Umberto Pensato, Raffaele Ornello, Chiara Rosignoli, Valeria Caponnetto, Agnese Onofri, Mark Braschinsky, Olga Sved, Raquel Gil-Gouveia, Renato Oliveira, Christian Lampl, Jakob Paungarttner, Paolo Martelletti, William David Wells-Gatnik, Isabel Pavao Martins, Dimos D Mitsikostas, Loukia Apostolakopoulou, Aynur Ozge, Dilan Bayar Narin, Patricia Pozo-Rosich, Albert Munoz-Vendrell, Maria Pia Prudenzano, Martino Gentile, Kristina Ryliskiene, Jurgita Vainauskiene, Margarita Sanchez-Del-Rio, Fabrizio Vernieri, Gianmarco Iaccarino, Marta Waliszewska-Prosół, Sławomir Budrewicz, Marta Carnovali, Zaza Katsarava, Simona Sacco
{"title":"顽固性和难治性偏头痛患者偏头痛负担的纵向评估——来自前瞻性REFINE研究的数据。","authors":"Umberto Pensato, Raffaele Ornello, Chiara Rosignoli, Valeria Caponnetto, Agnese Onofri, Mark Braschinsky, Olga Sved, Raquel Gil-Gouveia, Renato Oliveira, Christian Lampl, Jakob Paungarttner, Paolo Martelletti, William David Wells-Gatnik, Isabel Pavao Martins, Dimos D Mitsikostas, Loukia Apostolakopoulou, Aynur Ozge, Dilan Bayar Narin, Patricia Pozo-Rosich, Albert Munoz-Vendrell, Maria Pia Prudenzano, Martino Gentile, Kristina Ryliskiene, Jurgita Vainauskiene, Margarita Sanchez-Del-Rio, Fabrizio Vernieri, Gianmarco Iaccarino, Marta Waliszewska-Prosół, Sławomir Budrewicz, Marta Carnovali, Zaza Katsarava, Simona Sacco","doi":"10.1186/s10194-025-02126-9","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Some individuals with migraine fail to respond adequately to preventive treatments, bearing most of migraine burden. The European Headache Federation (EHF) classifies these individuals into resistant migraine (ResM) or refractory migraine (RefM) according to treatment failures, debilitating headache days, and disease duration. We investigated the evolution of these categories over six months in patients treated at tertiary headache centers and whether they accurately reflect disability and burden.</p><p><strong>Methods: </strong>Participants from the multicenter, prospective REFINE study were classified into three categories of treatment responsiveness, namely RefM, ResM, and non-refractory non-resistant migraine (NRNRM). The primary objective was to determine the trajectories of category changes over six months. Secondary outcomes included changes in the 6-item Headache Impact Test (HIT-6), Headache-Attributed Lost Time (HALT), and Hospital Anxiety and Depression Scale (HADS-A and HADS-D) scores.</p><p><strong>Results: </strong>Overall, 489 participants were included with a median age of 45 years (IQR = 36-53); 389 participants (79.7%) were female; 256 (52.4%) had NRNRM, 178 (36.4%) ResM, and 55 (11.2%) RefM. At follow-up, 200/256 (78.1%) NRNRM remained stable, while 56/256 (21.9%) progressed to ResM. Among those with ResM, 98/178 (55.1%) remained stable, 72/178 (40.5%) improved to NRNRM, and 8/178 (4.5%) worsened to RefM. Among participants with RefM, 37/55 (67.3%) remained stable, while 18/55 (32.7%) improved to NRNRM. Participants with RefM and ResM presented significantly higher scores at baseline than those with NRNRM. Over time, HIT-6, HALT, and HADS-A scores improved substantially in the overall cohort (p < 0.001, p < 0.001, and p = 0.006, respectively). Improvements were observed in participants with ResM across all scores and HIT-6 and HALT for NRNRM, but no improvement was noted in participants with RefM.</p><p><strong>Conclusions: </strong>Over six months, ~ 40% of ResM and ~ 30% of RefM individuals improved to NRNRM, while ~ 20% of NRNRM developed treatment resistance after receiving care in tertiary headache centers. Participants with ResM had a better prognosis than those with RefM. While both ResM and RefM reflect high migraine disability burden, they might present relevant differences in their management and prognosis.</p>","PeriodicalId":16013,"journal":{"name":"Journal of Headache and Pain","volume":"26 1","pages":"184"},"PeriodicalIF":7.9000,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12355733/pdf/","citationCount":"0","resultStr":"{\"title\":\"Longitudinal assessment of migraine burden in resistant and refractory migraine - Data from the prospective REFINE study.\",\"authors\":\"Umberto Pensato, Raffaele Ornello, Chiara Rosignoli, Valeria Caponnetto, Agnese Onofri, Mark Braschinsky, Olga Sved, Raquel Gil-Gouveia, Renato Oliveira, Christian Lampl, Jakob Paungarttner, Paolo Martelletti, William David Wells-Gatnik, Isabel Pavao Martins, Dimos D Mitsikostas, Loukia Apostolakopoulou, Aynur Ozge, Dilan Bayar Narin, Patricia Pozo-Rosich, Albert Munoz-Vendrell, Maria Pia Prudenzano, Martino Gentile, Kristina Ryliskiene, Jurgita Vainauskiene, Margarita Sanchez-Del-Rio, Fabrizio Vernieri, Gianmarco Iaccarino, Marta Waliszewska-Prosół, Sławomir Budrewicz, Marta Carnovali, Zaza Katsarava, Simona Sacco\",\"doi\":\"10.1186/s10194-025-02126-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Some individuals with migraine fail to respond adequately to preventive treatments, bearing most of migraine burden. The European Headache Federation (EHF) classifies these individuals into resistant migraine (ResM) or refractory migraine (RefM) according to treatment failures, debilitating headache days, and disease duration. We investigated the evolution of these categories over six months in patients treated at tertiary headache centers and whether they accurately reflect disability and burden.