In search of a gold standard patient-reported outcome measure to use in the evaluation and treatment-decision making in migraine prevention. A real-world evidence study

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

doi:10.1186/s10194-021-01366-9

Cited by 23 publications

(48 citation statements)

References 42 publications

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“…Pain is a subjective experience that is difficult to assess thoroughly. It is well known that there are patients who may be satisfied by preventive treatments just by experiencing a reduction in pain and associated symptoms intensity [ 19 ]. If a check-point step is required to reduce costs associated to CGRP-mAbs, this should be built so as to guarantee treatment to all patients who can benefit.…”

Section: Discussionmentioning

confidence: 99%

“…A major concern for using a single numerical parameter as a mandatory criterion for the initiation and continuation of a preventive treatment is the limited ability to capture the multifaced disability that characterizes the migraine spectrum. On the other side, the reduction in monthly migraine days (MMDs), which represented a primary outcome for clinical trials, may not adequately reflect patients’ preferences and perspectives [ 18 , 19 ].…”

Section: Introductionmentioning

confidence: 99%

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Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial

et al. 2022

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Background In Italy, monoclonal antibodies targeting the CGRP pathway are subsidized for the preventive treatment of high frequency and chronic migraine (CM) in patients with a MIgraine Disability ASsessment (MIDAS) score ≥ 11. Eligibility to treatment continuation requires a ≥ 50% MIDAS score reduction at three months (T3). In this study, we evaluate whether a ≥ 50% MIDAS score reduction at T3 is a reliable predictor of response to one-year erenumab treatment. Methods In this prospective, open-label, real-world study, 77 CM patients were treated with erenumab 70–140 mg s.c. every 28 days for one year (T13). We collected the following variables: monthly migraine days (MMDs), monthly headache days (MHDs), days of acute medication intake, MIDAS, HIT-6, anxiety, depression, quality of life and allodynia. Response to erenumab was evaluated as: i) average reduction in MMDs during the 1-year treatment period; and ii) percentage of patients with ≥ 50% reduction in MMDs during the last 4 weeks after the 13 th injection (Responders T13 ). Results Erenumab induced a sustained reduction in MMDs, MHDs and intake of acute medications across the 12-month treatment period, with 64.9% of patients qualifying as Responders T13 . At T3, 55.8% of patients reported a ≥ 50% reduction in MIDAS score (MIDAS Res ) and 55.4% of patients reported a ≥ 50% reduction in MMDs (MMD Res ). MIDAS Res and MMD Res patients showed a more pronounced reduction in MMDs during the 1-year treatment as compared to NON-MIDAS Res (MIDAS Res : T0: 23.5 ± 4.9 vs. T13: 7.7 ± 6.2; NON- MIDAS Res : T0: 21.6 ± 5.4 vs. T13: 11.3 ± 8.8, p = 0.045) and NON-MMD Res (MMD Res : T0: 23.0 ± 4.5 vs. T13: 6.6 ± 4.8; NON-MMD Res : T0: 22.3 ± 6.0 vs. T13: 12.7 ± 9.2, p < 0.001) groups. The percentage of Responders T13 did not differ between MIDAS Res (74.4%) and NON-MIDAS Res (52.9%) patients ( p = 0.058), while the percentage of Responders T13 was higher in the MMD Res group (83.3%) when compared to NON-MMD Res (42.9%) ( p = 0.001). MMD Res predicted the long-term outcome according to a multivariate analysis (Exp(B) = 7.128; p = 0.001), while MIDAS Res did not. Treatment discontinuation based on MIDAS Res would have early excluded 36.0% of Responders T13 . ...

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial

et al. 2022

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“…From our multivariable analyses, we observed a steady increase in placebo response up until the mid 2000s, when the association thereafter essentially plateaued. This non-linear relationship could be an artefact of the data or could truly re ect real changes in the studies known to have happened during this time [44,45]. Our systematic literature review shows that older studies tended to use outcomes such as "migraine attacks/episodes" which are infrequently reported in the past decade.…”

Section: Discussionmentioning

confidence: 89%

The Temporal Trend of Placebo Response in Migraine Prevention from 1990 to 2021: A Systematic Literature Review and Meta-Analysis with Regression

