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Published in: The Journal of Headache and Pain 1/2023

Open Access 01-12-2023 | Migraine | Research

Predicting response to CGRP-monoclonal antibodies in patients with migraine in Japan: a single-centre retrospective observational study

Authors: Keiko Ihara, Seiya Ohtani, Narumi Watanabe, Nobuyuki Takahashi, Naoki Miyazaki, Kei Ishizuchi, Satoko Hori, Ryo Takemura, Jin Nakahara, Tsubasa Takizawa

Published in: The Journal of Headache and Pain | Issue 1/2023

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Abstract

Background

Anti-calcitonin gene-related peptide monoclonal antibodies (CGRPmAbs) are a favourable option for patients with migraine who experience distressful headache disability and fail to respond to traditional preventive treatment options. However, since CGRPmAb has been available for only 2 years in Japan, the difference between good and poor responders remains unknown. We aimed to investigate the clinical characteristics of patients with migraine in Japan who responded well to CGRPmAb based on real-world data.

Methods

We analysed patients who visited Keio University Hospital, Tokyo, Japan, between the 12th of August 2021 and 31st of August 2022, and were prescribed one of three CGRPmAbs (erenumab, galcanezumab, and fremanezumab) for more than 3 months. We recorded the patients’ basic migraine characteristics, such as pain quality, monthly migraine days (MMD)/monthly headache days (MHD), and the number of prior treatment failures. We defined good responders as patients whose MMDs decreased by more than 50% after 3 months of treatment and other patients as poor responders. We compared the baseline migraine characteristics between the two groups and performed logistic regression analysis based on the items that showed statistically significant differences.

Results

In total, 101 patients were considered eligible for the responder analysis (galcanezumab: 57 (56%), fremanezumab: 31 (31%), and erenumab: 13 (13%)). After 3 months of treatment, 55 (54%) patients achieved ≥ 50% reduction in MMDs. Comparisons between ≥ 50% responders and non-responders revealed that age was significantly higher (p = 0.003), and MHD and total prior treatment failures were significantly lower (p = 0.027, 0.040, respectively), in responders than in non-responders. Age was a positive predictive factor, and the total number of prior treatment failures and past medical history of immuno-rheumatologic diseases were negative predictive factors of CGRPmAb responsiveness in Japanese patients with migraine.

