The impact of anti-CGRP monoclonal antibodies in resistant migraine patients: a real-world evidence observational study

Torres‐Ferrús, Marta; Gallardo, Víctor José; Alpuente, Alicia; Caronna, Edoardo; Giné-Ciprés, Eulalia; Pozo‐Rosich, Patricia

doi:10.1007/s00415-021-10523-8

Cited by 56 publications

(83 citation statements)

References 30 publications

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“…Taken together, these findings further speak to fremanezumab's potential to mitigate the significant disability associated with migraine [13], which is the top cause of years lived with disability among those 15 to 49 years of age [18]. Previous real-world studies have demonstrated that CGRP pathway-targeted therapies are effective as preventive treatments for migraine in adults [19][20][21][22]. In a Spanish prospective observational study of 155 migraine patients with ≥ 8 headache days per month and ≥ 3 prior preventive medication failures, treatment with erenumab (n = 109) or galcanezumab (n = 46) for 3 months resulted in a ≥ 50% reduction in migraine days per month in 51.6% of patients (mean [SD] reduction in migraine days per month compared with baseline was −8.5 [7.7]) [20].…”

Section: Discussionmentioning

confidence: 83%

“…Previous real-world studies have demonstrated that CGRP pathway-targeted therapies are effective as preventive treatments for migraine in adults [19][20][21][22]. In a Spanish prospective observational study of 155 migraine patients with ≥ 8 headache days per month and ≥ 3 prior preventive medication failures, treatment with erenumab (n = 109) or galcanezumab (n = 46) for 3 months resulted in a ≥ 50% reduction in migraine days per month in 51.6% of patients (mean [SD] reduction in migraine days per month compared with baseline was −8.5 [7.7]) [20]. In a sample of 81 Italian patients with high-frequency EM and CM, treatment with galcanezumab for 3 months resulted in a significant decrease in monthly migraine days compared with baseline (EM, −8.5; CM, −11.5; both P < 0.0001) [21].…”

Section: Discussionmentioning

confidence: 99%

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Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States

et al. 2021

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Background Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for migraine prevention in adults. Real-world data on the effectiveness of fremanezumab are limited. This retrospective, observational cohort study assessed patient-reported migraine symptoms, health care resource utilization (HCRU), and direct medical costs before and after fremanezumab treatment initiation. Methods Data were extracted from September 2018 through June 2020 from the Midwest component of EMRClaims+®, an integrated health services database containing > 20 million medical records from national commercial insurance claims, Medicare claims, and regional electronic medical records. Patients included in the cohort analysis were aged ≥ 18 years and were administered fremanezumab, with enrollment or treatment history for ≥ 6 months prior (pre-index) to initiating fremanezumab (index date) and ≥ 1 month after the index date (post-index), and without pregnancy or pregnancy-related encounters during the study period. Patient-reported headache frequency, migraine pain intensity (MPI), composite migraine symptoms, and HCRU were assessed pre-index and ≥ 1 month after fremanezumab initiation. Wilcoxon signed-rank tests were used to compare means of migraine symptoms and outcomes and HCRU before and after fremanezumab initiation. Results Overall, 172 patients were eligible for analysis. Of patients who self-reported (n = 129), 83.7% reported improvement in headache frequency or symptoms after fremanezumab treatment. Specifically, headache frequency decreased by 63% after fremanezumab initiation: mean (standard deviation) headache frequency was 22.24 (9.29) days per month pre-index versus 8.24 (7.42) days per month post-index (P < 0.0001). Mean MPI also decreased by 18% after fremanezumab initiation: MPI was 5.47 (3.19) pre-index versus 4.51 (3.34) post-index (P = 0.014). Mean emergency room (ER) visits per month decreased from 0.72 to 0.54 (P = 0.003), and mean outpatient visits per month decreased from 1.04 to 0.81 (P < 0.001). Mean hospitalizations per month decreased, but the results did not reach statistical significance (P = 0.095). Hospitalization and ER costs decreased, while outpatient costs increased, from pre-index to post-index, but differences were not statistically significant (P ≥ 0.232). Conclusions Significant reductions in headache frequency, MPI, and HCRU were observed after fremanezumab initiation in patients with migraine in a US real-world setting.

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Section: Discussionmentioning

confidence: 83%

Section: Discussionmentioning

confidence: 99%

Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States

et al. 2021

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“…A number of "real-world" studies and registries of migraine treatment with erenumab in North American (18)(19)(20)(21)(22)(23)(24)(25), European (26)(27)(28)(29)(30)(31)(32)(33), or Australian patients (34) have been published recently and included mainly patients with CM (Supplementary Table 1). With one exception (21), all the studies from North America were retrospective (18-20, 22, 23, 26), while all studies but two (26,30) studies from other geographic areas had a prospective design.…”

