medwireNews: Tapering to baricitinib 2 mg/day is possible for many patients with rheumatoid arthritis (RA) who have achieved sustained disease control on a 4 mg dose, indicates a long-term extension of a phase III study.
Treatment with baricitinib, a selective Janus kinase 1 and 2 inhibitor, for 48 weeks was more efficacious when maintained at the 4 mg/day dose for 48 weeks and there were small but significant increases in disease activity among the 278 individuals whose dose was tapered to 2 mg/day after at least 15 months on the higher dose. Yet, the team highlights, 67% of these tapered individuals maintained a low disease activity (LDA; Clinical Disease Activity Index [CDAI] score ≤10) and 33% stayed in remission (CDAI ≤2.8 at two consecutive visits at least 3 months apart).
The corresponding rates for the 281 patients who remained on the 4 mg/day dose were better, at 80% and 40%, the researchers acknowledge, and a significantly smaller proportion of these patients lost their disease control (CDAI >2.8), at 29% versus 43% of those whose dose was tapered.
But the researchers point out that two-thirds (66.7%) of the patients who tapered to 2 mg/day and lost their state of disease control regained LDA or remission 24 weeks after restarting baricitinib 4 mg/day, with 13 of the remaining 16 participants doing so at a later time point. In all, 18% of individuals in the 2 mg group and 10% in the 4 mg needed rescue medication.
Tsutomu Takeuchi (Keio University School of Medicine, Tokyo, Japan) and colleagues further found that adverse events were less common in the 2 mg group, at 59.2% versus 66.7% among individuals continuing at baricitinib 4 mg, with infections seen in 24.9% and 30.6% of participants, respectively.
The researchers note that a number of observations from this study support guidelines that recommend considering a DMARD taper for individuals who achieve sustained disease control. First, the 2 mg dose was “acceptably efficacious” for many patients, they say, “as evidenced by the fact that fewer than 1 in 5 dose-tapered patients were rescued back to 4 mg by their treating physicians.”
Second, in those who did need rescue therapy, prior control of disease activity could be re-established with a return to 4 mg baricitinib. Finally, they comment: “[A]s a general principle, as long as acceptable efficacy is not sacrificed, use of lower doses may be desirable from a safety perspective, in particular for chronic treatments that are relatively novel.”
The researchers conclude in the Annals of the Rheumatic Diseases: “[A]ttempted dose taper after induction of sustained RA control appears a reasonable consideration with baricitinib.”
By Catherine Booth
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