Fifty Percent of Patients with Ulcerative Colitis Treated with Mirikizumab Achieved Clinical Remission at One Year in Lilly's Pivotal Phase 3 Study
Nearly all mirikizumab-treated patients who achieved clinical remission at one year were not taking steroids
"Ulcerative colitis can significantly impact a patient's quality of life, including fecal incontinence due to bowel movement urgency that may even result in individuals wearing diapers. Patients often spend years trying different treatments, including steroids and TNF inhibitors, hoping to achieve remission, reduce inflammation and get relief from painful, disruptive and sometimes embarrassing symptoms," said
Mirikizumab was superior to placebo on clinical, symptomatic, endoscopic and histologic endpoints regardless of previous failure to TNF inhibitors, tofacitinib or other biologics. Among patients who had responded to 12-week induction treatment with mirikizumab, one-half of patients receiving mirikizumab maintenance treatment (49.9%, n=182/365) achieved clinical remission at one year compared to one-fourth of patients on placebo (25.1%, n=45/179, p<0.001). Nearly two-thirds of patients receiving mirikizumab who achieved clinical remission at 12 weeks maintained clinical remission at one year (63.6%, n=91/143) compared to one-third of patients on placebo (36.9%, n=24/65, p<0.001). Nearly all patients receiving mirikizumab who achieved clinical remission at one year were not taking corticosteroids for at least three months prior to the end of maintenance treatment (97.8%, n=178/182).
A patient-centric, 11-point scale developed by
Patients receiving mirikizumab in the LUCENT-2 study reported a lower frequency of serious adverse events compared to placebo (mirikizumab: 3.3%, n=13/389; placebo: 7.8%, n=15/192) and were less likely to discontinue the study due to adverse events (mirikizumab: 1.5%, n=6/389; placebo: 8.3%, n=16/192). The overall safety profile was consistent with previous mirikizumab studies in UC and consistent with that of other anti-IL23p19 antibodies in other therapeutic areas.
"We're thrilled to share patients with UC receiving mirikizumab achieved long-term clinical remission, improvement in hard-to-treat symptoms like bowel urgency, and remission of acute inflammation in the colon," said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at
In the first quarter of 2022,
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Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23. Mirikizumab is being studied for the treatment of immune-mediated diseases, including ulcerative colitis and Crohn's disease.
About The LUCENT-2 Study
LUCENT-2 (NCT03524092) is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 maintenance study in patients with moderately-to-severely active ulcerative colitis who have previously failed conventional and/or biologic therapies and/or JAK inhibitors and required additional treatment to manage their disease, and who have also completed the 12-week induction study (LUCENT-1). For LUCENT-2, the primary analysis was based on patients who had responded to mirikizumab induction treatment in LUCENT-1 and were re-randomized to receive mirikizumab subcutaneously or placebo for an additional 40 weeks.
Patients who responded to mirikizumab in the 12-week induction study (LUCENT-1) and randomized into LUCENT-2 were on average 42.7 years old and had lived with UC for approximately 6.8 years since first experiencing symptoms at an average age of 36.1 years. Approximately 58.5% (n=318/544) of patients were male. Three out of five patients (62.7%, n=341/544) had severe intestinal mucosal inflammation, as measured by a Mayo endoscopic subscore of 3. 35.3% (n=192/544) had previously failed one or more biologics or tofacitinib, and 37.3% (n=203/544) had baseline corticosteroid use.
Clinical remission, the primary endpoint of the LUCENT-2 clinical trial, is achieved when inflammation of the colon is controlled or resolved, leading to normalization or near-normalization of symptoms such as stool frequency and bleeding, and is defined by a stool frequency (SF) score = 0, or 1 with a ≥1-point decrease from baseline, a rectal bleeding (RB) score = 0, and endoscopy score (ES) = 0 or 1, excluding friability, which is the propensity for tissue that covers the inside of the colon (also known as colonic mucosa) to be damaged or bleed because of contact with an endoscope or biopsy instrument.
Clinical response is measured by the decrease in the modified Mayo score of ≥2 points and ≥30% decrease from baseline (BL) and decrease of ≥1 point in the RB subscore from baseline or a RB score of 0 or 1.
Rather than using a binary scale to measure the presence or absence of bowel urgency,
About the LUCENT Clinical Trial Program
The LUCENT Phase 3 clinical development program for mirikizumab began in 2018 and includes LUCENT-1, LUCENT-2 and LUCENT-3. LUCENT-2 is a multicenter, randomized, double-blind, placebo-controlled maintenance study of mirikizumab in patients who have completed the 12-week induction study (LUCENT-1). Patients in LUCENT-1 who achieved clinical response with mirikizumab induction therapy were re-randomized to receive mirikizumab or placebo subcutaneously for an additional 40 weeks in the LUCENT-2 study. LUCENT-3 (NCT03519945) is an open label extension study for eligible patients who have participated in mirikizumab UC trials. Additional data from the Phase 3 LUCENT program, the first Phase 3 study of an anti-IL23p19 antibody in UC, will be disclosed at upcoming congresses and in publications in 2022.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about mirikizumab as a potential treatment for people with ulcerative colitis and other diseases and the timeline for future readouts, presentations, regulatory action and other milestones relating to mirikizumab and its clinical trials, and reflects
Marlo Scott; email@example.com; +1-317-407-8879 (Lilly media)
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