Section: Discussionmentioning

confidence: 99%

Erenumab for Migraine Prevention in a 1-Year Compassionate Use Program: Efficacy, Tolerability, and Differences Between Clinical Phenotypes

et al. 2021

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During a 1-year compassionate use program, 156 patients with migraine self-administered a monthly dose of erenumab 140 mg with a subcutaneous autoinjector. Main inclusion criteria were: ≥ 4 migraine days/month and ≥two prior prophylactic treatment failures. The patients covered the migraine severity spectrum from episodic migraine (EM) (n = 80) to chronic migraine (CM) (n = 76). During the 3rd month of treatment, monthly headache days decreased by 45.7% in EM and 35.5% in CM. The 50% responder rate for reduction in monthly headache days was significantly higher in EM (55%) than in CM (43%) (p = 0.05). In both the migraine subgroups, the clinical improvement vs. baseline was already significant during the 1st month of treatment (p < 0.001). There were also significant reductions in mean headache severity, duration, and monthly days with acute drug intake. The 30% responder rate at 3 months was 60% in CM and 54.1% of patients reversed from CM to EM. The therapeutic effect was maintained at 12 months when 50% responder rates, considering discontinuation for lack of efficacy or adverse effects as 0% response, still were 51% in EM and 41% in CM. A total of 10 patients with EM (12.5%) and 23 patients with CM (30.3%) had discontinued treatment, considering the treatment as ineffective. At 3 months, 48% of patients reported non-serious adverse events among which the most frequent was constipation (20.5%); corresponding figures at 12 months were 30 and 15%. Discontinuation due to an adverse effect for the entire 12 month period was rare (3.8%). The lower efficacy in CM than in EM was mainly due to a very low 50% responder rate in patients with CM with continuous pain (13%) as compared to CM with pain-free periods (58%) (p < 0.001). Similarly, the 50% responder rate was lower in patients with ≥two prior prophylactic treatment failures (40.5%) compared to those with two failures (70%) (p < 0.05). There was no significant efficacy difference between low (4–7 migraine days/month, n = 22) and high frequency (8–14 days, n = 59) EM nor between patients with CM with (n = 50) or without (n = 26) acute medication overuse. Erenumab had no effect on the frequency of auras. Taken together, erenumab 140 mg monthly was highly effective for migraine prophylaxis over the whole severity spectrum of the disease, except in patients with continuous headaches. Its effect is significant after the first injection, quasi-maximal after the second injection, and does not wear off after 12 months. The most frequent adverse effect was constipation. These results are compared to those published for erenumab in the pivotal randomized placebo-controlled trials and to those reported in several recent real-world studies.

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“…To date, there are no well-proven treatments available to reduce accompanying aura. An aura prevalence of 35 % - 52 % [ 10 – 12 ] and 23 % - 35 % [ 15 , 17 , 30 , 31 ] was reported in clinical trials and in real-world studies investigating erenumab, respectively. In our survey, physicians reported that 35 % of their patients had reduced accompanying aura, which was more pronounced in EM than in CM patients (41.7 % and 28.8 %).…”

Section: Discussionmentioning

confidence: 99%

“…Erenumab, the first-in-class fully human monoclonal antibody targeting the CGRP receptor, showed efficacy and safety in large randomized clinical trials for preventive treatment of migraine patients with and without prior treatment failures [ 9 – 12 ]. Recently published real-world data have further confirmed the efficacy and tolerability profile of erenumab in patients suffering from migraine who failed prior prophylactic treatments [ 13 – 31 ]. However, these real-world publications were mainly single-centre investigations, comprised of small patient population or did not focus on the German population.…”

Section: Introductionmentioning

confidence: 96%

Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany

Straube¹,

Stude²,

Gaul

et al. 2021

J Headache Pain

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Background Erenumab, the first-in-class fully human monoclonal antibody targeting the calcitonin gene-related peptide receptor, was shown to be efficacious and safe for the prophylactic treatment of migraine in adults in randomized clinical trials. Large-scale, real-world evidence in multi-centre settings is still needed to confirm these results. Erenumab patient profiles outside clinical trials and physicians’ treatment patterns, as well as data from patients treated in Germany, a severely impacted population, are not published yet. Methods TELESCOPE was a multi-centre survey gathering real-world data from 45 German headache centres between July 2019 and December 2019. The project consisted of two parts. In the first part, treating physicians shared their experiences on current erenumab treatment with regard to patient profiles, treatment patterns and treatment responses. In the second part, a retrospective chart review was conducted of 542 migraine patients treated with erenumab for at least three months. Treatment responses focused on various aspects of patients’ quality of life. Results The analysis of 542 patients’ charts revealed that three-month treatment with erenumab significantly reduced monthly headaches, migraine and acute medication days. Furthermore, headache intensity and frequency were reduced in over 75 % and accompanying aura in 35 % of patients. The clinical global impression scale revealed a general improvement in 91 % of patients. According to the treating physicians’ professional judgement, 83 % of patients responded to erenumab and 80 % were satisfied with the treatment. Physicians evaluated restricted quality of life, the number of monthly migraine days and previous, prophylactic treatments as the main components of the current patient profile for monoclonal antibody recipients. Based on the assessment of physicians, erenumab reduced migraine symptoms in 65 % and increased quality of life in more than 75 % of their patients. Conclusions TELESCOPE confirms positive treatment responses with erenumab shown in clinical trials in a real-world multi-centre setting. The results show consistently positive experiences of physicians utilizing erenumab in clinical practice and underline that therapy with this monoclonal antibody is effective in migraine patients, particular in those, who have failed several prophylactic therapies.

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The impact of anti-CGRP monoclonal antibodies in resistant migraine patients: a real-world evidence observational study

Cited by 56 publications

References 30 publications

Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States

Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States

Erenumab for Migraine Prevention in a 1-Year Compassionate Use Program: Efficacy, Tolerability, and Differences Between Clinical Phenotypes

Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany

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