P1048 Mirikizumab administration experience from Ulcerative Colitis patients: Survey data from the LUCENT clinical program

Abstract

Abstract Background Mirikizumab (MIRI) is an anti-IL-p19 antibody approved for moderately-to-severely active ulcerative colitis (UC). The recommended dose regimen has 2 parts: MIRI administration begins with intravenous (IV) infusion every 4 weeks (Q4W; 3 total) and is followed by maintenance dosing of subcutaneous (SC) injections (2 injections per dose) Q4W. Self-injection of SC MIRI is allowed after patient training. This study investigated patient satisfaction with and acceptability of MIRI IV infusions and SC injections during the LUCENT program. Methods This was a cross-sectional, 30-min, web-based survey. Patients were eligible if they were enrolled in LUCENT-3, a phase 3, open-label, long-term extension study of MIRI. Patients entered LUCENT-3 from the AMAC phase 2 study, or the LUCENT-1 and LUCENT-2 phase 3 studies. The survey covered patient satisfaction with and acceptability of IV infusions during the AMAC, LUCENT-1, or LUCENT-2 (extended or reinduction) studies and SC injections during the AMAC, LUCENT-2, or LUCENT-3 studies (Figure 1). Survey questions had responses based on 5-point Likert scales (Table 1). The survey was completed during LUCENT-3; MIRI SC injection experience at the time of survey varied from >2 yrs to ≥3 yrs. Subgroup analyses (primary: age and sex) were made using Fisher's exact tests. Results The survey was completed by 93 patients from 11 countries (mean age, 42.9 yrs; 54.8% male; 69.9% White). Most patients were satisfied or very satisfied with IV infusions (82.8%) and SC injections (91.4%). More than 89% of patients retrospectively reported that their satisfaction with either administration method remained the same or improved over time. Most patients indicated receiving 2 SC injections (96.8%) and receiving SC injections Q4W (97.8%) were somewhat or completely acceptable. Patients (95.1%) agreed that the self-injection device was easy to use. 97.8% were satisfied or very satisfied with the administration of MIRI overall, 96.8% agreed or strongly agreed that they would recommend MIRI to someone with UC, and 90.3% agreed or strongly agreed that improvements in their UC outweighed any dissatisfaction with the administration method. Acceptability of MIRI administration differed by age (p=0.0369). More patients aged ≥40 yrs than <40 yrs found the MIRI administration completely acceptable (98.2% vs. 89.2%). Overall satisfaction with the IV infusions differed by sex (p=0.0159). More females than males were satisfied or very satisfied with the IV infusions (92.9% vs.74.5%). Conclusion Most UC patients were satisfied with and acceptable of receiving MIRI by IV infusions and SC injections and found the dosing of 2 SC injections Q4W acceptable.