</p><p><strong>Methods: </strong>Participants from the multicenter, prospective REFINE study were classified into three categories of treatment responsiveness, namely RefM, ResM, and non-refractory non-resistant migraine (NRNRM). The primary objective was to determine the trajectories of category changes over six months. Secondary outcomes included changes in the 6-item Headache Impact Test (HIT-6), Headache-Attributed Lost Time (HALT), and Hospital Anxiety and Depression Scale (HADS-A and HADS-D) scores.</p><p><strong>Results: </strong>Overall, 489 participants were included with a median age of 45 years (IQR = 36-53); 389 participants (79.7%) were female; 256 (52.4%) had NRNRM, 178 (36.4%) ResM, and 55 (11.2%) RefM. At follow-up, 200/256 (78.1%) NRNRM remained stable, while 56/256 (21.9%) progressed to ResM. Among those with ResM, 98/178 (55.1%) remained stable, 72/178 (40.5%) improved to NRNRM, and 8/178 (4.5%) worsened to RefM. Among participants with RefM, 37/55 (67.3%) remained stable, while 18/55 (32.7%) improved to NRNRM. Participants with RefM and ResM presented significantly higher scores at baseline than those with NRNRM. Over time, HIT-6, HALT, and HADS-A scores improved substantially in the overall cohort (p < 0.001, p < 0.001, and p = 0.006, respectively). Improvements were observed in participants with ResM across all scores and HIT-6 and HALT for NRNRM, but no improvement was noted in participants with RefM.</p><p><strong>Conclusions: </strong>Over six months, ~ 40% of ResM and ~ 30% of RefM individuals improved to NRNRM, while ~ 20% of NRNRM developed treatment resistance after receiving care in tertiary headache centers. Participants with ResM had a better prognosis than those with RefM. 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Longitudinal assessment of migraine burden in resistant and refractory migraine - Data from the prospective REFINE study.
Background: Some individuals with migraine fail to respond adequately to preventive treatments, bearing most of migraine burden. The European Headache Federation (EHF) classifies these individuals into resistant migraine (ResM) or refractory migraine (RefM) according to treatment failures, debilitating headache days, and disease duration. We investigated the evolution of these categories over six months in patients treated at tertiary headache centers and whether they accurately reflect disability and burden.
Methods: Participants from the multicenter, prospective REFINE study were classified into three categories of treatment responsiveness, namely RefM, ResM, and non-refractory non-resistant migraine (NRNRM). The primary objective was to determine the trajectories of category changes over six months. Secondary outcomes included changes in the 6-item Headache Impact Test (HIT-6), Headache-Attributed Lost Time (HALT), and Hospital Anxiety and Depression Scale (HADS-A and HADS-D) scores.
Results: Overall, 489 participants were included with a median age of 45 years (IQR = 36-53); 389 participants (79.7%) were female; 256 (52.4%) had NRNRM, 178 (36.4%) ResM, and 55 (11.2%) RefM. At follow-up, 200/256 (78.1%) NRNRM remained stable, while 56/256 (21.9%) progressed to ResM. Among those with ResM, 98/178 (55.1%) remained stable, 72/178 (40.5%) improved to NRNRM, and 8/178 (4.5%) worsened to RefM. Among participants with RefM, 37/55 (67.3%) remained stable, while 18/55 (32.7%) improved to NRNRM. Participants with RefM and ResM presented significantly higher scores at baseline than those with NRNRM. Over time, HIT-6, HALT, and HADS-A scores improved substantially in the overall cohort (p < 0.001, p < 0.001, and p = 0.006, respectively). Improvements were observed in participants with ResM across all scores and HIT-6 and HALT for NRNRM, but no improvement was noted in participants with RefM.
Conclusions: Over six months, ~ 40% of ResM and ~ 30% of RefM individuals improved to NRNRM, while ~ 20% of NRNRM developed treatment resistance after receiving care in tertiary headache centers. Participants with ResM had a better prognosis than those with RefM. While both ResM and RefM reflect high migraine disability burden, they might present relevant differences in their management and prognosis.
期刊介绍：
The Journal of Headache and Pain, a peer-reviewed open-access journal published under the BMC brand, a part of Springer Nature, is dedicated to researchers engaged in all facets of headache and related pain syndromes. It encompasses epidemiology, public health, basic science, translational medicine, clinical trials, and real-world data.
With a multidisciplinary approach, The Journal of Headache and Pain addresses headache medicine and related pain syndromes across all medical disciplines. It particularly encourages submissions in clinical, translational, and basic science fields, focusing on pain management, genetics, neurology, and internal medicine. The journal publishes research articles, reviews, letters to the Editor, as well as consensus articles and guidelines, aimed at promoting best practices in managing patients with headaches and related pain.
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