Sustained benefits of onabotulinumtoxinA treatment in chronic migraine: An analysis of the pooled Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) randomized controlled trials Article Swipe
Stephen D. Silberstein
,
Hans‐Christoph Diener
,
David W. Dodick
,
Katherine Sommer
,
Richard B. Lipton
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1111/head.14743
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1111/head.14743
Objective To characterize the long‐term (56‐week) benefits of continuous onabotulinumtoxinA treatment response in individuals with chronic migraine (CM) who achieved reduction to <15 headache days/month with treatment. Background There are limited data exploring reductions in monthly headache days to levels consistent with episodic migraine among those experiencing CM. Understanding the impact of sustained preventive treatment response in CM can provide important information about the impact of successful therapy. Methods The two Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy trials of onabotulinumtoxinA in adults included a 24‐week, randomized, double‐blind, placebo‐controlled phase and a 32‐week open‐label phase. Data were pooled to determine proportions of individuals with <15 headache days/month while on treatment during several time periods in the double‐blind phase (Weeks 21–24; any 12 consecutive weeks; Weeks 13–24) and the entire study (Weeks 53–56; any 12 consecutive weeks; any 4‐week period). We assessed the long‐term impact on mean monthly headache days and changes from baseline on the six‐item Headache Impact Test (HIT‐6) and Migraine‐Specific Quality of Life questionnaire version 2.1 (MSQv2.1). Results We analyzed 1384 participants with chronic migraine (double‐blind: onabotulinumtoxinA, n = 688; placebo, n = 696; open‐label: n = 688 [onabotulinumtoxinA]). The discontinuation rates prior to the completion of the full 56‐week treatment period for onabotulinumtoxinA and placebo were 25.4% ( n = 175) and 29.3% ( n = 204), respectively. During Weeks 13–24 of the double‐blind phase, significantly more onabotulinumtoxinA‐treated (386/688 [56.1%]) than placebo‐treated (342/696 [49.1%]) individuals had <15 headache days/month ( p = 0.010), with fewer monthly headache days for onabotulinumtoxinA versus placebo responders. The proportions of participants achieving <15 monthly headache days with onabotulinumtoxinA were 60.9% (419/688) at Weeks 25–56, 81.1% (558/688) at Weeks 53–56, and 79.4% (546/688) during any consecutive 12‐week period. Mean changes from baseline on the HIT‐6 and MSQv2.1 questionnaire surpassed within‐group minimal important difference thresholds in all periods. At Week 24, onabotulinumtoxinA‐treated participants who achieved <15 monthly headache days during Weeks 21–24 had a greater mean HIT‐6 score reduction (−6.5 vs. −1.4) and greater mean MSQv2.1 Role‐Function Restrictive score improvements (21.3 vs. 6.4) than those who did not achieve <15 monthly headache days during the same period. Conclusions Participants who achieved <15 monthly headache days with onabotulinumtoxinA treatment achieved meaningful benefits in headache‐related disability and migraine‐specific quality of life compared with those who remained at or above the 15–monthly headache days threshold. Sustained benefits observed over 56 weeks support long‐term onabotulinumtoxinA use for the prevention of CM.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1111/head.14743
- https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/head.14743
- OA Status
- hybrid
- Cited By
- 5
- References
- 42
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4399922669
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4399922669Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1111/head.14743Digital Object Identifier
- Title
-
Sustained benefits of onabotulinumtoxinA treatment in chronic migraine: An analysis of the pooled Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) randomized controlled trialsWork title
- Type
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articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
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2024Year of publication
- Publication date
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2024-06-22Full publication date if available
- Authors
-
Stephen D. Silberstein, Hans‐Christoph Diener, David W. Dodick, Katherine Sommer, Richard B. LiptonList of authors in order
- Landing page
-
https://doi.org/10.1111/head.14743Publisher landing page
- PDF URL
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/head.14743Direct link to full text PDF
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YesWhether a free full text is available
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hybridOpen access status per OpenAlex
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/head.14743Direct OA link when available
- Concepts
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Discontinuation, Medicine, Migraine, Chronic Migraine, Placebo, Randomized controlled trial, Quality of life (healthcare), Anesthesia, Physical therapy, Internal medicine, Pathology, Alternative medicine, NursingTop concepts (fields/topics) attached by OpenAlex
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5Total citation count in OpenAlex
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2025: 4, 2024: 1Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.(56‐week) | 6 |
| abstract_inverted_index.Conclusions | 355 |
| abstract_inverted_index.Prophylaxis | 77 |
| abstract_inverted_index.Restrictive | 335 |
| abstract_inverted_index.consecutive | 123, 135, 284 |
| abstract_inverted_index.individuals | 14, 103, 238 |
| abstract_inverted_index.information | 62 |
| abstract_inverted_index.long‐term | 5, 143, 397 |
| abstract_inverted_index.proportions | 101, 258 |
| abstract_inverted_index.randomized, | 87 |
| abstract_inverted_index.responders. | 256 |
| abstract_inverted_index.15–monthly | 386 |
| abstract_inverted_index.Participants | 356 |
| abstract_inverted_index.characterize | 3 |
| abstract_inverted_index.experiencing | 47 |
| abstract_inverted_index.improvements | 337 |
| abstract_inverted_index.open‐label | 94 |
| abstract_inverted_index.participants | 174, 260, 310 |
| abstract_inverted_index.Understanding | 49 |
| abstract_inverted_index.open‐label: | 187 |
| abstract_inverted_index.questionnaire | 166, 296 |
| abstract_inverted_index.respectively. | 221 |
| abstract_inverted_index.significantly | 229 |
| abstract_inverted_index.double‐blind | 117, 227 |
| abstract_inverted_index.within‐group | 298 |
| abstract_inverted_index.Role‐Function | 334 |
| abstract_inverted_index.discontinuation | 193 |
| abstract_inverted_index.double‐blind, | 88 |
| abstract_inverted_index.(double‐blind: | 178 |
| abstract_inverted_index.placebo‐treated | 235 |
| abstract_inverted_index.headache‐related | 370 |
| abstract_inverted_index.onabotulinumtoxinA | 10, 81, 206, 253, 267, 364, 398 |
| abstract_inverted_index.Migraine‐Specific | 162 |
| abstract_inverted_index.migraine‐specific | 373 |
| abstract_inverted_index.onabotulinumtoxinA, | 179 |
| abstract_inverted_index.placebo‐controlled | 89 |
| abstract_inverted_index.[onabotulinumtoxinA]). | 191 |
| abstract_inverted_index.onabotulinumtoxinA‐treated | 231, 309 |
| cited_by_percentile_year.max | 98 |
| cited_by_percentile_year.min | 90 |
| corresponding_author_ids | https://openalex.org/A5083322806 |
| countries_distinct_count | 2 |
| institutions_distinct_count | 5 |
| corresponding_institution_ids | https://openalex.org/I2948539688, https://openalex.org/I4210139498 |
| citation_normalized_percentile.value | 0.9019122 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |