Non‐Responders to Treatment With Antibodies to the CGRP‐Receptor May Profit From a Switch of Antibody Class

Ziegeler, Christian; May, Arne

doi:10.1111/head.13729

Cited by 49 publications

(35 citation statements)

References 3 publications

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“…These results suggest that fremanezumab is effective and well tolerated in patients with migraine who had failed a different CGRP pathway–targeted mAb and therefore that treatment failure to 1 CGRP pathway–targeted mAb does not predict treatment failure to another. This finding supports previous evidence showing that patients who had prior failure of a CGRP pathway–targeted mAb treatment achieved a clinical benefit by switching to another CGRP pathway–targeted mAb [ 34 – 36 ]. In a previous retrospective cohort study by Overeem and colleagues that included 25 patients who did not respond to erenumab and switched to either galcanezumab or fremanezumab, MHD were significantly reduced by Month 3 after switching and approximately 12% of patients achieved a ≥ 50% reduction in MHD [ 36 ].…”

Section: Discussionsupporting

confidence: 91%

Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine

et al. 2022

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Background Fremanezumab, a fully humanized monoclonal antibody (mAb; IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for the preventive treatment of migraine in adults. The efficacy and safety of fremanezumab for migraine prevention have been demonstrated in randomized, double-blind, placebo-controlled trials. Real-world effectiveness data are needed to complement clinical trial data. This study assessed the effectiveness of fremanezumab across different subgroups of adult patients with episodic migraine (EM), chronic migraine (CM), or difficult-to-treat (DTT) migraine in real-world clinical settings. Methods This retrospective, panel-based online chart review used electronic case report forms. Patient inclusion criteria were a physician diagnosis of EM or CM; age ≥ 18 years at the time of first fremanezumab initiation; ≥ 1 dose of fremanezumab treatment; ≥ 1 follow-up visit since first initiation; and ≥ 2 measurements of monthly migraine days (MMD; with 1 within a month before or at first initiation and ≥ 1 after first initiation). Changes in MMD and monthly headache days were assessed during the follow-up period. These endpoints were evaluated in subgroups of patients by migraine type (EM/CM) and in subgroups with DTT migraine (diagnosis of medication overuse [MO], major depressive disorder [MDD], generalized anxiety disorder [GAD], or prior exposure to a different CGRP pathway–targeted mAb [CGRP mAb]). Results Data were collected from 421 clinicians and 1003 patients. Mean (percent) reductions from baseline in MMD at Month 6 were − 7.7 (77.0%) in EM patients, − 10.1 (68.7%) in CM patients, − 10.8 (80.6%) in the MO subgroup, − 9.9 (68.3%) in the MDD subgroup, − 9.5 (66.4%) in the GAD subgroup, and − 9.0 (68.7%) in the prior CGRP mAb exposure subgroup. Improvements in MDD or GAD severity were reported by 45.5% and 45.8% of patients with comorbid MDD or GAD, respectively. Conclusions In this real-world study, fremanezumab demonstrated effectiveness for migraine regardless of migraine type or the presence of factors contributing to DTT migraine (MO, GAD, MDD, or prior exposure to a different CGRP mAb).

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Section: Discussionsupporting

confidence: 91%

Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine

et al. 2022

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“…Because of the different targets of the two CGRP-mAb classes (ligand vs. receptor), it is conceivable that patients who did not respond to one CGRP-mAb class may benefit from a switch to the other class. Clinical observations support this hypothesis: one small case series reported three patients who did not respond to treatment with erenumab showed a substantial reduction of headache days after a switch to galcanezumab ( 6 ). Other than this case report no clinical trial assessed the effect of the switch of non-responders from one CGRP-mAb class to the subsequent exposure of another CGRP-mAb.…”

Section: Introductionmentioning

confidence: 94%

Effect of antibody switch in non-responders to a CGRP receptor antibody treatment in migraine: A multi-center retrospective cohort study

Overeem

Peikert²,

Hofacker

et al. 2021

Cephalalgia

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Background Switching between antibody classes might be a treatment option in migraine patients who have not responded to one class of a CGRP-(receptor) monoclonal antibody (mAb), but there are no efficacy data so far. In this real-world analysis, we assessed the treatment response to a CGRP-mAb in patients that have previously failed the CGRP-receptor-mAb erenumab. Methods We analyzed retrospective headache diary data of 78 patients with migraine who switched between CGRP-mAbs classes at four German headache centers either due to lack of efficacy or intolerable side effects. Among these, we identified 25 patients who did not respond to erenumab after three treatment cycles (defined as <30% reduction of monthly headache days) and had complete headache documentation at least one month before and during both treatments. We assessed the ≥30% responder rate at month three after switching from erenumab to a CGRP-mAb (galcanezumab or fremanezumab) (primary endpoint). Secondary endpoints included ≥50% responder rate, monthly headache days, and monthly days with acute medication use. In an exploratory subgroup analysis patients were stratified for daily and non-daily headache. Results The switch from erenumab to a CGRP-mAb led to a ≥30% response in one-third (32%) of the patients after three treatment cycles. A ≥50% response was achieved in 12% of the patients. Monthly headache days were reduced in month three compared to baseline (20.8 ± 7.1 to 17.8 ± 9.1; p = 0.009). Stratified analysis revealed that no patient with daily headache (n = 9) responded to the treatment switch, while a 30% response was achieved by 50% of patients with non-daily headache (n = 16). Conclusion Our findings demonstrate that a relevant proportion of erenumab non-responders might benefit from a treatment switch to a CGRP-mAb. Switching seems to be a promising treatment option especially in migraine patients with non-daily headache.

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“…Conversely, few data are available on the efficacy of antibody switch from erenumab to galcanezumab or fremanezumab in patients with a poor response to erenumab. 90 , 91 A retrospective case series allowed antibody switch after 3 erenumab administrations in those with a <30% response rate and showed that 32% patients achieved the >30% response rate and 12% the 50% response rate. Patients also reported a significant reduction in median MHDs but no in AMDs.…”

Section: Future Treatment Perspectivesmentioning

confidence: 99%

Migraine Prevention with Erenumab: Focus on Patient Selection, Perspectives and Outcomes

Sacco¹,

Ornello²

2022

TCRM

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Erenumab is a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor suitable for episodic and chronic migraine prevention. Randomized clinical trials proved the superiority of erenumab to placebo in a strictly selected population, while real-world studies confirmed treatment efficacy in more severe forms of disease – most patients suffered from chronic migraine with medication overuse headache, had prior treatment failures, and long disease duration. According to guidelines, anti-CGRP pathway monoclonal antibodies should be reserved to patients who failed or have contraindication to several classes of preventive treatments. However, their ease of use, tolerability and efficacy make these monoclonal antibodies ideally suitable for most patients with migraine; cost-effectiveness needs to be considered when looking at expanding current prescription criteria. Also, data from open label extensions of randomized control trials confirmed sustained benefits of prolonged treatment up to 5 consecutive years without significant risk of adverse events. Further studies will provide insights on optimal treatment duration to achieve migraine remission and predictors of treatment response. In the present work, we aimed at reviewing design and results of the main studies on erenumab and discussing treatment use in the current migraine prevention scenario; we also summarized the main ongoing research projects and provided clinical perspectives for the future.

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Non‐Responders to Treatment With Antibodies to the CGRP‐Receptor May Profit From a Switch of Antibody Class

Cited by 49 publications

References 3 publications

Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine

Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine

Effect of antibody switch in non-responders to a CGRP receptor antibody treatment in migraine: A multi-center retrospective cohort study

Migraine Prevention with Erenumab: Focus on Patient Selection, Perspectives and Outcomes

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