Tepper

Cirillo

Kim

et al. 2023

Preprint

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Background Migraine affects 1.1 billion people globally and is the second leading cause of disability worldwide. In clinical trials, treatment efficacy is evaluated by comparing the differential responses in the treatment and placebo arms. Although placebo response in preventive migraine trials has been studied, there is limited research examining temporal trends. This study evaluates the trend of placebo response over thirty years in migraine prevention trials and investigates the association of potential confounders, such as patient, treatment, and study characteristics on placebo response using meta-analysis with regression. Methods We conducted literature searches from January 1990 to August 2021 in bibliographical databases (PubMed, Cochrane Library, and EMBASE). Studies were selected according to PICOS criteria and included randomized, double-blind, placebo-controlled trials evaluating preventive migraine treatments in adult patients diagnosed with episodic or chronic migraine, with or without aura. The protocol was registered with PROSPERO (CRD42021271732). Migraine efficacy outcomes included were either continuous (e.g., monthly migraine days) or dichotomous (e.g., ≥50% responder rate (yes/no)). We assessed the correlation of the change in outcome from baseline in the placebo arm, with the year of publication. The relationship between placebo response and year of publication was also assessed after accounting to confounders. Results A total of 907 studies were identified, and 83 were found eligible. For the continuous outcomes, the change from baseline in mean placebo response showed an increase over the years (rho=0.32, p=0.006). The multivariable regression analysis also showed an overall increase in placebo response over the years. The correlation analysis of dichotomous responses showed no significant linear trend between publication year and mean placebo response (rho=0.08, p=0.596). Placebo response also varied by route of administration. Conclusion Placebo response increased over the past 30 years in migraine preventive trials. This phenomenon should be considered when designing clinical trials and conducting meta-analyses.

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“…Since this is a real world-study with retrospective data acquisition, we were not able to include other relevant outcomes such as quality of life or patients' global impression of change. Further prospective studies on switching between CGRP mAbs in non-responders should choose a multi-dimensional outcome evaluation and include those patient-reported outcome parameters in addition to the reduction of MHD to acquire a more comprehensive assessment of treatment efficacy in this population ( 38 ).…”

Section: Discussionmentioning

confidence: 99%

Effect of switching to erenumab in non-responders to a CGRP ligand antibody treatment in migraine: A real-world cohort study

et al. 2023

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BackgroundTherapeutic options for migraine prevention in non-responders to monoclonal antibodies (mAbs) targeting Calcitonin Gene-Related Peptide (CGRP) and its receptor are often limited. Real-world data have shown that non-responders to the CGRP-receptor mAb erenumab may benefit from switching to a CGRP ligand mAb. However, it remains unclear whether, vice versa, erenumab is effective in non-responders to CGRP ligand mAbs. In this study, we aim to assess the efficacy of erenumab in patients who have previously failed a CGRP ligand mAb.MethodsThis monocentric retrospective cohort study included patients with episodic or chronic migraine in whom a non-response (< 30% reduction of monthly headache days during month 3 of treatment compared to baseline) to the CGRP ligand mAbs galcanezumab or fremanezumab led to a switch to erenumab, and who had received at least 3 administrations of erenumab. Monthly headache days were retrieved from headache diaries to assess the ≥30% responder rates and the absolute reduction of monthly headache days at 3 and 6 months of treatment with erenumab in this cohort.ResultsFrom May 2019 to July 2022, we identified 20 patients who completed 3 months of treatment with erenumab after non-response to a CGRP ligand mAb. Fourteen patients continued treatment for ≥6 months. The ≥30% responder rate was 35% at 3 months, and 45% at 6 months of treatment with erenumab, respectively. Monthly headache days were reduced from 18.6 ± 5.9 during baseline by 4.1 ± 3.1 days during month 3, and by 7.0 ± 4.8 days during month 6 compared to the month before treatment with erenumab (p < 0.001, respectively). Responders and non-responders to erenumab did not differ with respect to demographic or headache characteristics.ConclusionSwitching to erenumab in non-responders to a CGRP ligand mAb might be beneficial in a subgroup of resistant patients, with increasing responder rates after 6 months of treatment. Larger prospective studies should aim to predict which subgroup of patients benefit from a switch.

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In search of a gold standard patient-reported outcome measure to use in the evaluation and treatment-decision making in migraine prevention. A real-world evidence study

Cited by 23 publications

References 42 publications

Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial

Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial

The Temporal Trend of Placebo Response in Migraine Prevention from 1990 to 2021: A Systematic Literature Review and Meta-Analysis with Regression

Effect of switching to erenumab in non-responders to a CGRP ligand antibody treatment in migraine: A real-world cohort study

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