Conclusions

Patients with migraine who are older, with fewer prior treatment failures and no past history of immuno-rheumatologic disease, may respond well to CGRPmAbs.
Literature
1.
go back to reference GBD (2016) Headache Collaborators (2018) Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 17:954–976 GBD (2016) Headache Collaborators (2018) Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 17:954–976
2.
go back to reference Sakai F, Igarashi H (1997) Prevalence of migraine in Japan: a nationwide survey. Cephalalgia 17:15–22CrossRefPubMed Sakai F, Igarashi H (1997) Prevalence of migraine in Japan: a nationwide survey. Cephalalgia 17:15–22CrossRefPubMed
3.
go back to reference Sakai F, Ozeki A, Skljarevski V. Efficacy and safety of galcanezumab for prevention of migraine headache in Japanese patients with episodic migraine: A phase 2 randomized controlled clinical trial. Cephalalgia Reports. 2020;3 Sakai F, Ozeki A, Skljarevski V. Efficacy and safety of galcanezumab for prevention of migraine headache in Japanese patients with episodic migraine: A phase 2 randomized controlled clinical trial. Cephalalgia Reports. 2020;3
4.
go back to reference Sakai F, Suzuki N, Kim BK, Tatsuoka Y, Imai N, Ning X, Ishida M, Nagano K, Iba K, Kondo H et al (2021) Efficacy and safety of fremanezumab for episodic migraine prevention: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache 61:1102–1111CrossRefPubMedPubMedCentral Sakai F, Suzuki N, Kim BK, Tatsuoka Y, Imai N, Ning X, Ishida M, Nagano K, Iba K, Kondo H et al (2021) Efficacy and safety of fremanezumab for episodic migraine prevention: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache 61:1102–1111CrossRefPubMedPubMedCentral
5.
go back to reference Takeshima T, Sakai F, Hirata K, Imai N, Matsumori Y, Yoshida R, Peng C, Cheng S, Mikol DD (2021) Erenumab treatment for migraine prevention in Japanese patients: Efficacy and safety results from a Phase 3, randomized, double-blind, placebo-controlled study. Headache 61:927–935CrossRefPubMedPubMedCentral Takeshima T, Sakai F, Hirata K, Imai N, Matsumori Y, Yoshida R, Peng C, Cheng S, Mikol DD (2021) Erenumab treatment for migraine prevention in Japanese patients: Efficacy and safety results from a Phase 3, randomized, double-blind, placebo-controlled study. Headache 61:927–935CrossRefPubMedPubMedCentral
6.
go back to reference Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY (2018) Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia 38:1442–1454CrossRefPubMed Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY (2018) Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia 38:1442–1454CrossRefPubMed
7.
go back to reference Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA (2017) A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med 377:2123–2132CrossRefPubMed Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA (2017) A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med 377:2123–2132CrossRefPubMed
8.
go back to reference Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E (2018) Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA 319:1999–2008CrossRefPubMed Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E (2018) Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA 319:1999–2008CrossRefPubMed
9.
go back to reference Reuter U, Ehrlich M, Gendolla A, Heinze A, Klatt J, Wen S, Hours-Zesiger P, Nickisch J, Sieder C, Hentschke C et al (2022) Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia 42:108–118CrossRefPubMed Reuter U, Ehrlich M, Gendolla A, Heinze A, Klatt J, Wen S, Hours-Zesiger P, Nickisch J, Sieder C, Hentschke C et al (2022) Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia 42:108–118CrossRefPubMed
10.
