Low-Activity RA Patients May Stop Adalimumab

October 9, 2013

Low disease activity rheumatoid arthritis patients may be able to discontinue adalimumab, while maintaining methotrexate use, and stay in remission, according to Japanese researchers.

Hirata S, Kazuyoshi Saito K, Satoshi Kubo S, et al. 2013 Discontinuation of adalimumab after attaining disease activity score 28-erythrocyte sedimentation rate remission in patients with rheumatoid arthritis (HONOR study): an observational study.Arthritis Research & Therapy (2013) doi:10.1186/ar4318 First published online: September 25, 2013.

Some long-term rheumatoid arthritis (RA) patients with low disease activity can stop taking adalimumab (Humira) and may remain in remission solely with methotrexate (MTX) therapy, a small Japanese study suggests.

More than half of the RA study patients, who started out with a disease activity score-erythrocyte sedimentation rate (DAS28-ESR) of <2.6 after 24 weeks of MTX plus adalimumab (ADA) maintained that level without ADA for another 6 months, most with no evidence of radiographic progression at one year.

The results indicate that it may be possible to halt the disease process even in the course of long-standing RA, which would particularly benefit patients who need to discontinue TNF-α inhibitors. However, larger trials are needed to verify these findings, and patients who stop anti-TNF drugs must be carefully monitored, the researchers say.

The HONOR study (Humira discontinuation without functional and radiographic damage progressioN follOwing sustained Remission) is an observational non-randomized study of voluntary ADA cessation among 197 RA patients (mean age 59.5), most of them women, and with a mean disease duration of 7 years.

In the cohort, 35% of the patients reached DAS28-ESR <2.6 for at least 24 weeks on ADA plus MTX. A group of 50 patients who voluntarily gave up ADA were followed, with 18 patients continuing on both the drugs as controls.

In the ADA-free group, 58% had DAS28-ESR of <2.6 at 24 weeks after drug discontinuation, with good function and a mean health assessment questionnaire-disability index (HAQ-DI) of 0.1. Modified total Sharp scores showed progression evidence in only two of 39 radiographically assessed ADA-free patients.

Among those not achieving low-disease activity after stopping ADA: 12 patients  experienced an exacerbation; half agreed to restart ADA; and 3 agreed to increase MTX. Although patients restarting ADA had a better response than those only increasing MTX, it was not sufficient in the majority, researchers say.