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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
V. Strand1, D. Van Der Heijde2, Y. Tanaka3, E. Keystone4, J. Kremer5, C.A. Zerbini6, M.H. Cardiel7, S. Cohen8, P. Nash9, Y.-W. Song10, D. Tegzová11, D. Gruben12, G. Wallenstein13, C.A. Connell14, R. Fleischmann15
- Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.
- Leiden University Medical Center, Leiden, the Netherlands.
- First Department of Internal Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.
- Mount Sinai Hospital, University of Toronto, Toronto, Canada.
- Albany Medical College, Albany, NY, USA.
- Centro Paulista de Investigação Clinica, São Paulo, Brazil.
- Centro de Investigacion Clinica de Morelia, Mexico.
- Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.
- University of Queensland, Australia.
- Department of Internal Medicine, Medical Research Center, Seoul National University College of Medicine, Seoul, Korea.
- Institute of Rheumatology, Prague, Czech Republic.
- Pfizer Inc, Groton, CT, USA.
- Pfizer Inc, Groton, CT, USA. genewallenstein@yahoo.com
- Pfizer Inc, Groton, CT, USA.
- Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.
for the ORAL Scan investigators
CER12492
2020 Vol.38, N°5
PI 0848, PF 0857
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PMID: 31858963 [PubMed]
Received: 10/06/2019
Accepted : 20/09/2019
In Press: 19/12/2019
Published: 02/10/2020
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.