medwireNews: The majority of patients with early rheumatoid arthritis (RA) maintain low disease activity (LDA) for up to 3 years after discontinuing adalimumab (ADA) therapy, Japanese researchers report.
In the HOPEFUL-3 study, the team followed up participants who had completed both HOPEFUL-1 – in which patients received ADA or placebo plus methotrexate (MTX) for 26 weeks, followed by a 26-week period when all patients received ADA plus MTX – and then HOPEFUL-2, in which patients received ADA plus MTX (ADA continuation group) or MTX alone (ADA discontinuation group) for 52 weeks.
Participants who had achieved LDA at the end of HOPEFUL-1, defined as a score of less than 3.2 on the 28-joint Disease Activity Score based on C-reactive protein, were followed up for an additional 104 weeks in HOPEFUL-3.
In all, 79.7% of 74 patients in the ADA discontinuation group had LDA at the end of HOPEFUL-3 (week 208), indicating that “the majority of patients were in LDA at the end of the study period,” report the authors in Arthritis Research & Therapy.
Nevertheless, this was a significantly lower proportion of patients than those in the ADA continuation group, 95.1% of whom had LDA at week 208.
The researchers point out, however, that patients who discontinued ADA were significantly less likely to experience an adverse event than those who continued the drug, at rates of 9.7% and 32.9%, respectively.
“Although the use of biological agents leads to clinical, functional, and structural remission, continuous use of these drugs may lead to adverse events, particularly serious infection,” say Yoshiya Tanaka (University of Occupational and Environmental Health, Kitakyushu) and colleagues.
“As ADA discontinuation is associated with a lower incidence of adverse events, physicians should weigh the risks and benefits of ADA discontinuation,” they add.
The authors caution that because HOPEFUL-3 was observational, and participants were not randomly assigned to treatment groups during HOPEFUL-2, “potential differences in disease and treatment perception of patients and their doctors cannot be excluded.”
“Thus, the results of this study were not conclusive,” they emphasize.
However, Tanaka and colleagues believe that their findings indicate that “long-term discontinuation of ADA treatment might be a feasible and beneficial therapeutic option for patients with early RA who achieved LDA.”
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