Some RA Patients May Qualify for Adalimumab Break

December 5, 2013

More than three-fourths of long-term rheumatoid arthritis patients are able to stop taking adalimumab if they achieve deep remission, according to a Japanese study.

Tanaka Y, Hirata S, Kubo S, et al., Discontinuation of adalimumab after achieving remission in patients with established rheumatoid arthritis: 1-year outcome of the HONOR study. Ann Rheum Dis. 2013 Nov 28. doi: 10.1136/annrheumdis-2013-204016. [Epub ahead of print] Free full text.


A drug “holiday” is possible for established rheumatoid arthritis (RA) patients who stay in deep remission for a year after discontinuing adalimumab (Humira), this study from Japan suggests.

In the open-label, non-randomized study, 197 patients with active, moderate-to-severe RA (mean age 60.7, mean disease duration 8.9 years) were given subcutaneous injections of 40 mg adalimumab plus methotrexate every other week from July 2008 to April 2011.

A total of 75 patients achieved and maintained remission for at least six months and qualified for a period free from adalimumab. Among those, 52 agreed to discontinue the agent while 23 continued on the drug.

Remission was defined as having a sustained 28-joint disease activity, an erythrocyte sedimentation rate (DAS28-ESR) of less than 2.6, and remaining steroid-free with a stable methotrexate dose.

After one year, approximately 80% of patients judged to be in deep remission were able to sustain low disease activity compared to 42% of those with mild remission, leading the to researchers suggest that mild remission “may be insufficient for [adalimumab] discontinuation in established RA.”

The authors point out that re-starting adalimumab effectively returned 90% of patients with flare to DAS28-ESR of less than 3.2 withinsix months.

While equal numbers in the continuation group sustained or failed remission at one year (n=25, n=27, respectively), those able to sustain remission were generally younger, with shorter baseline disease duration, lower DAS28 and ESR values, and shorter adalimumab treatment periods.