go back to reference Takizawa T, Ohtani S, Watanabe N, Miyazaki N, Ishizuchi K, Sekiguchi K, Iba C, Shibata M, Takemura R, Hori S et al (2022) Real-world evidence of galcanezumab for migraine treatment in Japan: a retrospective analysis. BMC Neurol 22:512CrossRefPubMedPubMedCentral Takizawa T, Ohtani S, Watanabe N, Miyazaki N, Ishizuchi K, Sekiguchi K, Iba C, Shibata M, Takemura R, Hori S et al (2022) Real-world evidence of galcanezumab for migraine treatment in Japan: a retrospective analysis. BMC Neurol 22:512CrossRefPubMedPubMedCentral
11.
12.
go back to reference Zecca C, Cargnin S, Schankin C, Giannantoni NM, Viana M, Maraffi I, Riccitelli GC, Sihabdeen S, Terrazzino S, Gobbi C (2022) Clinic and genetic predictors in response to erenumab. Eur J Neurol 29:1209–1217CrossRefPubMedPubMedCentral Zecca C, Cargnin S, Schankin C, Giannantoni NM, Viana M, Maraffi I, Riccitelli GC, Sihabdeen S, Terrazzino S, Gobbi C (2022) Clinic and genetic predictors in response to erenumab. Eur J Neurol 29:1209–1217CrossRefPubMedPubMedCentral
13.
go back to reference Vernieri F, Altamura C, Brunelli N, Costa CM, Aurilia C, Egeo G, Fofi L, Favoni V, Lovati C, Bertuzzo D et al (2022) Rapid response to galcanezumab and predictive factors in chronic migraine patients: A 3-month observational, longitudinal, cohort, multicenter, Italian real-life study. Eur J Neurol 29:1198–1208CrossRefPubMed Vernieri F, Altamura C, Brunelli N, Costa CM, Aurilia C, Egeo G, Fofi L, Favoni V, Lovati C, Bertuzzo D et al (2022) Rapid response to galcanezumab and predictive factors in chronic migraine patients: A 3-month observational, longitudinal, cohort, multicenter, Italian real-life study. Eur J Neurol 29:1198–1208CrossRefPubMed
14.
go back to reference Barbanti P, Aurilia C, Egeo G, Fofi L, Cevoli S, Colombo B, Filippi M, Frediani F, Bono F, Grazzi L et al (2021) Erenumab in the prevention of high-frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real-life study. Headache 61:363–372CrossRefPubMed Barbanti P, Aurilia C, Egeo G, Fofi L, Cevoli S, Colombo B, Filippi M, Frediani F, Bono F, Grazzi L et al (2021) Erenumab in the prevention of high-frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real-life study. Headache 61:363–372CrossRefPubMed
15.
go back to reference Nowaczewska M, Straburzyński M, Waliszewska-Prosół M, Meder G, Janiak-Kiszka J, Kaźmierczak W (2022) Cerebral Blood Flow and Other Predictors of Responsiveness to Erenumab and Fremanezumab in Migraine-A Real-Life Study. Front Neurol 13:895476CrossRefPubMedPubMedCentral Nowaczewska M, Straburzyński M, Waliszewska-Prosół M, Meder G, Janiak-Kiszka J, Kaźmierczak W (2022) Cerebral Blood Flow and Other Predictors of Responsiveness to Erenumab and Fremanezumab in Migraine-A Real-Life Study. Front Neurol 13:895476CrossRefPubMedPubMedCentral
16.
go back to reference Frattale I, Caponnetto V, Casalena A, Assetta M, Maddestra M, Marzoli F, Affaitati G, Giamberardino MA, Viola S, Gabriele A et al (2021) Association between response to triptans and response to erenumab: real-life data. J Headache Pain 22:1CrossRefPubMedPubMedCentral Frattale I, Caponnetto V, Casalena A, Assetta M, Maddestra M, Marzoli F, Affaitati G, Giamberardino MA, Viola S, Gabriele A et al (2021) Association between response to triptans and response to erenumab: real-life data. J Headache Pain 22:1CrossRefPubMedPubMedCentral
17.
go back to reference Barbanti P, Egeo G, Aurilia C, d’Onofrio F, Albanese M, Cetta I, Di Fiore P, Zucco M, Filippi M, Bono F et al (2022) Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J Headache Pain 23:46CrossRefPubMedPubMedCentral Barbanti P, Egeo G, Aurilia C, d’Onofrio F, Albanese M, Cetta I, Di Fiore P, Zucco M, Filippi M, Bono F et al (2022) Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J Headache Pain 23:46CrossRefPubMedPubMedCentral
18.
