12, Wallenstein G13, Connell CA12, Fleischmann R8; ORAL Scan investigators. Clin Exp Rheumatol. 2019 Dec 19. [Epub ahead of print]

Author Information

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

2 Leiden University Medical Center, Leiden, The Netherlands.

3 First Department of Internal Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.

4 Mount Sinai Hospital, University of Toronto, Toronto, Canada.

5 Albany Medical College, Albany, NY, USA.

6 Centro Paulista de Investigação Clinica, São Paulo, Brazil.

7 Centro de Investigacion Clinica de Morelia, Mexico.

8 Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.

9 University of Queensland, Australia.

10 Department of Internal Medicine, Medical Research Center, Seoul National University College of Medicine, Seoul, Korea.

11 Institute of Rheumatology, Prague, Czech Republic.

12 Pfizer Inc, Groton, CT, USA.

13 Pfizer Inc, Groton, CT, USA. genewallenstein@yahoo.com.

Abstract

OBJECTIVES: 

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we present data from the completed Phase 3 randomised controlled trial (RCT) ORAL Scan (NCT00847613), which evaluated the impact of tofacitinib on patient-reported outcomes (PROs) through 24 months in patients with active RA and inadequate responses to methotrexate (MTX-IR).

METHODS: 

Patients were randomised 4:4:1:1 to receive tofacitinib 5 or 10 mg twice daily (BID), or placebo advanced to tofacitinib 5 or 10 mg, plus background MTX. Patients receiving placebo advanced to tofacitinib at month 3 (non-responders) or month 6 (remaining patients). Mean changes from baseline in PROs, assessed at months 1-24, included Health Assessment Questionnaire-Disability Index, Patient Global Assessment of disease activity (visual analogue scale [VAS]), Patient Assessment of Arthritis Pain (VAS), health-related quality of life (Short Form-36 version 2), Functional Assessment of Chronic Illness Therapy-Fatigue and Medical Outcomes Study-Sleep.

RESULTS: 

Overall, 539/797 (67.6%) patients completed 24 months' treatment. At month 3, tofacitinib-treated patients reported signi cant (p<0.05) mean changes from baseline versus placebo across all PROs, and significantly more patients reported improvements ≥ minimum clinically important differences versus placebo. Improvements in PROs with tofacitinib were sustained to month 24. Following advancement to tofacitinib, placebo-treated patients generally reported changes of similar magnitude to tofacitinib-treated patients.

CONCLUSIONS: 

Patients with RA and MTX-IR receiving tofacitinib 5 or 10 mg BID plus MTX reported significant and clinically meaningful improvements in PROs versus placebo at month 3, which were sustained through 24 months.