Search

Background: Switching between antibody classes might be a treatment option in migraine patients who have not responded to one class of a CGRP-(receptor) monoclonal antibody (mAb), but there are no efficacy data so far. In this real-world analysis, we assessed the treatment response to a CGRP-mAb in patients that have previously failed the CGRP-receptor-mAb erenumab. Methods: We analyzed retrospective headache diary data of 78 patients with migraine who switched between CGRP-mAbs classes at four German headache centers either due to lack of efficacy or intolerable side effects. Among these, we identified 25 patients who did not respond to erenumab after three treatment cycles (defined as <30% reduction of monthly headache days) and had complete headache documentation at least one month before and during both treatments. We assessed the ≥30% responder rate at month three after switching from erenumab to a CGRP-mAb (galcanezumab or fremanezumab) (primary endpoint). Secondary endpoints included ≥50% responder rate, monthly headache days, and monthly days with acute medication use. In an exploratory subgroup analysis patients were stratified for daily and non-daily headache. Results: The switch from erenumab to a CGRP-mAb led to a ≥30% response in one-third (32%) of the patients after three treatment cycles. A ≥50% response was achieved in 12% of the patients. Monthly headache days were reduced in month three compared to baseline (20.8 ± 7.1 to 17.8 ± 9.1; p = 0.009). Stratified analysis revealed that no patient with daily headache (n = 9) responded to the treatment switch, while a 30% response was achieved by 50% of patients with non-daily headache (n = 16). Conclusion: Our findings demonstrate that a relevant proportion of erenumab non-responders might benefit from a treatment switch to a CGRP-mAb. Switching seems to be a promising treatment option especially in migraine patients with non-daily headache. [ABSTRACT FROM AUTHOR]

Das Wirtschaftsstrafrecht sei beispielsweise dadurch gekennzeichnet, dass die Verfahrensbeteiligten prozessual häufig über das Verfahrensergebnis, den Verfahrensstoff und die Verfahrensregeln einzelfallbezogen verhandelten und somit u. U. von den formal bindenden Normen der Strafprozessordnung in der Weise abwichen, dass die Normen nicht angewendet würden oder die Rechtsfolgen nicht einträten. Professor I Singelnstein i kam unter dem Stichwort der "Gesellschaftlichen Praxis der Kriminalisierung" letztlich zu dem Schluss, dass es im Bereich der Fahrlässigkeit stärker als bei Vorsatztaten an dem aus gesellschaftlicher Perspektive eine Strafe rechtfertigenden Umstand fehle, dass neben die Abweichung von einer Norm die Abweichung der jeweiligen Täter vom durchschnittlichen Lebensstil der Gesamtbevölkerung trete. Professor I Singelnstein i ergänzte, dass auch er davon ausgehe, dass die Fahrlässigkeitsstrafbarkeit in der Praxis vor allem die Funktion hat, die Verursachung schwerer Folgen für die Gesellschaft sichtbar zu sanktionieren. Das bedeute, dass, wenn die Verantwortung in Bereichen, in denen Großschäden drohen, nicht wirklich gerecht dem Individuum zuzurechnen sei, die Scheinwaffe auf die Institutionen und die Möglichkeiten gerichtet werden müsste, die dort etwas ausrichten können. Insbesondere sollten nach dem Konzept der Veranstalterin und der Veranstalter der Hannoveraner Tagung die Fragen erörtert werden, was die Kriminalisierung fahrlässigen Verhaltens antreibe, wohin diese führe, wie die Argumente derer zu beurteilen seien, die die Fahrlässigkeit entkriminalisieren wollten und ob die Ausweitung der Fahrlässigkeitsstrafbarkeit nicht die Freiheit, Risiken einzugehen, gefährde. [Extracted from the article]

Objective: To assess the efficacy of monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor in chronic cluster headache (CCH) treatment under real world conditions. Background: Calcitonin gene-related peptide has an important pathophysiological role in cluster headache. Although the randomised controlled trial with the calcitonin gene-related peptide antibody galcanezumab was negative, chronic cluster headache patients with insufficient response to other preventive treatments have been receiving individual off-label treatment attempts with calcitonin gene-related peptide-(receptor) antibodies. Methods: Data from 22 chronic cluster headache patients who received at least one dose of a calcitonin gene-related peptide(-receptor) antibody and recorded attack frequency in a headache diary were retrospectively collected at eight headache centres. Results: The number of previous preventive therapies was 6.5 ± 2.4 (mean ± standard deviation, range: 2–11). The average number of attacks per week was 23.3 ± 16.4 at baseline and significantly decreased by −9.2 ± 9.7 in the first month of treatment with a calcitonin gene-related peptide(-receptor) antibody (p < 0.001). Fifty-five percent of the patients were 50% responders and 36% were 75% responders with respect to attack frequency. Significant reduction of attack frequency started at week 1 (−6.8 ± 2.8 attacks, p < 0.01). Results were corroborated by significant decreases in weekly uses of acute headache medication (−9.8 ± 7.6, p < 0.001) and pain intensity during attacks (−1.2 ± 2.0, numerical rating scale (NRS) [0–10], p < 0.01) in the first month. In months 2 (n = 14) and 3 (n = 10), reduction of attack frequency from baseline was −8.0 ± 8.4 (p = 0.004) and −9.1 ± 10.0 (p = 0.024), respectively. Conclusion: Under real-world conditions, individual treatment with calcitonin gene-related peptide(-receptor) antibodies was effective in 55% of our chronic cluster headache patients. This finding supports individual off-label treatment attempts with calcitonin gene-related peptide-(receptor) antibodies in chronic cluster headache patients insufficiently responding to other therapies. [ABSTRACT FROM AUTHOR]