go back to reference Iannone LF, Fattori D, Benemei S, Chiarugi A, Geppetti P, De Cesaris F (2022) Long-Term Effectiveness of Three Anti-CGRP Monoclonal Antibodies in Resistant Chronic Migraine Patients Based on the MIDAS score. CNS Drugs 36:191–202CrossRefPubMedPubMedCentral Iannone LF, Fattori D, Benemei S, Chiarugi A, Geppetti P, De Cesaris F (2022) Long-Term Effectiveness of Three Anti-CGRP Monoclonal Antibodies in Resistant Chronic Migraine Patients Based on the MIDAS score. CNS Drugs 36:191–202CrossRefPubMedPubMedCentral
19.
go back to reference Pensato U, Baraldi C, Favoni V, Cainazzo MM, Torelli P, Querzani P, Pascazio A, Mascarella D, Matteo E, Quintana S et al (2022) Real-life assessment of erenumab in refractory chronic migraine with medication overuse headache. Neurol Sci 43:1273–1280CrossRefPubMed Pensato U, Baraldi C, Favoni V, Cainazzo MM, Torelli P, Querzani P, Pascazio A, Mascarella D, Matteo E, Quintana S et al (2022) Real-life assessment of erenumab in refractory chronic migraine with medication overuse headache. Neurol Sci 43:1273–1280CrossRefPubMed
20.
go back to reference Bottiroli S, De Icco R, Vaghi G, Pazzi S, Guaschino E, Allena M, Ghiotto N, Martinelli D, Tassorelli C, Sances G (2021) Psychological predictors of negative treatment outcome with Erenumab in chronic migraine: data from an open label long-term prospective study. J Headache Pain 22:114CrossRefPubMed Bottiroli S, De Icco R, Vaghi G, Pazzi S, Guaschino E, Allena M, Ghiotto N, Martinelli D, Tassorelli C, Sances G (2021) Psychological predictors of negative treatment outcome with Erenumab in chronic migraine: data from an open label long-term prospective study. J Headache Pain 22:114CrossRefPubMed
21.
go back to reference Silvestro M, Tessitore A, Scotto di Clemente F, Battista G, Tedeschi G, Russo A (2021) Refractory migraine profile in CGRP-monoclonal antibodies scenario. Acta Neurol Scand 144:325–333CrossRefPubMedPubMedCentral Silvestro M, Tessitore A, Scotto di Clemente F, Battista G, Tedeschi G, Russo A (2021) Refractory migraine profile in CGRP-monoclonal antibodies scenario. Acta Neurol Scand 144:325–333CrossRefPubMedPubMedCentral
22.
go back to reference Wang SJ, Fuh JL, Young YH, Lu SR, Shia BC (2000) Prevalence of migraine in Taipei, Taiwan: a population-based survey. Cephalalgia 20:566–572CrossRefPubMed Wang SJ, Fuh JL, Young YH, Lu SR, Shia BC (2000) Prevalence of migraine in Taipei, Taiwan: a population-based survey. Cephalalgia 20:566–572CrossRefPubMed
23.
go back to reference Safiri S, Pourfathi H, Eagan A, Mansournia MA, Khodayari MT, Sullman MJM, Kaufman J, Collins G, Dai H, Bragazzi NL et al (2022) Global, regional, and national burden of migraine in 204 countries and territories, 1990 to 2019. Pain 163:e293–e309CrossRefPubMed Safiri S, Pourfathi H, Eagan A, Mansournia MA, Khodayari MT, Sullman MJM, Kaufman J, Collins G, Dai H, Bragazzi NL et al (2022) Global, regional, and national burden of migraine in 204 countries and territories, 1990 to 2019. Pain 163:e293–e309CrossRefPubMed
24.
go back to reference Song TJ, Cho SJ, Kim WJ, Yang KI, Yun CH, Chu MK (2019) Sex Differences in Prevalence, Symptoms, Impact, and Psychiatric Comorbidities in Migraine and Probable Migraine: A Population-Based Study. Headache 59:215–223CrossRefPubMed Song TJ, Cho SJ, Kim WJ, Yang KI, Yun CH, Chu MK (2019) Sex Differences in Prevalence, Symptoms, Impact, and Psychiatric Comorbidities in Migraine and Probable Migraine: A Population-Based Study. Headache 59:215–223CrossRefPubMed
25.
go back to reference Lance JW, Anthony M (1966) Some clinical aspects of migraine. A prospective survey of 500 patients. Arch Neurol 15:356–361CrossRefPubMed Lance JW, Anthony M (1966) Some clinical aspects of migraine. A prospective survey of 500 patients. Arch Neurol 15:356–361CrossRefPubMed
26.
