Monoclonal antibodies against CGRP (R): non-responders and switchers: real world data from an austrian case series

Kaltseis, Katharina; Filippi, Vera; Frank, Florian; Eckhardt, C. C.; Schiefecker, Alois Josef; Broessner, Gregor

doi:10.1186/s12883-023-03203-9

Cited by 10 publications

(7 citation statements)

References 33 publications

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“…In a limited number of patients, a response was seen after switching from one ligand mAb to another, or even as a third mAb therapy, despite a previous class switch. However, these study groups were very small and it is not possible to generalise the results [ 19 , 20 ]. In our study, 20 patients had one ptCGRP and received either erenumab ( n = 10) or fremanezumab ( n = 5)/galcanezumab ( n = 5) prior to treatment with eptinezumab.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and tolerability of eptinezumab in treating patients with migraine resistant to conventional preventive medications and CGRP (receptor) antibodies: a multicentre retrospective real-world analysis from Germany

Scheffler,

Wenzel,

Bendig

et al. 2024

J Headache Pain

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Background Eptinezumab is a monoclonal antibody that targets calcitonin gene-related peptide (CGRP mAb) and is used for migraine prophylaxis. Efficacy data are mainly from clinical trials, real-world data are hardly available yet. Reimbursement policy in Germany leads to eptinezumab mainly being used in patients having failed pre-treatment with other CGRP mAb. To date, it is unclear whether eptinezumab is efficacious and well tolerated in this population and how the treatment response differs from patients who are naive to CGRP mAbs. Methods We analysed clinical routine data of 79 patients (episodic migraine (EM): n = 19; chronic migraine (CM): n = 60) from four different centres in Germany. All patients were treated with eptinezumab (100mg). Differences in monthly headache (MHD), migraine (MMD) and acute medication days (AMD) after three months were analysed. The correlation of response with the number of CGRP mAb failures was evaluated. Significance level has been corrected (alpha = 0.017). Results After three months MHD, MMD and AMD were significantly reduced. In EM, the median reduction for MHD was 4.0 days (IQR: -6.5 to -1.0; p = 0.001), for MMD 3.0 days (IQR: -5.5 to -1.5; p < 0.001) and for AMD 2.0 days (IQR: -5.0 to -0.5; p = 0.006). In CM, median reduction of MHD was 4 days (IQR: -8.0 to 0.0; p < 0.001), 3.0 days (IQR: -6.0 to-1.0; p < 0.001) for MMD and 1.0 day (IQR: -5.0 to 0.0; p < 0.001) for AMD. All patients were resistant to conventional preventive therapies and most to CGRP mAbs. Fourteen patients had never received a CGRP mAb and 65 patients had received at least one mAb without sufficient effectiveness and/or intolerability (one: n = 20, two: n = 28, three: n = 17). There was a significant association between the number of prior therapies and the 30% MHD responder rate (none: 78.6%, one: 45.0%, two: 32.1%, three: 23.5%, p = 0.010). Regarding tolerability, 10.4% (8/77) reported mild side effects. Conclusions The effectiveness of eptinezumab is significantly reduced in patients who have not previously responded to other CGRP mAbs. However, limitations such as the retrospective nature of the analysis, the small sample size and the short treatment period with only the lower dose of eptinezumab must be considered when interpreting the results.

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Section: Discussionmentioning

confidence: 99%

Effectiveness and tolerability of eptinezumab in treating patients with migraine resistant to conventional preventive medications and CGRP (receptor) antibodies: a multicentre retrospective real-world analysis from Germany

Scheffler,

Wenzel,

Bendig

et al. 2024

J Headache Pain

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“…Furthermore, we included and analyzed diverse reasons for switching, which included a lack of efficacy, adverse events, and loss of response. 22 23 …”

Section: Discussionmentioning

confidence: 99%

Treatment Outcome After Switching From Galcanezumab to Fremanezumab in Patients With Migraine

