Format

Send to

Choose Destination
Rheumatology (Oxford). 2016 Jun;55(6):1031-41. doi: 10.1093/rheumatology/kev442. Epub 2016 Feb 29.

Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.

Author information

1
Private residence, CA, USA.
2
Department of Medicine, Karolinska Institute, Stockholm, Sweden.
3
Department of Internal Medicine, Seoul National University, Seoul, Republic of Korea.
4
Rheumatology Department, Metroplex Clinical Research Center, Dallas, TX.
5
Medicines Development Group, Pfizer Inc, Groton, CT and.
6
Medicines Development Group, Pfizer Inc, New York, NY, USA.
7
Medicines Development Group, Pfizer Inc, Groton, CT and gene.wallenstein@pfizer.com.

Abstract

OBJECTIVE:

To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX.

METHODS:

In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep).

RESULTS:

At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements ⩾minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements ⩾minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab.

CONCLUSION:

Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo.

KEYWORDS:

Janus kinase; patient-reported outcomes; phase 3; rheumatoid arthritis; tofacitinib

PMID:
26929445
PMCID:
PMC4870388
DOI:
10.1093/rheumatology/kev442
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center