go back to reference Kronenfeld LW, Reba-Harrelson L, Von Holle A, Reyes ML, Bulik CM (2010) Ethnic and racial differences in body size perception and satisfaction. Body Image 7:131–136CrossRefPubMedPubMedCentral Kronenfeld LW, Reba-Harrelson L, Von Holle A, Reyes ML, Bulik CM (2010) Ethnic and racial differences in body size perception and satisfaction. Body Image 7:131–136CrossRefPubMedPubMedCentral
27.
go back to reference Doi S, Ito M, Takebayashi Y, Muramatsu K, Horikoshi M (2018) Factorial Validity and Invariance of the 7-Item Generalized Anxiety Disorder Scale (GAD-7) Among Populations With and Without Self-Reported Psychiatric Diagnostic Status. Front Psychol 9:1741CrossRefPubMedPubMedCentral Doi S, Ito M, Takebayashi Y, Muramatsu K, Horikoshi M (2018) Factorial Validity and Invariance of the 7-Item Generalized Anxiety Disorder Scale (GAD-7) Among Populations With and Without Self-Reported Psychiatric Diagnostic Status. Front Psychol 9:1741CrossRefPubMedPubMedCentral
28.
go back to reference Muramatsu K, Seiryo N, Muramatsu Y, Miyaoka H, Fuse K, Yoshine F, Hosaka M, Katagiri A, Kutumi R (2009) Validation and utility of Japanese version of the GAD-7. PANMINERVA Medica. Abstracts Book, vol 51 20th World Congress on Psychosomatic Medicine, p 79 Muramatsu K, Seiryo N, Muramatsu Y, Miyaoka H, Fuse K, Yoshine F, Hosaka M, Katagiri A, Kutumi R (2009) Validation and utility of Japanese version of the GAD-7. PANMINERVA Medica. Abstracts Book, vol 51 20th World Congress on Psychosomatic Medicine, p 79
29.
go back to reference Muramatsu K, Miyaoka H, Kamijima K, Muramatsu Y, Tanaka Y, Hosaka M, Miwa Y, Fuse K, Yoshimine F, Mashima I et al (2018) Performance of the Japanese version of the Patient Health Questionnaire-9 (J-PHQ-9) for depression in primary care. Gen Hosp Psychiatry 52:64–69CrossRefPubMed Muramatsu K, Miyaoka H, Kamijima K, Muramatsu Y, Tanaka Y, Hosaka M, Miwa Y, Fuse K, Yoshimine F, Mashima I et al (2018) Performance of the Japanese version of the Patient Health Questionnaire-9 (J-PHQ-9) for depression in primary care. Gen Hosp Psychiatry 52:64–69CrossRefPubMed
30.
go back to reference Team RC (2016) R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria Team RC (2016) R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria
31.
go back to reference Kim YH, Lee JW, Kim Y, Bae JS, Kim YJ, Min C, Choi HG (2021) Bidirectional association between migraine and rheumatoid arthritis: two longitudinal follow-up studies with a national sample cohort. BMJ Open 11:e046283CrossRefPubMedPubMedCentral Kim YH, Lee JW, Kim Y, Bae JS, Kim YJ, Min C, Choi HG (2021) Bidirectional association between migraine and rheumatoid arthritis: two longitudinal follow-up studies with a national sample cohort. BMJ Open 11:e046283CrossRefPubMedPubMedCentral
32.
go back to reference Wang YC, Huang YP, Wang MT, Wang HI, Pan SL (2017) Increased risk of rheumatoid arthritis in patients with migraine: a population-based, propensity score-matched cohort study. Rheumatol Int 37:273–279CrossRefPubMed Wang YC, Huang YP, Wang MT, Wang HI, Pan SL (2017) Increased risk of rheumatoid arthritis in patients with migraine: a population-based, propensity score-matched cohort study. Rheumatol Int 37:273–279CrossRefPubMed
Metadata
Title
Predicting response to CGRP-monoclonal antibodies in patients with migraine in Japan: a single-centre retrospective observational study
Authors
Keiko Ihara
Seiya Ohtani
Narumi Watanabe
Nobuyuki Takahashi
Naoki Miyazaki
Kei Ishizuchi
Satoko Hori
Ryo Takemura
Jin Nakahara
Tsubasa Takizawa
Publication date
01-12-2023
Publisher
Springer Milan
Published in
The Journal of Headache and Pain / Issue 1/2023
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI
https://doi.org/10.1186/s10194-023-01556-7

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