A head‐to‐head observational cohort study on the efficacy and safety of monoclonal antibodies against calcitonin gene–related peptide for chronic and episodic migraine

Saccà, Francesco; Braca, Simone; Sansone, Mattia; Miele, A.; Stornaiuolo, Antonio; Simone, Roberto De; Russo, Cinzia Valeria

doi:10.1111/head.14528

Cited by 9 publications

(5 citation statements)

References 23 publications

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“…All three CGRP medications decreased MDM in responders with large effect sizes. This finding is consistent with clinical trials, systematic reviews, and meta‐analyses of clinical trials 29–33 and complements recent work 61,62 . At both follow‐ups, a higher baseline MDM was associated with a greater decrease in MDM at follow‐up and greater decreases in MDM at follow‐up were seen in females and in patients with longer duration of follow‐up.…”

Section: Discussionsupporting

confidence: 90%

“…This finding is consistent with clinical trials, systematic reviews, and meta-analyses of clinical trials [29][30][31][32][33] and complements recent work. 61,62 At both follow-ups, a higher baseline MDM was associated with a greater decrease in MDM at follow-up and greater decreases in MDM at follow-up were seen in females and in patients with longer duration of follow-up. Patients with a prior hospitalization for migraine and non-response to a greater number of previously tried preventives showed a smaller decrease in MDM at the first, but not the second, follow-up.…”

Section: Discussionmentioning

confidence: 95%

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Characteristics associated with response to subcutaneously administered anti‐CGRP monoclonal antibody medications in a real‐world community cohort of persons living with migraine: A retrospective clinical and genetic study

Chase,

Semenov,

Rubin

et al. 2023

Headache

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ObjectiveTo evaluate response to anti‐calcitonin gene–related peptide (CGRP) migraine preventives in a real‐world community cohort of persons living with migraine and to identify clinical and genetic characteristics associated with efficacious response.BackgroundErenumab‐aooeb, fremanezumab‐vrfm, and galcanezumab‐gnlm target CGRP or its receptor; however, many patients are non‐responsive.MethodsIn this retrospective clinical and genetic study, we identified 1077 adult patients who satisfied the International Classification of Headache Disorders, 3rd edition, criteria for migraine without aura, migraine with aura, or chronic migraine and who were prescribed an anti‐CGRP migraine preventive between May 2018 and May 2021. Screening of 558 patients identified 289 with data at baseline and first follow‐up visits; data were available for 161 patients at a second follow‐up visit. The primary outcome was migraine days per month (MDM). In 198 genotyped patients, we evaluated associations between responders (i.e., patients with ≥50% reduction in MDM at follow‐up) and genes involved in CGRP signaling or pharmacological response, and genetic and polygenic risk scores.ResultsThe median time to first follow‐up was 4.4 (0.9–22) months after preventive start. At the second follow‐up, 5.7 (0.9–13) months later, 145 patients had continued on the same preventive. Preventives had strong, persistent effects in reducing MDM in responders (follow‐up 1: η2 = 0.26, follow‐up 2: η2 = 0.22). At the first but not second follow‐up: galcanezumab had a larger effect than erenumab, while no difference was seen at either follow‐up between galcanezumab and fremanezumab or fremanezumab and erenumab. The decrease in MDM at follow‐up was generally proportional to baseline MDM, larger in females, and increased with months on medication. At the first follow‐up only, patients with prior hospitalization for migraine or who had not responded to more preventive regimens had a smaller decrease in MDM. Reasons for stopping or switching a preventive varied between medications and were often related to cost and insurance coverage. At both follow‐ups, patient tolerance (1: 92.2% [262/284]; 2: 95.2% [141/145]) and continued use (1: 77.5% [224/289]; 2: 80.6% [116/145]) were high and similar across preventives. Response consistency (always non‐responders: 31.7% [46/145]; always responders: 56.5% [82/145], and one‐time only responders: 11.7% [17/145]) was also similar across preventives. Non‐responder status had nominally significant associations with rs12615320‐G in RAMP1 (odds ratio [95% confidence interval]: 4.7 [1.5, 14.7]), and rs4680‐A in COMT (0.6[0.4, 0.9]). Non‐responders had a lower mean genetic risk score than responders (1.0 vs. 1.1; t(df) = −1.75(174.84), p = 0.041), and the fraction of responders increased with genetic and polygenic risk score percentile.ConclusionsIn this real‐world setting, anti‐CGRP preventives reduced MDM persistently and had similar and large effect sizes on MDM reduction; however, clinical and genetic factors influenced response.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 95%

Characteristics associated with response to subcutaneously administered anti‐CGRP monoclonal antibody medications in a real‐world community cohort of persons living with migraine: A retrospective clinical and genetic study

