Hirata S, Kazuyoshi Saito K, Satoshi Kubo S, et al. 2013 Discontinuation of adalimumab(Drug information on 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(Drug information on 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.