(76) Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention

Background: : Eptinezumab, an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb), has demonstrated early and sustained migraine-preventive effects and a favorable safety profile in adults with migraine in clinical trials.

Objective: : This analysis assessed retention rates across select phase 3/3b trials of eptinezumab, as well as similarly designed trials of subcutaneous anti-CGRP mAbs.

Methods: : Clinical trial data were used to assess retention rates for adults treated with eptinezumab and other anti-CGRP mAbs for prevention of migraine. Included eptinezumab trials were the 104-week, open label, single-arm PREVAIL trial and 72-week DELIVER trial (included 24-week placebo [PBO]-controlled and 48-week dose-blinded extension period). Similar trials of other anti-CGRP mAbs relative to PREVAIL (≥48-week trials in chronic migraine [CM]) were included: REGAIN (galcanezumab), phase 2 trial (erenumab) and HALO CM (fremanezumab). For DELIVER (trial in participants for whom 2-4 migraine preventive treatments have failed), similar trials of other anti-CGRP mAbs were included: CONQUER (galcanezumab), LIBERTY (erenumab), and FOCUS (fremanezumab). In general, retention rates were calculated by dividing number of participants who completed the trial/visit by number of participants enrolled/randomized to active treatment.

Results: : Eptinezumab demonstrated high retention rates of 78.1% at the end of the PREVAIL trial (Week 104) and 90.4% at the end of the DELIVER extension period (Week 72). Eptinezumab exhibited high long-term retention rates throughout PREVAIL in participants with CM, with retention rates of 92.2% and 89.8% at Weeks 48 and 60, respectively. The retention rate for galcanezumab was 80.7% at Week 48 (end of REGAIN); retention rates for erenumab and fremanezumab were 74.1% and 79.0%, respectively, at Week 64 (end of the phase 2 and HALO CM trials, respectively). Among individuals with migraine for whom 2-4 prior migraine preventive treatments have failed, retention rates were high (>95%) across anti-CGRP mAbs at Weeks 12 and 24. Retention rates for included trials beyond 24 weeks were only available for eptinezumab (DELIVER; >90% through Week 72) and erenumab (LIBERTY; 85% by Week 64).

Conclusions: : Eptinezumab demonstrated high, long-term retention rates for preventive treatment in participants with CM and those with migraine for whom 2-4 prior migraine preventive treatments have failed. These findings suggest a high level of participant satisfaction with continued treatment of eptinezumab.

Sponsorship:: H. Lundbeck A/S (Copenhagen, Denmark)