Induction and Prolonged Induction With Mirikizumab in Ulcerative Colitis—A Prospective, Real‐World Study From the Sicilian Network for Inflammatory Bowel Disease (SN‐IBD)
Source: PubMed Central Open Access, NCBI / U.S. National Library of Medicine
ABSTRACT Background Mirikizumab (MIRI), an IgG4 monoclonal antibody targeting IL‐23 p19, was recently licensed for ulcerative colitis (UC). Most available data come from the pivotal trials, but real‐life data are scant. We aimed to evaluate the effectiveness and safety of MIRI in a real‐world setting. ueg270244-sec-0001 Methods UC patients from 12 centres of the SN‐IBD were prospectively enrolled. The primary endpoints were clinical response, steroid‐free remission (SFR), and reduction of urgency at week 12 and at week 24. As secondary endpoint, the need for prolonged induction was considered. All patients received 3 infusions at monthly intervals of 300 mg MIRI; in case of inadequate response, the induction period was prolonged. Urgency was determined by means of the Urgency Numerical Rating Scale (UNRS). ueg270244-sec-0002 Results One hundred and five patients were included. Previous failures to 2 or more lines of advanced therapies were present in 74% of patients. At week 12, 24% of patients achieved a clinical response and 53% achieved SFR. At week 24 (= 71), the rates were 20% and 68%, respectively. The median urgency score decreased from 6 at baseline to 2 at week 12 and to 1 at week 24 (< 0.001, both). Prolonged induction was necessary to half of patients. Adverse events were reported in 5% of patients. Treatment failures occurred in 14 patients (13%). ueg270244-sec-0003 Conclusions Our real‐life study confirmed the short‐term effectiveness and safety of MIRI in patien
Abstract
ABSTRACT Background Mirikizumab (MIRI), an IgG4 monoclonal antibody targeting IL‐23 p19, was recently licensed for ulcerative colitis (UC). Most available data come from the pivotal trials, but real‐life data are scant. We aimed to evaluate the effectiveness and safety of MIRI in a real‐world setting. ueg270244-sec-0001 Methods UC patients from 12 centres of the SN‐IBD were prospectively enrolled. The primary endpoints were clinical response, steroid‐free remission (SFR), and reduction of urgency at week 12 and at week 24. As secondary endpoint, the need for prolonged induction was considered. All patients received 3 infusions at monthly intervals of 300 mg MIRI; in case of inadequate response, the induction period was prolonged. Urgency was determined by means of the Urgency Numerical Rating Scale (UNRS). ueg270244-sec-0002 Results One hundred and five patients were included. Previous failures to 2 or more lines of advanced therapies were present in 74% of patients. At week 12, 24% of patients achieved a clinical response and 53% achieved SFR. At week 24 (= 71), the rates were 20% and 68%, respectively. The median urgency score decreased from 6 at baseline to 2 at week 12 and to 1 at week 24 (< 0.001, both). Prolonged induction was necessary to half of patients. Adverse events were reported in 5% of patients. Treatment failures occurred in 14 patients (13%). ueg270244-sec-0003 Conclusions Our real‐life study confirmed the short‐term effectiveness and safety of MIRI in patients with UC especially in relieving bowel urgency. The flexible induction schedule allows an additional gain in response and remission. ueg270244-sec-0004 Key Summary Summarise the established knowledge on this subject ◦ Mirikizumab is a monoclonal antibody targeting IL‐23 p19 that was recently approved for the treatment of ulcerative colitis. ◦ While mirikizumab has demonstrated efficacy in inducing and maintaining remission in clinical trials, real‐world evidence remains limited. simple What are the significant and/or new findings of this study? ◦ We prospectively enrolled UC patients starting Mirikizumab. The primary endpoints were clinical response, steroid‐free remission, and reduction of urgency at week 12 and at week 24. As secondary endpoint, the need for prolonged induction was considered. ◦ In a real‐world, highly refractory UC population, mirikizumab proved to be effective and safe with a marked improvement in bowel urgency. ◦ A flexible, prolonged induction strategy provided additional benefits, enhancing clinical response and remission rates. simple bullet highlights http://www.w3.org/1999/xlink anchor jats-graphic-1 portrait UEG2-14-e70244-g002.jpg anchor graphic portrait graphical