Brief hiatus in baricitinib therapy led to minor RA symptom recurrence
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Short interruptions in baricitinib treatment are associated with minor increases in rheumatoid arthritis symptoms, which resolved after recontinuation, according to data published in Arthritis Research & Therapy.
“As a small molecule with a short half-life (approximately 12 [hours] in RA patients), baricitinib may offer advantages over injectable biologic therapies with respect to ease and speed of withdrawal and re-initiation,” Paul Emery, MD, of the Leeds Musculoskeletal Biomedical Research Center, Chapel Allerton Hospital, in the United Kingdom, and colleagues wrote.
They added: “Baricitinib improved signs and symptoms of RA in four phase 3, placebo- and active-controlled studies in patients with active RA who were naive to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) (RA-BEGIN) or had an inadequate response to previous treatment with methotrexate (MTX) (RA-BEAM), csDMARDs (RA-BUILD), or biologic DMARDs (RA-BEACON).”
To examine the impact of temporary treatment interruptions of baricitinib (Olumiant, Eli Lilly) among patients with moderate-to-severe RA, Emery and colleagues studied data from four phase 3 clinical trials. In these studies, researchers reported the timing, reason and duration of investigator-initiated temporary treatment interruptions.
Study populations included 684 patients in RA-BUILD and 527 patients in RA-BEACON with active RA, who were randomly assigned 1:1:1 to receive placebo or 2- or 4-mg baricitinib once daily. Also included were 1,305 patients in RA-BEAM, who were randomly assigned 3:3:2 to receive placebo or 4-mg of baricitinib daily, or a subcutaneous injection of adalimumab (Humira, AbbVie) every 2 weeks.
Lastly, the researchers analyzed 588 patients in RA-BEGIN, who were randomly assigned 4:3:4 to receive either oral methotrexate every week, 4 mg of baricitinib daily, or 4 mg of baricitinib daily plus weekly methotrexate.
In their post-hoc analysis, Emery and colleagues evaluated changes in symptom scores during interruptions and after the resumption of treatment. They also examined interruptions for reoccurrence of adverse events or laboratory abnormalities, following retreatment.
According to the researchers, interruptions occurred in larger proportions of baricitinib groups — 18% for both 2- and 4-mg regimens, compared with 9% in the placebo group — in the RA-BEACON study only. In the active comparator-controlled studies, the lowest rates of interruption were in the baricitinib monotherapy arm, at 9%, in RA-BEGIN, with similar proportions for baricitinib, at 10%, and adalimumab, at 9%, in RA-BEAM.
Adverse events were the most common cause for interruption. However, they rarely reoccurred after the drug was restarted. Most interruptions lasted2weeks or less. Reports from the studies suggested modest symptom increases during interruption, with a return to pre-interruption levels or better after the drug was restarted. Interruptions had no impact on long-term efficacy outcomes.
“Adverse events were the most common reason for interruption, but their reoccurrence after drug restart were rare,” Emery told Healio Rheumatology. “Most interruptions lasted 2 weeks or less, with return to pre-interruption levels or better after resumption. Interruptions had no impact on long-term efficacy outcomes. Brief interruptions of baricitinib were associated with minor increases in RA symptoms that resolved following retreatment. This is useful information for clinicians, as temporary interruption of antirheumatic therapy is common in the care of patients with RA.”
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