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Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials
G.V. Wallenstein1, K.S. Kanik2, B. Wilkinson3, S. Cohen4, M. Cutolo5, R. Fleishmann6, M.C. Genovese7, J. Gomez Reino8, D. Gruben9, J. Kremer10, S. Krishnaswami11, E.B. Lee12, V. Pascual-Ramos13, V. Strand14, S.H. Zwillich15
- Pfizer Inc, Groton, CT, USA. gene.wallenstein@pfizer.com
- Pfizer Inc, Groton, CT, USA.
- Pfizer Inc, Groton, CT, USA.
- Metroplex Clinical Research Center, Dallas, TX, USA.
- University of Genoa, Italy.
- Metroplex Clinical Research Center, Dallas, TX, USA.
- Stanford University, Stanford, CA, USA.
- Hospital Clinico Universitario, Santiago de Compostela, Spain.
- Pfizer Inc, Groton, CT, USA.
- Albany Medical College, Albany, NY, USA.
- Pfizer Inc, Groton, CT, USA.
- Seoul National University College of Medicine, Seoul, Republic of Korea.
- Instituto Nacional de Ciencias Médicas y Nutrición-Salvador Zubirán, Mexico City, Mexico.
- Stanford University, Stanford, CA, USA.
- Pfizer Inc, Groton, CT, USA.
CER8609
2016 Vol.34, N°3
PI 0430, PF 0442
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PMID: 27156561 [PubMed]
Received: 15/05/2015
Accepted : 02/11/2015
In Press: 28/04/2016
Published: 30/05/2016
Abstract
OBJECTIVES:
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we investigated the effects of tofacitinib on patient-reported outcomes (PRO) in patients with active RA.
METHODS:
Two, 6-month, double-blind, placebo-controlled Phase 2b studies were performed. The combination study evaluated patients with inadequate response to methotrexate who received tofacitinib 1-15 mg twice daily (BID), 20 mg once daily or placebo, on background methotrexate. In the monotherapy study, patients with inadequate response to disease-modifying anti-rheumatic drugs received tofacitinib 1-15 mg BID, adalimumab 40 mg once every other week or placebo. PROs measured were: Patient’s Assessment of Arthritis Pain (PAAP), Patient’s Assessment of Disease Activity, HAQ-DI, FACIT-F and SF-36.
RESULTS:
In the combination study (n=507), significant improvements (p<0.05) versus placebo were observed at Week 12 in PAAP (visual analogue scale) and HAQ-DI for all tofacitinib groups. In the monotherapy study (n=384), significant improvements in PAAP were observed at Week 12 for tofacitinib 5, 10 and 15 mg BID, and in HAQ-DI for tofacitinib 3, 5, 10 and 15 mg BID. Significant improvements versus placebo were seen at Week 2 in PAAP (both studies) and HAQ‑DI (monotherapy study) with tofacitinib, and were maintained throughout each study. In both studies, improvements in several domains of the SF-36 in the tofacitinib groups were observed at Weeks 12 and 24.
CONCLUSIONS:
In patients with active RA, tofacitinib, either in combination with methotrexate or as monotherapy, demonstrated rapid and sustained improvement in pain, physical functioning and health-related quality of life.