John R Ingram, Hideki Fujita, Alice B Gottlieb, Hadar Lev-Tov, Errol Prens, Christopher J Sayed, Vivian Y Shi, Jacek C Szepietowski, Kenzo Takahashi, John W Frew, Jérémy Lambert, Leah Davis, Tae Oh, Robert Rolleri, Marie-Hélène Saintmard, Lauren A V Orenstein
{"title":"Bimekizumab治疗化脓性汗腺炎患者的疼痛结局：来自BE HEARD i和ii期随机临床试验的48周结果汇总","authors":"John R Ingram, Hideki Fujita, Alice B Gottlieb, Hadar Lev-Tov, Errol Prens, Christopher J Sayed, Vivian Y Shi, Jacek C Szepietowski, Kenzo Takahashi, John W Frew, Jérémy Lambert, Leah Davis, Tae Oh, Robert Rolleri, Marie-Hélène Saintmard, Lauren A V Orenstein","doi":"10.1007/s40122-025-00779-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Pain is a debilitating symptom of hidradenitis suppurativa (HS). Bimekizumab, a humanized IgG1 monoclonal antibody, selectively inhibits IL-17A and IL-17F. The impact of bimekizumab on pain outcomes in moderate to severe HS was assessed using pooled 48-week data from BE HEARD I&II (observed case and multiple imputation).</p><p><strong>Methods: </strong>Patients were randomized 2:2:2:1 to receive one of bimekizumab 320 mg every 2 weeks (Q2W); bimekizumab Q2W to Week 16, then every 4 weeks (Q4W) to Week 48; bimekizumab Q4W; or placebo to Week 16, then bimekizumab Q2W to Week 48. HS Symptom Daily Diary (HSSDD; baseline-Week 16) and HS Symptom Questionnaire (HSSQ; baseline, Weeks 16-48) assessed patient-reported skin pain. Mean scores, change from baseline (CfB), responder rates, shifts across pain severity categories, and association of HS Clinical Response (HiSCR) with pain outcomes were assessed.</p><p><strong>Results: </strong>A total of 1014 patients with moderate to severe HS were enrolled. Mean (standard deviation) age was 36.6 (12.2) years and 56.8% were women. Bimekizumab demonstrated rapid reductions in mean HSSDD worst and average skin pain scores after 2 weeks. Greater reductions from baseline in HSSDD worst (mean CfB ± standard error, bimekizumab Q2W: - 1.9 ± 0.1; bimekizumab Q4W: - 1.5 ± 0.2) and average skin pain scores (bimekizumab Q2W: - 1.8 ± 0.1; bimekizumab Q4W: - 1.4 ± 0.2) were observed at Week 16 versus placebo (worst: - 0.7 ± 0.2; average: - 0.8 ± 0.2). Mean HSSQ skin pain showed similar improvements to Week 16; further reductions were seen to Week 48 in those continually receiving bimekizumab. Week 16 placebo switchers saw rapid improvements in HSSQ skin pain scores from Week 16 to Week 18, comparable to those continually receiving bimekizumab. Responses were maintained to Week 48 (bimekizumab Q2W/Q2W: - 2.9 ± 0.2; bimekizumab Q2W/Q4W: - 2.5 ± 0.2; bimekizumab Q4W/Q4W: - 2.8 ± 0.2; placebo/bimekizumab Q2W: - 2.5 ± 0.3). Many patients shifted from severe/very severe to lower severity HSSQ skin pain categories (mild/no pain). Improvements corresponded with higher HiSCR scores at Week 48.</p><p><strong>Conclusions: </strong>Treatment with bimekizumab leads to rapid, continuous, and clinically meaningful reductions in skin pain.</p><p><strong>Trial registration: </strong>NCT04242446 ( https://clinicaltrials.gov/study/NCT04242446 ); NCT04242498 ( https://clinicaltrials.gov/study/NCT04242498 ). An Infographic is available for this article. Infographic.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Bimekizumab Pain Outcomes in Patients with Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II Phase 3 Randomized Clinical Trials.\",\"authors\":\"John R Ingram, Hideki Fujita, Alice B Gottlieb, Hadar Lev-Tov, Errol Prens, Christopher J Sayed, Vivian Y Shi, Jacek C Szepietowski, Kenzo Takahashi, John W Frew, Jérémy Lambert, Leah Davis, Tae Oh, Robert Rolleri, Marie-Hélène Saintmard, Lauren A V Orenstein\",\"doi\":\"10.1007/s40122-025-00779-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Pain is a debilitating symptom of hidradenitis suppurativa (HS). Bimekizumab, a humanized IgG1 monoclonal antibody, selectively inhibits IL-17A and IL-17F. The impact of bimekizumab on pain outcomes in moderate to severe HS was assessed using pooled 48-week data from BE HEARD I&II (observed case and multiple imputation).</p><p><strong>Methods: </strong>Patients were randomized 2:2:2:1 to receive one of bimekizumab 320 mg every 2 weeks (Q2W); bimekizumab Q2W to Week 16, then every 4 weeks (Q4W) to Week 48; bimekizumab Q4W; or placebo to Week 16, then bimekizumab Q2W to Week 48. HS Symptom Daily Diary (HSSDD; baseline-Week 16) and HS Symptom Questionnaire (HSSQ; baseline, Weeks 16-48) assessed patient-reported skin pain. Mean scores, change from baseline (CfB), responder rates, shifts across pain severity categories, and association of HS Clinical Response (HiSCR) with pain outcomes were assessed.</p><p><strong>Results: </strong>A total of 1014 patients with moderate to severe HS were enrolled. Mean (standard deviation) age was 36.6 (12.2) years and 56.8% were women. Bimekizumab demonstrated rapid reductions in mean HSSDD worst and average skin pain scores after 2 weeks. Greater reductions from baseline in HSSDD worst (mean CfB ± standard error, bimekizumab Q2W: - 1.9 ± 0.1; bimekizumab Q4W: - 1.5 ± 0.2) and average skin pain scores (bimekizumab Q2W: - 1.8 ± 0.1; bimekizumab Q4W: - 1.4 ± 0.2) were observed at Week 16 versus placebo (worst: - 0.7 ± 0.2; average: - 0.8 ± 0.2). Mean HSSQ skin pain showed similar improvements to Week 16; further reductions were seen to Week 48 in those continually receiving bimekizumab. Week 16 placebo switchers saw rapid improvements in HSSQ skin pain scores from Week 16 to Week 18, comparable to those continually receiving bimekizumab. Responses were maintained to Week 48 (bimekizumab Q2W/Q2W: - 2.9 ± 0.2; bimekizumab Q2W/Q4W: - 2.5 ± 0.2; bimekizumab Q4W/Q4W: - 2.8 ± 0.2; placebo/bimekizumab Q2W: - 2.5 ± 0.3). Many patients shifted from severe/very severe to lower severity HSSQ skin pain categories (mild/no pain). Improvements corresponded with higher HiSCR scores at Week 48.</p><p><strong>Conclusions: </strong>Treatment with bimekizumab leads to rapid, continuous, and clinically meaningful reductions in skin pain.</p><p><strong>Trial registration: </strong>NCT04242446 ( https://clinicaltrials.gov/study/NCT04242446 ); NCT04242498 ( https://clinicaltrials.gov/study/NCT04242498 ). An Infographic is available for this article. Infographic.</p>\",\"PeriodicalId\":19908,\"journal\":{\"name\":\"Pain and Therapy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2025-10-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pain and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40122-025-00779-7\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40122-025-00779-7","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Bimekizumab Pain Outcomes in Patients with Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II Phase 3 Randomized Clinical Trials.
Introduction: Pain is a debilitating symptom of hidradenitis suppurativa (HS). Bimekizumab, a humanized IgG1 monoclonal antibody, selectively inhibits IL-17A and IL-17F. The impact of bimekizumab on pain outcomes in moderate to severe HS was assessed using pooled 48-week data from BE HEARD I&II (observed case and multiple imputation).
Methods: Patients were randomized 2:2:2:1 to receive one of bimekizumab 320 mg every 2 weeks (Q2W); bimekizumab Q2W to Week 16, then every 4 weeks (Q4W) to Week 48; bimekizumab Q4W; or placebo to Week 16, then bimekizumab Q2W to Week 48. HS Symptom Daily Diary (HSSDD; baseline-Week 16) and HS Symptom Questionnaire (HSSQ; baseline, Weeks 16-48) assessed patient-reported skin pain. Mean scores, change from baseline (CfB), responder rates, shifts across pain severity categories, and association of HS Clinical Response (HiSCR) with pain outcomes were assessed.
Results: A total of 1014 patients with moderate to severe HS were enrolled. Mean (standard deviation) age was 36.6 (12.2) years and 56.8% were women. Bimekizumab demonstrated rapid reductions in mean HSSDD worst and average skin pain scores after 2 weeks. Greater reductions from baseline in HSSDD worst (mean CfB ± standard error, bimekizumab Q2W: - 1.9 ± 0.1; bimekizumab Q4W: - 1.5 ± 0.2) and average skin pain scores (bimekizumab Q2W: - 1.8 ± 0.1; bimekizumab Q4W: - 1.4 ± 0.2) were observed at Week 16 versus placebo (worst: - 0.7 ± 0.2; average: - 0.8 ± 0.2). Mean HSSQ skin pain showed similar improvements to Week 16; further reductions were seen to Week 48 in those continually receiving bimekizumab. Week 16 placebo switchers saw rapid improvements in HSSQ skin pain scores from Week 16 to Week 18, comparable to those continually receiving bimekizumab. Responses were maintained to Week 48 (bimekizumab Q2W/Q2W: - 2.9 ± 0.2; bimekizumab Q2W/Q4W: - 2.5 ± 0.2; bimekizumab Q4W/Q4W: - 2.8 ± 0.2; placebo/bimekizumab Q2W: - 2.5 ± 0.3). Many patients shifted from severe/very severe to lower severity HSSQ skin pain categories (mild/no pain). Improvements corresponded with higher HiSCR scores at Week 48.
Conclusions: Treatment with bimekizumab leads to rapid, continuous, and clinically meaningful reductions in skin pain.
Trial registration: NCT04242446 ( https://clinicaltrials.gov/study/NCT04242446 ); NCT04242498 ( https://clinicaltrials.gov/study/NCT04242498 ). An Infographic is available for this article. Infographic.
期刊介绍：
Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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