Efficacy and Contextual (Placebo) Effects of CGRP Antibodies for Migraine: Systematic Review and Meta‐analysis

Forbes, Raeburn B; McCarron, Mark O.; Cardwell, Christopher

doi:10.1111/head.13907

Cited by 35 publications

(23 citation statements)

References 47 publications

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“…A meta-analysis addressing the proportion contextual effect (PCE), i.e. the ratio between the reduction in monthly migraine days in the placebo and in the experimental group – which in this case were eptinezumab, erenumab, fremanezumab and galcanezumab – showed that 66–68% of the achieved was due to contextual factors, including placebo effect [ 187 ]. Such a value is slightly higher than that previously observed for valproate and propranolol (57–58%) [ 188 ].…”

Section: Migraine Management According To the Bps Modelmentioning

confidence: 99%

Applying a biopsychosocial model to migraine: rationale and clinical implications

et al. 2022

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Migraine is a complex condition in which genetic predisposition interacts with other biological and environmental factors determining its course. A hyperresponsive brain cortex, peripheral and central alterations in pain processing, and comorbidities play a role from an individual biological standpoint. Besides, dysfunctional psychological mechanisms, social and lifestyle factors may intervene and impact on the clinical phenotype of the disease, promote its transformation from episodic into chronic migraine and may increase migraine-related disability.Thus, given the multifactorial origin of the condition, the application of a biopsychosocial approach in the management of migraine could favor therapeutic success. While in chronic pain conditions the biopsychosocial approach is already a mainstay of treatment, in migraine the biomedical approach is still dominant. It is instead advisable to carefully consider the individual with migraine as a whole, in order to plan a tailored treatment. In this review, we first reported an analytical and critical discussion of the biological, psychological, and social factors involved in migraine. Then, we addressed the management implications of the application of a biopsychosocial model discussing how the integration between non-pharmacological management and conventional biomedical treatment may provide advantages to migraine care.

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Section: Migraine Management According To the Bps Modelmentioning

confidence: 99%

Applying a biopsychosocial model to migraine: rationale and clinical implications

et al. 2022

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“…From an average baseline of 16 monthly migraine days, eptinezumab-treated patients had approximately 8 fewer migraine days each month on average relative to baseline and approximately 2 days fewer relative to placebo. The placebo effect observed in PROMISE-2 may be due to the route of administration, frequency of on-site visits, patient expectations and beliefs, or other contextual factors [17][18][19][20]. Despite the placebo response, eptinezumab demonstrated statistically and nominally different improvements in migraine frequency across 24 weeks of treatment.…”

Section: Discussionmentioning

confidence: 99%

Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy–2) study

et al. 2020

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Background PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide–targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment. Methods Patients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32). Results A total of 1072 adults received treatment: eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366. The reduction in mean monthly migraine days observed during the first dosing interval (100 mg, − 7.7 days; 300 mg, − 8.2 days; placebo, − 5.6 days) was further decreased after an additional dose (100 mg, − 8.2 days; 300 mg, − 8.8 days; placebo, − 6.2 days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The ≥50% and ≥ 75% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (≥50% MRRs weeks 13–24: 100 mg, 61.0%; 300 mg, 64.0%; placebo, 44.0%; and ≥ 75% MRRs weeks 13–24: 100 mg, 39.3%; 300 mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events. Conclusion Eptinezumab 100 mg or 300 mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24 weeks and demonstrated an acceptable safety profile in patients with chronic migraine. Trial registration ClinicalTrials.gov (Identifier: NCT02974153). Registered November 23, 2016.

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“…However, even for those 4 prophylactic agents several possible biases were identified by previous meta-analyses [ 83 – 86 ]. Recent meta-analyses evaluating the efficacy of CGRP mAb on the other hand showed that the trial quality assessment was consistently more homogeneous with an overall low risk of bias [ 87 – 91 ].…”

Section: Discussionmentioning

confidence: 99%

CGRP monoclonal antibodies in migraine: an efficacy and tolerability comparison with standard prophylactic drugs

et al. 2021

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Background Several drugs are available for the preventive treatment of both episodic and chronic migraine. The choice of which therapy to initiate first, second, or third is not straightforward and is based on multiple factors, including general efficacy, tolerability, potential for serious adverse events, comorbid conditions, and costs. Recently, a new class of migraine preventive drugs was introduced, i.e. monoclonal antibodies against calcitonin gene-related peptide (CGRP) or its receptor. Methods The present article summarizes the evidence gathered with this new migraine preventive drug class from randomized placebo-controlled clinical trials. It further puts this into perspective next to the evidence gained by the most widely used agents for the prevention of episodic and chronic migraine with an emphasis on efficacy and the robustness with which this efficacy signal was obtained. Results Although being a relatively new class of migraine preventive drugs, monoclonal antibodies blocking the CGRP pathway have an efficacy which is at least comparable if not higher than those of the currently used preventive drugs. Moreover, the robustness of this efficacy signal is substantiated by several randomized clinical trials each including large numbers of patients. In addition, because of their excellent tolerability and with long-term safety data emerging, they seem to have an unprecedented efficacy over adverse effect profile, clearly resulting in an added value for migraine prevention. Conclusions Balancing the data presented in the current manuscript with additional data concerning long term safety on the one hand and cost issues on the other hand, can be of particular use to health policy makers to implement this new drug class in the prevention of migraine.

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Efficacy and Contextual (Placebo) Effects of CGRP Antibodies for Migraine: Systematic Review and Meta‐analysis

Cited by 35 publications

References 47 publications

Applying a biopsychosocial model to migraine: rationale and clinical implications

Applying a biopsychosocial model to migraine: rationale and clinical implications

Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy–2) study

CGRP monoclonal antibodies in migraine: an efficacy and tolerability comparison with standard prophylactic drugs

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