Real-World Evidence For Control Of Chronic Migraine In Patients Meeting American Headache Society Criteria Who Received Calcitonin Gene‒Related Peptide Monoclonal Antibody Therapy Added To Onabotulinumtoxina

Authors: Andrew M. Blumenfeld, MD,1 Benjamin M. Frishberg, MD,1 Jack D. Schim, MD,1 Olivia Hughes, MS,2 Aubrey Manack Adams, PhD3

Combining onabotulinumtoxinA with CGRPmAbs can potentially be more effective than each therapy alone for preventing chronic migraine (CM). In the primary analysis cohort, records from 257 adults with CM receiving onabotulinumtoxinA with CGRPmAb showed that combination therapy was well tolerated and associated with additional reductions in monthly headache days (MHDs) and migraine-related disability (MIDAS). To better understand these findings, a sensitivity analysis was conducted in a cohort aligned to the AHS position statement (Headache. 2019;59:1). This study evaluated real-world safety and potential benefits of adding a CGRPmAb to onabotulinumtoxinA in CM patients.

Design and setting:
This was a retrospective, longitudinal chart review of adults with CM treated at 1 clinic (October 2018–November 2019) with ≥2 consecutive onabotulinumtoxinA cycles before ≥1 month of onabotulinumtoxinA plus CGRPmAb (erenumab, fremanezumab, or galcanezumab) combination treatment.

Patients in the sensitivity analysis cohort had ≥4 MHDs and MIDAS score >11 or 6-item Headache Impact Test score >50 at baseline.

Main outcome measures:
Charts at the CGRPmAb prescription visit (baseline) and ≤4 subsequent visits over ~12 months or less were reviewed for adverse events (AEs), discontinuations, MHDs, and MIDAS.

Of 300 charts reviewed, 172 met AHS criteria (mean age: 50 years; 83% women); 78% received erenumab (galcanezumab 17%; fremanezumab 5%). More patients discontinued CGRPmAbs (24%) than onabotulinumtoxinA (3%). AEs were reported in 27% of patients; the most common was constipation (10%). Mean MHDs were 21.4 before initiating onabotulinumtoxinA and 13.4 before adding CGRPmAb (baseline). MHDs significantly decreased from baseline at all visits (mean decrease at ~6 months: 3.9 days [95% CI: −5.0,−2.7]). After ~6 months, ≥58% had clinically meaningful MIDAS improvement (≥5-point decrease).

Combining onabotulinumtoxinA and CGRPmAb demonstrated clinically meaningful improvements in MHDs and MIDAS compared with onabotulinumtoxinA alone in patients with high baseline MHDs and disability treated according to AHS guidance.

Allergan (prior to its acquisition by AbbVie)


Andrew M. Blumenfeld, MD, has served on advisory boards for Aeon, AbbVie, Amgen, Alder, Biohaven, Teva, Supernus, Promius, Eaglet, and Lilly; and has received funding for speaking from AbbVie, Amgen, Pernix, Supernus, Depomed, Avanir, Promius, Teva, Eli Lilly and Company, Lundbeck, Novartis, and Theranica.

Benjamin M. Frishberg, MD, has received compensation for speaking from Teva, Lilly, Biohaven, Amgen, Novartis, and AbbVie; and has served on advisory boards for Lundbeck, Upsher-Smith, and Theranica.

Jack D. Schim, MD, has served on advisory boards for Aeon, AbbVie, Amgen, Biohaven, electroCore, Impel, Lilly, Lundbeck, Novartis, Promius, Revance, Teva, and Upsher-Smith; and has received compensation for speaking from AbbVie, Amgen, Biohaven, electroCore, Lilly, Lundbeck, Novartis, Promius, Teva, and Upsher-Smith. Olivia Hughes, MS, is an employee of ICON plc.

Aubrey Manack Adams, PhD, is an employee of AbbVie and may hold AbbVie stock.

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