Observational studyEuropean journal of neurology2026
Association of Serum hs-CRP and TNF-α With Therapeutic Response to Erenumab for Migraine Prevention: A Registry for Migraine (REFORM) Study.
Observational study in European journal of neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
backgroundExperimental studies show inflammatory cytokines can modulate calcitonin gene-related peptide (CGRP) signaling, suggesting systemic inflammatory markers might reflect biological processes relevant to anti-CGRP therapies. We aimed to determine whether serum high-sensitivity C-reactive protein (hs-CRP) and tumor necrosis factor-alpha (TNF-α) are associated with erenumab response in adults with migraine and assess longitudinal biomarker changes during and after treatment.
methodsIn this prospective, observational single-center study, adults with episodic or chronic migraine self-administered 140 mg erenumab subcutaneously every 4 weeks for 24 weeks. Serum was collected at baseline, Week 24 (end of treatment), and Week 48 (24 weeks post-treatment). Treatment response was defined as a ≥ 50% reduction in monthly migraine days from baseline to Weeks 13-24. Logistic and linear regression models evaluated associations between baseline biomarkers and response, while longitudinal changes were analyzed using linear mixed-effects models.
resultsOf 679 enrolled participants, serum was analyzed in 623. Among 541 with sufficient data to determine response, 281 (51.9%) were responders. Neither baseline hs-CRP (OR 1.04; 95% CI 0.96-1.12; p = 0.30) nor TNF-α (OR 0.75; 95% CI 0.49-1.16; p = 0.20) predicted treatment response. TNF-α increased from baseline to Week 24 (mean rise 3.0%; 95% CI 0.5%-5.4%; p = 0.030), but no responder-non-responder differences were found.
conclusionsPeripheral inflammatory biomarkers such as hs-CRP and TNF-α neither predict response nor change meaningfully during CGRP-receptor blockade. These results suggest broadly applied inflammatory markers do not capture treatment-relevant biology and highlight the need for mechanism-specific biomarkers to advance personalized migraine therapy.
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