Extended mirikizumab dose produces UC response in initial nonresponders
Additional, extended treatment with mirikizumab helped produce a clinical response in patients with ulcerative colitis who initially did not respond to treatment, according to study results.
William J. Sandborn, MD, of the University of California, San Diego, and colleagues wrote that the drug (Lilly) has previously shown clinical efficacy in phase 2 studies of psoriasis and Crohn’s disease.
“Induction regimens evaluated in most clinical trials are no more than 12 weeks, and some patients, especially those less responsive to initial induction treatment, could potentially improve with additional IV induction doses of mirikizumab,” they wrote.
Researchers conducted an open-label extended induction period by continuing a double-blind trial in which patients with UC received 12 weeks of induction therapy with mirizkizumab or placebo. They offered patients who did not have clinical response at week 12 to participate in the open-label study for another 12 weeks.
Patients received either 600 mg of the drug (n = 20) or 1,000 mg (n = 64) every 4 weeks. Patients who achieved clinical response by week 24 continued to the extension maintenance period and received 200 mg of mirikizumab.
Among study participants who did not respond to the initial induction dosing of mirizkizumab, 50% of those who received 600 mg and 43.8% who received 1,000 mg in the 12-week extension achieved a clinical response, whereas 15% and 9.4% achieved clinical remission, respectively.
Among patients in the 600 mg group, 20% achieved endoscopic remission, whereas 15.6% of patients in the 1,000 mg group reached this endpoint.
Among patients who were initial nonresponders who later achieved clinical response at week 24, 65.8% maintained that response, 26.3% achieved clinical remission and 34.2% had endoscopic improvement at week 52 of maintenance therapy.
“These results indicate that a longer dosing period with mirikizumab may result in additional clinical benefit for those patients who do not respond to mirikizumab induction treatment,” Sandborn and colleagues wrote.