Clinical evaluation of super-responders vs. non-responders to CGRP(-receptor) monoclonal antibodies: a real-world experience

Raffaelli, Bianca; Fitzek, Mira Pauline; Overeem, Lucas Hendrik; Storch, Elisabeth; Terhart, Maria; Reuter, Uwe

doi:10.1186/s10194-023-01552-x

Cited by 35 publications

(40 citation statements)

References 58 publications

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“…Older age, lower MMDs and fewer previous treatment failures were also associated with >50% responders at three months in a real-world study (19). Similar to previous studies, unilateral localization, pulsatile nature (18,22), less comorbid MOH (22), fewer prophylactics used previously, and fewer baseline MMDs (19) were related to responders in our study. Regarding the effect of aura on clinical efficacy, in logistic regression analysis, the presence of aura did not remain a predictor of responders, but it was associated with ≥50% responders at six and 12 months.…”

Section: Discussionsupporting

confidence: 89%

“…In a multicenter study consisting of 864 patients with high-frequency EM or CM who received three types of CGRP mAbs for six months, it was found that the presence of unilateral pain, unilateral cranial autonomic symptoms and allodynia were predictors of responders (18). In a study of 260 patients with migraine receiving CGRP mAbs, typical migraine characteristics such as unilateral localization, pulsating character, photophobia or nausea were associated with ≥75% responders at three months, while CM, MOH, and concomitant depression were related to nonresponders (22). Older age, lower MMDs and fewer previous treatment failures were also associated with >50% responders at three months in a real-world study (19).…”

Section: Discussionmentioning

confidence: 99%

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Effectiveness of three calcitonin gene-related peptide monoclonal antibodies for migraine: A 12-month, single-center, observational real-world study in Japan

Suzuki

Shiina

et al. 2023

Cephalalgia

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Background Real-world data on the effectiveness of calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) in migraine patients are needed. Methods We performed a single-center, real-world study with an observation period of up to 12 months (mean 7.5 ± 3.4 months) after CGRP mAb administration. A total of 228 Japanese patients with episodic or chronic migraine (age, 45.9 ± 13.2 years; 184F; 45 erenumab; 60 galcanezumab; 123 fremanezumab) who were treated with CGRP mAbs for at least three months were ultimately included in this study. Results In the total cohort, after CGRP mAb treatment, mean monthly migraine days decreased by 7.2 ± 4.8, 8.3 ± 4.7, and 9.5 ± 5.0 at three, six and 12 months, respectively. The ≥50% monthly migraine day reduction rates at three, six and 12 months were 48.2%, 61.0% and 73.7%, respectively. In the logistic regression analysis, the presence of osmophobia and fewer baseline monthly migraine days contributed to ≥50% responders at three, six and 12 months. The ≥50% responders at three or six months were useful in predicting ≥50% responders at 12 months. In subgroups of patients with difficult-to-treat migraine (those with medication overuse headache or psychiatric comorbidities) and previous CGRP mAb users, monthly migraine days were substantially reduced over 12 months. There was no difference in monthly migraine day reduction over 12 months among three different CGRP mAbs. Adverse reactions were observed in 28 (12.3%) patients, with injection site reactions being the most common (n = 22) though generally mild in severity. Conclusion This real-world study confirmed the efficacy and safety of three different CGRP mAbs for prophylactic treatment of patients with migraine.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Effectiveness of three calcitonin gene-related peptide monoclonal antibodies for migraine: A 12-month, single-center, observational real-world study in Japan

Suzuki

Shiina

et al. 2023

Cephalalgia

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“…Among participants with chronic migraine, a positive effect of cabergoline was less obvious, which may relate to inadequate study power or a true lack of treatment efficacy in these participants. Our study population comprised only 13 participants with chronic migraine, which is particularly noteworthy since this group commonly exhibits a lower treatment response 20 also to CGRP-targeting therapies 21 . Migraine trials are characterized by a substantial placebo effect 22 and the larger placebo response in participants with chronic migraine in our study may accordingly be explained by a combination of more severe symptoms and a higher expectation of pain relief 23 .…”

Section: Discussionmentioning

confidence: 99%

Cabergoline as a Preventive Migraine Treatment: An Investigator-Initiated Randomized Controlled Trial

