Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2022 Nov 18;23(1):142.
doi: 10.1186/s10194-022-01515-8.

Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results

Andreas R Gantenbein  1 , Reto Agosti  2 , Christian P Kamm  3   4 , Gunther Landmann  5 , Niklaus Meier  6 , Gabriele Susanne Merki-Feld  7 , Jens A Petersen  8 , Heiko Pohl  9 , Philippe Ryvlin  10 , Christoph J Schankin  3 , Dragana Viceic  11 , Chiara Zecca  12   13 , Elisabeth Schäfer  14 , Ina Meyer  14 , Michael E Arzt  14
Affiliations
Observational Study

Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results

Andreas R Gantenbein et al. J Headache Pain. .

Erratum in

Abstract

Background: The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting.

Methods: An interim analysis was conducted after all patients completed 6 months of erenumab treatment. Patients kept a headache diary and completed questionnaires at follow up visits. The overall study duration comprises 24 months.

Results: In total, 172 adults with chronic or episodic migraine from 19 different sites across Switzerland were enrolled to receive erenumab every 4 weeks. At baseline, patients had 16.6 ± 7.2 monthly migraine days (MMD) and 11.6 ± 7.0 acute migraine-specific medication days per month. After 6 months, erenumab treatment reduced Headache Impact Test (HIT-6™) scores by 7.7 ± 8.4 (p < 0.001), the modified Migraine Disability Assessment (mMIDAS) by 14.1 ± 17.8 (p < 0.001), MMD by 7.6 ± 7.0 (p < 0.001) and acute migraine-specific medication days per month by 6.6 ± 5.4 (p < 0.001). Erenumab also reduced the impact of migraine on social and family life, as evidenced by a reduction of Impact of Migraine on Partners and Adolescent Children (IMPAC) scores by 6.1 ± 6.7 (p < 0.001). Patients reported a mean effectiveness of 67.1, convenience of 82.4 and global satisfaction of 72.4 in the Treatment Satisfaction Questionnaire for Medication (TSQM-9). In total, 99 adverse events (AE) and 12 serious adverse events (SAE) were observed in 62 and 11 patients, respectively. All SAE were regarded as not related to the study medication.

Conclusions: Overall quality of life improved and treatment satisfaction was rated high with erenumab treatment in real-world clinical practice. In addition, the reported impact of migraine on spouses and children of patients was reduced.

Trial registration: BASEC ID 2018-02,375 in the Register of All Projects in Switzerland (RAPS).

Keywords: Erenumab; Healthcare impact; Migraine; Quality of life; Real-world evidence; Switzerland.

PubMed Disclaimer

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. GL reports honorarium and/or consulting fees from Almirall, Eli Lilly, Grünenthal, Novartis and Pfizer. NM reports honorarium for his participation to an advisory board from Novartis. GSM 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 Allergan, Almirall, Amgen, Eli Lilly, Grünenthal, Lundbeck, MindMed, Novartis, TEVA Pharmaceuticals; part-time-employee at Zynnon, and has received funding from Baasch-Medicus Foundation Deutsche Migräne- und Kopfschmerzgesellschaft (www.dmkg.de) and Swiss Heart Foundation outside the submitted work. JAP declared no conflict of interests. DV received financial support for consultancies and research from Eli Lilly, Novartis and Teva Pharma. 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 reseachers provided by AFRI (Area Formazione accademica, Ricerca ed Innovazione). ES, IM, and MEA are employees of Novartis Pharma Schweiz AG.

Figures

Fig. 1
Fig. 1
Study design and visit schedule. mo: month; V: visit
Fig. 2
Fig. 2
HIT-6™ reduction after 6 months per migraine type (N = 159). The full range of HIT-6™ possible scores is shown, with 36 being the lowest-possible score and 78 the highest-possible score. Abbreviations: EM: episodic migraine; CM: chronic migraine; HIT-6.™: Headache Impact Test-6
Fig. 3
Fig. 3
Mean mMIDAS score at baseline and after 6 months per migraine type (N = 151). Abbreviations: EM: episodic migraine; CM: chronic migraine; mMIDAS: modified migraine disability assessment
Fig. 4
Fig. 4
IMPAC grades at baseline (N = 162) and month 6 (N = 147)
Fig. 5
Fig. 5
Response rates after 6 month per migraine type (N = 158). Abbreviations: MMD: monthly migraine days; EM: episodic migraine; CM: chronic migraine
See this image and copyright information in PMC

References

    1. Weatherall MW. The diagnosis and treatment of chronic migraine. Ther Adv Chronic Dis. 2015;6(3):115–123. doi: 10.1177/2040622315579627. - DOI - PMC - PubMed
    1. Serrano D, Lipton RB, Scher AI, Reed ML, Stewart W, Adams AM, Buse DC. Fluctuations in episodic and chronic migraine status over the course of 1 year: implications for diagnosis, treatment and clinical trial design. J Headache Pain. 2017;18(1):101. doi: 10.1186/s10194-017-0787-1. - DOI - PMC - PubMed
    1. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. (2018). Cephalalgia 38(1):1–211. 10.1177/0333102417738202 - PubMed
    1. Vo P, Paris N, Bilitou A, Valena T, Fang J, Naujoks C, Cameron A, de Reydet de Vulpillieres F. Cadiou F. Burden of Migraine in Europe Using Self-Reported Digital Diary Data from the Migraine Buddy© Application. Neurol Ther. 2018;7(2):321–332. doi: 10.1007/s40120-018-0113-0. - DOI - PMC - PubMed
    1. Steiner TJ, Stovner LJ, Katsarava Z, Lainez JM, Lampl C, Lantéri-Minet M, Rastenyte D, Ruiz de la Torre E, Tassorelli C, Barré J, Andrée C. The impact of headache in Europe: principal results of the Eurolight project. J Headache Pain. 2014;15(1):31. doi: 10.1186/1129-2377-15-31. - DOI - PMC - PubMed

Publication types

Substances