Weighing the Pros and Cons of Discontinuing Adalimumab in RA

A new study recommends that only a small minority of rheumatoid arthritis patients who are in clinical remission should discontinue adalimumab (Humira and Exemptia). The researchers found that remission was rarely maintained in patients with long-standing disease who discontinued adalimumab and flares were relatively common.

The study, published RMD Open, was a randomized, controlled, open-label pilot study of 31 patients who were in remission from rheumatoid arthritis. The patients were treated with a combination of adalimumab and methotrexate. They were  randomly assigned in a 1:1 ratio to continue with adalimumab and methotrexate, or take methotrexate monotherapy for 52 weeks.

[[{"type":"media","view_mode":"media_crop","fid":"45365","attributes":{"alt":"©ConstantinStanciu/Shutterstock.com","class":"media-image media-image-right","id":"media_crop_538723838981","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5191","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; height: 171px; width: 260px;","title":"©ConstantinStanciu/Shutterstock.com","typeof":"foaf:Image"}}]]

Researchers found that at 28 weeks, the primary end point for the trial, 94 percent of patients receiving combination therapy and 33 percent of patients in monotherapy were in remission (p=0.001). During this 28-week period, 50 percent of patients in combination therapy and 80 percent in monotherapy experienced a flare (p=0.001).

Flares were defined as having a DAS28 score of at least 2.6 or a change of more than 1.2 from baseline. Many of the patients with high DAS28 scores restarted adalimumab.

Researchers set out to determine if adalimumab could be discontinued while maintaining remission in patients with established disease who were already in stable clinical remission and were on combination therapy with adalimumab and methotrexate.

Adalimumab is a tumour necrosis factor (TNF) blocker, that is usually used indefinitely for rheumatoid arthritis once treatment begins, primarily due to the fact that there is little information about the feasibility of discontinuing the therapy, the researchers wrote.

“If remission could be sustained even after the cessation of anti-TNF therapy, this would have vast clinical (regarding long-term safety) as well as economic implications,” researchers wrote.

The findings suggests that “anti-TNF discontinuation might be feasible even in patients with established RA, but only for a small group of patients.  The identification of these patients is, of course, of interest,” researchers wrote. 

RELATED COVERAGE

• Adalimumab Improves Uveitis, Studies Show
• The Biosimilars are Coming
• Unexpected Findings for Adalimumab in RA, pSpA
• Adalimumab Safe and Effective for Non-Psoriatic SpA

References:

Katerina Chatzidionysiou, Carl Turesson, et. al. "A multicentre, randomised, controlled, open-label pilot study on the feasibility of discontinuation of adalimumab in established patients with rheumatoid arthritis in stable clinical remission,"

RMD Open

. Jan. 14, 2016. doi:10.1136/rmdopen-2015-000133