Chase,

Semenov,

Rubin

et al. 2023

Headache

View full text Add to dashboard Cite

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“…In a prospective study involving 140 migraineurs (45 treated with erenumab, 54 with fremanezumab, and 41 with galcanezumab), the authors reported no differences in migraine frequency, MIDAS, or symptomatic medication intake. Interestingly, fremanezumab and galcanezumab in chronic migraineurs with MOH were superior to erenumab [21].…”

Section: Discussionmentioning

confidence: 97%

Comparative Study of the Efficacy of Anti-CGRP mAbs on Migraineurs: Analysis of the First Year of Therapy, 1-Month Suspension Period, and Reprisal

Tereshko,

Dal Bello,

Pez

et al. 2023

JCM

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Background: Few studies compare the clinical effectiveness of the three anti-CGRP mAbs. Moreover, no studies compare their efficacy during suspension and reprisal. Our study aimed to compare the efficacy of migraine frequency, intensity, and symptomatic medication intake during the first year of therapy, a 1-month suspension period, and a 3-month drug reprisal. Methods: A total of 160 migraineurs (chronic and high-frequency episodic) were treated with anti-CGRP mAbs (49 with fremanezumab, 55 with erenumab, and 55 with galcanezumab) for 12 months. They discontinued the therapy for 1 month and then reprised the therapy. In the three groups, we analyzed and compared the migraine days per month, migraine intensity, and symptomatic medication intake per month at baseline, 3-month, 6-month, and 12-month follow-up. We also compared these variables during the 1-month suspension and 3 months after the reprisal of the therapy. We compared the data and evaluated the response rate (>50% reduction in migraine days per month) at different follow-ups. This comparison was also performed separately for chronic and high-frequency episodic migraineurs. Results: There was no statistical difference in monthly migraine days, intensity, or symptomatic medication intake per month at the different follow-ups. Moreover, there was no difference in the response rate overall. However, in chronic migraineurs treated with galcanezumab, the response rate was higher during the 1-month suspension when compared to fremanezumab and erenumab. In high-frequency episodic migraineurs, fremanezumab had a higher response rate at 12-month follow-up when compared to galcanezumab and erenumab. Conclusions: In our study, the three anti-CGRP mAbs presented a similar response, with no significant differences, during the first year of therapy, the suspension period, and 3 months after the drug reprisal. The response rate during the 1-month suspension period in chronic migraineurs may be higher with galcanezumab.

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“… 13 Other groups however, have reported lower rates. 15 The reason for such variability in continuation rates is not clear.…”

Section: Discussionmentioning

confidence: 99%

Twelve-month efficacy of CGRP monoclonal antibodies and predictive value of short-term response: results of an Australian multicentre study

Ray,

Dalic,

Baker

et al. 2024

BMJ Neurol Open

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IntroductionClinical trials show that calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are effective preventative treatments for chronic migraine. Their efficacy over longer time periods and in cohorts originally excluded from trials remains uncertain. This study aims to explore the impact of CGRP mAbs in an Australian real-life setting.MethodsA multicentre cohort study was performed in the tertiary headache clinics of the Alfred and Austin Hospitals, Melbourne, Australia. Patients were commenced on a CGRP mAb for chronic migraine and asked to keep a headache diary, recorded at 3 monthly appointments for 12 months. Primary outcome was a ≥50% reduction in monthly headache days (MHD).ResultsFrom a population of 105 patients, 90 patients commenced galcanezumab and 15 commenced fremanezumab. The ≥50% responder rate of the cohort was 52.4% after 3 months. Over 12 months follow-up, 25.7% of the cohort ceased due to a lack of efficacy and 16.2% ceased due to an adverse event. There was no difference in response or cessation between medications. There was poor agreement in 3-month and 12-month response rates (Cohen’s κ=0.130; p=0.171). On subgroup analysis, continuous headache at baseline and number of trialled preventative treatments were the only factors associated with efficacy.ConclusionCGRP mAbs were associated with sustained reductions in MHD over 12-month follow-up in patients with resistant migraine in Australia. Further studies are required to determine treatment options for patients with continuous headache. Poor agreement between outcomes at 3 and 12 months highlights the need to assess some patients at later timepoints.

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A head‐to‐head observational cohort study on the efficacy and safety of monoclonal antibodies against calcitonin gene–related peptide for chronic and episodic migraine

Cited by 9 publications

References 23 publications

Characteristics associated with response to subcutaneously administered anti‐CGRP monoclonal antibody medications in a real‐world community cohort of persons living with migraine: A retrospective clinical and genetic study

Characteristics associated with response to subcutaneously administered anti‐CGRP monoclonal antibody medications in a real‐world community cohort of persons living with migraine: A retrospective clinical and genetic study

Comparative Study of the Efficacy of Anti-CGRP mAbs on Migraineurs: Analysis of the First Year of Therapy, 1-Month Suspension Period, and Reprisal

Twelve-month efficacy of CGRP monoclonal antibodies and predictive value of short-term response: results of an Australian multicentre study

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