Hjelholt,

Bach,

Kasch

et al. 2023

Preprint

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BackgroundBeneficial effects of dopamine agonist treatment on migraine have been reported but remain to be properly tested.Aimto examine the effect of cabergoline as preventive treatment for migraine.Primary endpointChange in monthly migraine days (MMD).MethodsIn a randomized, double-blind, placebo-controlled pilot study, 36 adults with episodic and chronic migraine were enrolled. Following a 28-days baseline period, participants received cabergoline 0.5 mg or placebo once weekly for 12 weeks as add-on treatment. An electronic headache diary was completed by the participant, and pertinent headache questionnaires and blood tests were collected at baseline and following the treatment period. The trial was registered withClinicalTrials.gov(NCT05525611).FindingsMean (SD) baseline MMD was 13.6 (4.1) in the cabergoline group and 14.0 (5.3) in the placebo group. In participants with episodic migraine (n= 20), the change in mean MMD (SE) from baseline to the last 28 days of the treatment period was -5.4 (1.3) (cabergoline) as compared to -1.8 (0.9) (placebo) [odds ratio: 0.79 (95% CI 0.65 - 0.95), p=0.014]. In participants with chronic migraine (n=13), the reduction in MMD with cabergoline was not significant (p=0.6). Patients’ global impression of change significantly improved after cabergoline as compared to placebo in the entire group of participants (p=0.006). The number of participants with episodic migraine achieving ≥ 50% reduction in MMD tended to increase after cabergoline (p=0.07). Seven participants receiving cabergoline and 4 participants receiving placebo experienced adverse effects, none of which were serious.InterpretationsPreventive cabergoline treatment exhibited clinically meaningful improvement in episodic migraine without serious adverse effects. This provides proof-of-concept to justify a sufficiently powered phase 2 trial with different cabergoline dosing regimens as preventive treatment of episodic migraine.FundingThis study has received no external funding.

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“…Real-world data on the monoclonal antibody galcanezumab also demonstrate similar results, indicating that the responder group had fewer headache days compared to the non-responder group (24.0 ± 6.4 vs. 26.0 ± 6.2, p ≤ 0.012) (129). When focusing on the comparison between CM and EM, a recent study comparing super responders (SR) and non-responders (NR) found that the percentage of CM in the NR group was higher than in the SR group (92% vs. 52%, p = 0.001) (130). However, in another real-world study using erenumab, it was found that fewer headache days were a good predictor only in the CM group and not in the EM group (131).…”

Section: Anti-cgrp Medication and Medication Underusementioning

confidence: 99%

Medication “underuse” headache

Rattanawong,

Rapoport,

Srikiatkhachorn

2024

Cephalalgia

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Background Many risk factors have been associated with migraine progression, including insufficient and ineffective utilization of migraine medications; however, they have been inadequately explored. This has resulted in suboptimal usage of medications without effective altering of prescribing recommendations for patients, posing a risk for migraine chronification. Methods Our aim is to conduct a comprehensive review of the available evidence regarding the underuse of migraine medications, both acute and preventive. The term “underuse” includes, but is not limited to: ( 1 ) ineffective use of appropriate and inappropriate medication; ( 2 ) underutilization; ( 3 ) inappropriate timing of usage; and ( 4 ) patient dissatisfaction with medication. Results The underuse of both acute and preventive medications has been shown to contribute to the progression of migraine. In terms of acute medication, chronification occurs as a result of insufficient drug use, including failure of the prescriber to select the appropriate type based on pain intensity and disability, patients taking medication too late (more than 60 minutes after the onset or after central sensitization has occurred as evidenced by allodynia), and discontinuation because of lack of effect or intolerable side effects. The underlying cause of inadequate effectiveness of acute medication lies in its inability to halt the propagation of peripheral activation to central sensitization in a timely manner. For oral and injectable preventive migraine medications, insufficient efficacy and intolerable side effects have led to poor adherence and discontinuation with subsequent progression of migraine. The underlying pathophysiology here is rooted in the repetitive stimulation of afferent sensory pain fibers, followed by ascending brainstem pain pathways plus dysfunction of the endogenous descending brainstem pain inhibitory pathway. Although anti-calcitonin gene-related peptide (CGRP) medications partially address pain caused by the above factors, including decreased efficacy and tolerability from conventional therapy, some patients do not respond well to this treatment. Research suggests that initiating preventive anti-CGRP treatment at an early stage (during low frequency episodic migraine attacks) is more beneficial than commencing it during high frequency episodic attacks or when chronic migraine has begun. Conclusions The term “medication underuse” is underrecognized, but it holds significant importance. Optimal usage of acute care and preventive migraine medications could potentially prevent migraine chronification and improve the treatment of migraine attacks.

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Clinical evaluation of super-responders vs. non-responders to CGRP(-receptor) monoclonal antibodies: a real-world experience

Cited by 35 publications

References 58 publications

Effectiveness of three calcitonin gene-related peptide monoclonal antibodies for migraine: A 12-month, single-center, observational real-world study in Japan

Effectiveness of three calcitonin gene-related peptide monoclonal antibodies for migraine: A 12-month, single-center, observational real-world study in Japan

Cabergoline as a Preventive Migraine Treatment: An Investigator-Initiated Randomized Controlled Trial

Medication “underuse” headache

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