Overall Well-Being in RA Achieved with Tofacitinib

March 30, 2016

Tofacitinib and adalimumab improve physical function, pain, fatigue, well-being, emotional health and overall disease activity in patients with rheumatoid arthritis.

Tofacitinib and adalimumab improve physical function, pain, fatigue, well-being, emotional health and overall disease activity in patients with rheumatoid arthritis, a study shows.

The study is based on an analysis of the phase III ORAL Standard trial, a 12-month, randomized controlled trial of rheumatoid arthritis patients who had an inadequate response to methotrexate, but when tofacitinib or adalimumab was added to the treatment regime, patients experienced improvements in outcomes across the board, researchers wrote in the Feb. 29 online issue of Rheumatology.

“Patients with moderate to severe RA and inadequate responses to methotrexate reported improvements across a broad range of patient reported outcomes with tofacitinib 5 and 10 mg twice daily and adalimumab (40 mg once every two weeks) that were significantly superior to placebo,” the authors wrote.

The ORAL Standard trial (NCT00853385) enrolled 717 patients (75-83 percent female with mean disease range from 6.9 to nine years) of which 77.5 percent completed the 12-month trial. Patients were randomly assigned to one of four study arms:  (1) methotrexate plus tofacitinib 5 mg twice daily (2) tofacitinib 10 mg twice daily (3) placebo or (4) an active control group that received the tumor necrosis factor inhibitor adalimumab (40 mg once every 2 weeks).

Led by Gene Wallenstein, Ph.D., of Pfizer, researchers found significant differences in improvements in all patient reported outcomes at three months with tofacitinib 10 mg twice daily - and, these were sustained for 12 months.

Like tofacitinib, adalimumab was associated with improved patient-reported outcomes versus placebo. The study was not designed to test tofacitinib vs. adalimumab, the authors wrote. [[{"type":"media","view_mode":"media_crop","fid":"47219","attributes":{"alt":"(©PHOTOCREO/Shuttersstock.com)","class":"media-image media-image-right","id":"media_crop_2385547646672","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5544","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.008px; line-height: 1.538em; float: right;","title":"(©PHOTOCREO/Shuttersstock.com)","typeof":"foaf:Image"}}]]

“In this randomized controlled trial, treatment with tofacitinib 5 and 10 mg twice daily, or adalimumab, all resulted in statistically significant and clinically meaningful improvements versus placebo in patient reported outcomes that approached maximal at month 3, with further smaller improvements until month 6,” the authors wrote.

“These results indicate that tofacitinib not only improves physical function, global assessments of disease activity, pain and fatigue, but also other aspects of HRQoL (health-related quality of life), particularly well-being and emotional health of patients with RA,” the authors wrote.

 

Disclosures:

The ORAL Standard study was designed by Pfizer and academic partners, and was entirely funded by Pfizer, and study authors disclosed consulting fees and research funds from Pfizer and numerous other pharmaceutical firms. Dr. Wallenstein and four other study coauthors are employees and shareholders of Pfizer, they disclosed in the 

Rheumatology 

paper.

 

 

References:

Strand V, van Vollenhoven RF, Lee EB, et al. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritisRheumatology. 2016;299:53. Published online ahead of print Feb. 29, 2016. doi: 10.1093/rheumatology/kev442.