Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine : Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study
© 2024. The Author(s)..
INTRODUCTION: This analysis of two Japanese clinical trials evaluated efficacy and safety after galcanezumab (GMB) discontinuation in patients with episodic migraine (EM) and chronic migraine (CM).
METHODS: Data were from a 6-month, randomized, double-blind, placebo [PBO]-controlled primary trial (patients with EM) and a 12-month open-label extension trial (patients with EM/CM). Patients received 6 months' (primary) or 12/18 months' (extension) treatment with GMB 120 mg (GMB120) plus 240-mg loading dose or 240 mg (GMB240) with 4 months' post-treatment follow-up. Efficacy was assessed as number of monthly migraine headache days during post-treatment. Safety was assessed via post-treatment-emergent adverse events (PTEAEs).
RESULTS: The analysis population included 186 patients from the primary trial (PBO N = 93; GMB120 N = 45; GMB240 N = 48), 220 patients with EM from the extension trial (PBO/GMB120 N = 57; PBO/GMB240 N = 55; GMB120/GMB120 N = 55; GMB240/GMB240 N = 53), and 55 patients with CM (GMB120 N = 28; GMB240 N = 27). In patients with EM receiving 6 months' GMB120, mean standard deviation (SD) monthly migraine headache days increased from 5.69 (4.64) at treatment end to 6.24 (4.37) at end of follow-up but did not return to pre-treatment levels (8.80 [2.96]). In the extension trial, mean monthly migraine headache days in patients with EM receiving GMB120 were 4.13 (3.85) after 12 months and 4.45 (3.78) at end of follow-up, and 3.59 (3.48) after 18 months and 3.91 (3.57) at end of follow-up. Monthly migraine headache days in patients with CM (12 months' GMB120) were 10.71 (4.61) at treatment end and 11.17 (5.64) at end of follow-up (pre-treatment 20.15 [4.65]). Similar results were seen for patients receiving GMB240. The most observed PTEAE after GMB discontinuation was nasopharyngitis.
CONCLUSION: Galcanezumab exhibited post-treatment efficacy for up to 4 months in Japanese patients with EM and with CM. No unexpected safety signals were observed.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02959177 and NCT02959190.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
|---|---|
| Enthalten in: |
Neurology and therapy - (2024) vom: 06. Apr. |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Takeshima, Takao [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Anti-CGRP mAb |
|---|
| Anmerkungen: |
Date Revised 06.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT02959177, NCT02959190 Citation Status Publisher |
|---|
| doi: |
10.1007/s40120-024-00602-z |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM370710339 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM370710339 | ||
| 003 | DE-627 | ||
| 005 | 20240407232600.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240407s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s40120-024-00602-z |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1368.xml |
| 035 | |a (DE-627)NLM370710339 | ||
| 035 | |a (NLM)38581615 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Takeshima, Takao |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine |b Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 06.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02959177, NCT02959190 | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a INTRODUCTION: This analysis of two Japanese clinical trials evaluated efficacy and safety after galcanezumab (GMB) discontinuation in patients with episodic migraine (EM) and chronic migraine (CM) | ||
| 520 | |a METHODS: Data were from a 6-month, randomized, double-blind, placebo [PBO]-controlled primary trial (patients with EM) and a 12-month open-label extension trial (patients with EM/CM). Patients received 6 months' (primary) or 12/18 months' (extension) treatment with GMB 120 mg (GMB120) plus 240-mg loading dose or 240 mg (GMB240) with 4 months' post-treatment follow-up. Efficacy was assessed as number of monthly migraine headache days during post-treatment. Safety was assessed via post-treatment-emergent adverse events (PTEAEs) | ||
| 520 | |a RESULTS: The analysis population included 186 patients from the primary trial (PBO N = 93; GMB120 N = 45; GMB240 N = 48), 220 patients with EM from the extension trial (PBO/GMB120 N = 57; PBO/GMB240 N = 55; GMB120/GMB120 N = 55; GMB240/GMB240 N = 53), and 55 patients with CM (GMB120 N = 28; GMB240 N = 27). In patients with EM receiving 6 months' GMB120, mean standard deviation (SD) monthly migraine headache days increased from 5.69 (4.64) at treatment end to 6.24 (4.37) at end of follow-up but did not return to pre-treatment levels (8.80 [2.96]). In the extension trial, mean monthly migraine headache days in patients with EM receiving GMB120 were 4.13 (3.85) after 12 months and 4.45 (3.78) at end of follow-up, and 3.59 (3.48) after 18 months and 3.91 (3.57) at end of follow-up. Monthly migraine headache days in patients with CM (12 months' GMB120) were 10.71 (4.61) at treatment end and 11.17 (5.64) at end of follow-up (pre-treatment 20.15 [4.65]). Similar results were seen for patients receiving GMB240. The most observed PTEAE after GMB discontinuation was nasopharyngitis | ||
| 520 | |a CONCLUSION: Galcanezumab exhibited post-treatment efficacy for up to 4 months in Japanese patients with EM and with CM. No unexpected safety signals were observed | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02959177 and NCT02959190 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Anti-CGRP mAb | |
| 650 | 4 | |a Clinical factors | |
| 650 | 4 | |a Drug discontinuation | |
| 650 | 4 | |a Galcanezumab | |
| 650 | 4 | |a Japan | |
| 650 | 4 | |a Migraine disorders | |
| 650 | 4 | |a Migraine headache days | |
| 650 | 4 | |a Open-label extension study | |
| 650 | 4 | |a Post-treatment | |
| 650 | 4 | |a Randomized controlled trial | |
| 700 | 1 | |a Doi, Hikaru |e verfasserin |4 aut | |
| 700 | 1 | |a Ooba, Satomi |e verfasserin |4 aut | |
| 700 | 1 | |a Tanji, Yuka |e verfasserin |4 aut | |
| 700 | 1 | |a Ozeki, Akichika |e verfasserin |4 aut | |
| 700 | 1 | |a Komori, Mika |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Neurology and therapy |d 2012 |g (2024) vom: 06. Apr. |w (DE-627)NLM249263637 |x 2193-8253 |7 nnns |
| 773 | 1 | 8 | |g year:2024 |g day:06 |g month:04 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s40120-024-00602-z |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |j 2024 |b 06 |c 04 | ||