Youn,

Kim,

Lee

et al. 2024

J Clin Neurol

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Background and Purpose Monoclonal antibodies (mAbs) targeting calcitonin-gene-related peptide (CGRP) or its receptor (anti-CGRP-R) have been widely administered to patients with migraine who show inadequate responses to preventive medications. Among patients in whom a particular anti-CGRP-R mAb is ineffective, switching between different anti-CGRP-R mAbs can be the next option. Few studies have investigated treatment outcomes for antibody switching, especially between mAbs with the same target of the CGRP ligand. We aimed to determine the treatment outcome after switching between two anti-CGRP mAbs (galcanezumab to fremanezumab). Methods We identified migraine patients in a prospective headache clinic registry who received galcanezumab for ≥3 months and were switched to fremanezumab for a further ≥3 months at a single university hospital. We defined a treatment response as a ≥50% reduction in the number of days with a moderate or severe headache at the third month of treatment relative to baseline. The treatment response after switching to fremanezumab was compared with the initial treatment response to galcanezumab. Results Among 21 patients identified in the registry, 7 (33.3%) were initial responders to galcanezumab. After switching to fremanezumab, 7 (33.3%) showed a treatment response. The treatment response rate was 28.6% in the initial responders and 71.4% in the nonresponders to galcanezumab ( p >0.999). Conclusions Switching between anti-CGRP mAbs (galcanezumab to fremanezumab) yielded a treatment outcome comparable to that reported previously when switching from an anti-CGRP-R mAb (erenumab) to an anti-CGRP mAb (galcanezumab or fremanezumab). The treatment response to fremanezumab seems to be independent of the prior treatment response to galcanezumab. Our findings suggest that switching to another anti-CGRP mAb can be considered when a particular anti-CGRP mAb is ineffective or intolerable.

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“…In real-world observational studies, the ≥ 50% response rates to anti-CGRP(-R) mAbs range from 50% to 70% depending on baseline patient characteristics and duration of therapy, leaving 30%–50% of patients not benefiting significantly from treatment. Accumulating recent reports of non-responders to anti-CGRP(-R) mAbs and switchers [ 6 , 8 , 9 , 18 , 19 ], highlight the fact that, while anti-CGRP(-R) mAbs are highly effective and well-tolerated medications, they are not the panacea patients sometimes hope for, and have relevant limitations. This could be due to alternative neuropeptides and signaling pathways involved in migraine pathogenesis playing a more crucial role in the non-responders [ 20 , 21 ].…”

Section: Discussionmentioning

confidence: 99%

“…A treatment attempt with a second anti-CGRP(-R) mAb can eventually result in a clinically significant improvement in up to 45% of patients [ 6 – 8 ]. If no response was seen after the first switch, a second switch may still lead to a positive treatment outcome [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

Therapeutic patterns and migraine disease burden in switchers of CGRP-targeted monoclonal antibodies – insights from the German NeuroTransData registry

Hong,

Israel-Willner,

Peikert

et al. 2024

J Headache Pain

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Background Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have shown good efficacy in migraine prophylaxis. However, a subset of patients does not respond to the first mAb treatment and switches among the available mAbs. The goal of this study is to characterize the switching pattern of migraine patients treated with anti-CGRP(-receptor, -R) mAbs, and to describe the headache burden of those who did not switch, switched once, and switched twice. Methods This study used real world data from the NeuroTransData Cohort, a registry of migraine patients treated at outpatient neurology clinics across Germany. Patients who had received at least one anti-CGRP(-R) mAb were included. Headache diaries were collected at baseline and during treatment, along with quality of life measures every three months. Results were summarized for the subgroups of patients who did not switch and those with one and two switches. Results Of the 655 eligible patients, 479 did not switch, 135 switched once, 35 twice, and 6 three or more times. The ≥ 50% response rates for monthly migraine days were 64.7%, 50.7%, and 25.0% for the no switch, one switch, and two switches groups in their last treatment cycles, respectively. Quality of life measures improved for the no switch and one switch groups, but not for the two switches group. Conclusion Patients who switched among anti-CGRP(-R) mAbs during the course of their treatment still benefited overall but to a lesser extent than those who did not switch. Treatment response in patients who switched twice was markedly lower compared to the no switch and one switch subgroup.

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Monoclonal antibodies against CGRP (R): non-responders and switchers: real world data from an austrian case series

Cited by 10 publications

References 33 publications

Effectiveness and tolerability of eptinezumab in treating patients with migraine resistant to conventional preventive medications and CGRP (receptor) antibodies: a multicentre retrospective real-world analysis from Germany

Effectiveness and tolerability of eptinezumab in treating patients with migraine resistant to conventional preventive medications and CGRP (receptor) antibodies: a multicentre retrospective real-world analysis from Germany

Treatment Outcome After Switching From Galcanezumab to Fremanezumab in Patients With Migraine

Therapeutic patterns and migraine disease burden in switchers of CGRP-targeted monoclonal antibodies – insights from the German NeuroTransData registry

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