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. 2024 Aug;271(8):5402-5410.
doi: 10.1007/s00415-024-12470-6. Epub 2024 Jun 13.

Implications of therapy interruption on monthly migraine days and modified migraine disability assessment in patients treated with erenumab for chronic and episodic migraine: SQUARE study interim results

Andreas R Gantenbein  1   2 , Christophe Bonvin  3 , Christian P Kamm  4   5 , Christoph J Schankin  4 , Chiara Zecca  6   7 , Dominik Zieglgänsberger  8 , Gabriele Susanne Merki-Feld  9 , Heiko Pohl  10 , Nicole Rudolph  11 , Philippe Ryvlin  12 , Reto Agosti  13 , Elisabeth Schäfer  14   15 , Ina Meyer  14 , Monika Kulartz-Schank  14 , Michael E Arzt  14
Affiliations

Implications of therapy interruption on monthly migraine days and modified migraine disability assessment in patients treated with erenumab for chronic and episodic migraine: SQUARE study interim results

Andreas R Gantenbein et al. J Neurol. 2024 Aug.

Abstract

Background: There are limited real-world data in Switzerland examining the impact of erenumab, a fully human IgG2 monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, on migraine-related quality of life.

Objective: This 18-month interim analysis of 172 patients with episodic or chronic migraine from the SQUARE study provides first prospective insights on the impact of mandatory erenumab treatment interruption, following Swiss-reimbursement requirements, in a real-world clinical setting in Switzerland.

Findings: Recruited patients receiving 70 or 140 mg erenumab underwent treatment interruption on average 11.2 months after therapy onset with a mean duration of 4 months. There were sustained improvements in mean monthly migraine days (MMD) and migraine disability (mMIDAS) during initial treatment with erenumab. Treatment interruption was associated with a temporary worsening of condition. Symptoms ameliorated upon therapy reuptake reaching improvements similar to pre-break within 3 months.

Conclusions: Treatment interruption was associated with a temporary worsening of condition, which improved again after therapy restart.

Keywords: Break; CGRP; Erenumab; Migraine; RWE; Real world evidence.

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Conflict of interest statement

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: ARG reports honorarium and/or consulting fees from Allergan, Almirall, Amgen, Curatis, Eli Lilly, Grünenthal, Lundbeck, Novartis and TEVA Pharmaceuticals. RA report honoraria for speaker, advisory board and/or investigator activities from Allergan, Almogran, Drossa Pharma, Eli Lilly, Lundbeck, Medical Tribune (Biomed, Schwabe), Merz, Novartis and TEVA. CPK has received honoraria for lectures as well as research support from Almirall, Biogen, Celgene, Eli Lilly, Janssen, Merck, Novartis, Roche, Sanofi Genzyme, Swiss MS Society (SMSG) and Teva. GSM-F reports honoraria for advisor and speaker activities from Novartis. HP received honoraria from Eli Lilly, speaker fees from Novartis and TEVA Pharmaceuticals as well as fundings from the Werner Dessauer Stiftung. PR's institution has received fees for his participation to advisory boards or speaker fees from Eli-Lilly, Lundbeck Novartis, and Teva pharmaceuticals. CJS received consulting, advisory boards and speaker fees as well as travel support from Abbvie, Allergan, Almirall, Amgen, Eli Lilly, Grünenthal, Lundbeck, MindMed, Novartis, TEVA Pharmaceuticals; part-time-employee at Zynnon, and has received funding from TEVA Pharmaceuticals, Baasch-Medicus Foundation Deutsche Migräne- und Kopfschmerzgesellschaft (www.dmkg.de) and Swiss Heart Foundation outside the submitted work. CB, DZ and NR declared no conflict of interests. CZ has received honoraria for advisory boards from the Swiss MS Society. Ente Ospedaliero Cantonale (employer) received compensation for C.Z.’s speaking activities, consulting fees, or research grants from Almirall, Biogen Idec, Bristol Meyer Squibb, Lundbeck, Merck, Novartis, Sanofi, Teva Pharma, Roche. CZ is recipient of a grant for senior researchers provided by AFRI (Area Formazione accademica, Ricerca ed Innovazione). ES, IM, MKS and MEA are employees of Novartis Pharma Schweiz AG or were employees of Novartis Pharma Schweiz AG during conduct of this study.

Figures

Fig. 1
Fig. 1
Impact of erenumab treatment on mean monthly migraine days (MMD) during the observational period of 18 months. MMD mean monthly migraine days; Gap therapy break; EM episodic migraine; CM chronic migraine; Total total study population; n number of patients; SD standard deviation
Fig. 2
Fig. 2
Impact of erenumab treatment on HIT-6™ during the observational period of 18 months. The full range of possible scores is shown, with 36 and 78 being the lowest- and highest-possible scores. HIT Headache Impact Test; EM episodic migraine; CM chronic migraine; Total total study population; n number of patients; SD standard deviation
Fig. 3
Fig. 3
Impact of erenumab treatment on IMPAC during the observational period of 18 months. IMPAC Impact of Migraine on Partners and Adolescent Children; EM episodic migraine; CM chronic migraine; Total total study population; n number of patients; SD standard deviation
Fig. 4
Fig. 4
Impact of erenumab treatment on mMIDAS during the observational period of 18 months. mMIDAS modified Migraine Disability Assessment; EM episodic migraine; CM chronic migraine; Total total study population; n number of patients; SD standard deviation
Figure 5:
Figure 5:
a Number of patients per group; b Impact of erenumab treatment break on MMD per group over 18 months. Group A (n = 14): > 0 to < 2.5 months break; Group B (n = 68): ≥ 2.5 to < 6 months break; Group C (n = 10): ≥ 6 months break (with a therapy restart); Group D (n = 17): no break; Group E (n = 63): no documented therapy re-initiation during observational period (therapy break/no reuptake data available). BL baseline; M month; MMD, mean monthly migraine days.
Fig. 6
Fig. 6
Effect of erenumab treatment on mean monthly migraine days (MMD) response rates. MMD mean monthly migraine days; n, number of patients
See this image and copyright information in PMC

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