P171 Bimekizumab在活动性银屑病关节炎患者中保持疗效反应：两项3期研究长达2年的结果

IF 4.7 2区医学 Q1 RHEUMATOLOGY

Rheumatology Pub Date : 2025-04-28 DOI:10.1093/rheumatology/keaf142.208

Jessica A Walsh, Joseph F Merola, Christopher T Ritchlin, Yoshiya Tanaka, Ennio G Favalli, Dennis McGonagle, Diamant Thaçi, Barbara Ink, Rajan Bajracharya, Jason Coarse, William Tillett

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BE OPTIMAL Wk52 and BE COMPLETE Wk16 completers could enter BE VITAL (open-label extension; NCT04009499). Efficacy data reported for BKZ-randomised patients; safety data reported for all BKZ-treated patients. Maintenance of response reported as the proportion of Wk16 responders who were responders at Wk104/100 (BE OPTIMAL/BE COMPLETE). Efficacy outcomes include ACR20/50/70, Psoriasis Area and Severity Index (PASI)75/90/100, Minimal/Very Low Disease Activity (MDA/VLDA) and Disease Activity Index for PsA (DAPSA) remission or low disease activity responses (REM ≤4; REM+LDA ≤14); reported here to Wk104 (BE OPTIMAL) and Wk100 (BE COMPLETE). Data are reported as observed case or using non-responder or worst category imputation. Exposure-adjusted incidence rates per 100 patient-years (EAIR/100 PY) are reported to Wk104 for both bDMARD-naïve and TNFi-IR patients. Results Of BKZ-randomised patients, 359/431 (83.3%) bDMARD-naïve and 215/267 (80.5%) TNFi-IR completed Wk104/100. High proportions of patients achieving ACR50, PASI100 and MDA at Wk16 maintained responses at Wk104/100 (Table). At Wk16, 189 (43.9%) bDMARD-naïve and 115 (43.1%) TNFi-IR patients achieved ACR50; 150 (79.4%) bDMARD-naïve and 87 (75.7%) TNFi-IR patients maintained response at Wk104/100. At Wk16, 103/217 (47.5%) bDMARD-naïve and 103/176 (58.5%) TNFi-IR achieved PASI100; 73 (70.9%) bDMARD-naïve, 83 (80.6%) TNFi-IR patients maintained response at Wk104/100. At Wk16, 194 (45.0%) bDMARD-naïve and 117 (43.8%) TNFi-IR patients achieved MDA; 147 (75.8%) bDMARD-naïve, 87 (74.4%) TNFi-IR maintained response at Wk104/100. Results were similar for other joint/skin/composite efficacy outcomes at Wk104/100 (Table). To Wk104, the EAIR/100 PY for BKZ-treated patients with ≥1 treatment-emergent adverse event was 179.9 in bDMARD-naïve and 100.3 in TNFi-IR patients. Conclusion BKZ demonstrated robust maintenance of response at 2 years in bDMARD-naïve/TNFi-IR Wk16 responders among patients with PsA. Safety profile was consistent with previous reports. Disclosure J.A. Walsh: Consultancies; Consultant for/grant support from AbbVie, Amgen, Eli Lilly, Johnson & Johnson Innovative Medicine, Merck, Novartis, Pfizer and UCB. J.F. Merola: Consultancies; Consultant and/or investigator for AbbVie, Amgen, AstraZeneca, Biogen, BMS, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Johnson & Johnson Innovative Medicine, LEO Pharma, Consultant and/or investigator for MoonLake Immunotherapeutics, Novartis, Pfizer, Sanofi Regeneron, Sun Pharma and UCB. C.T. Ritchlin: Consultancies; Consultant for AbbVie, Amgen, BMS, Eli Lilly, Johnson & Johnson Innovative Medicine, MoonLake Immunotherapeutics, Novartis, Pfizer, Solarea and UCB. Other; Research for AbbVie. Y. Tanaka: Member of speakers’ bureau; Speaking fees and/or honoraria from AbbVie, Asahi-kasei, Astellas, AstraZeneca, Boehringer Ingelheim, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taisho, and UCB. Grants/research support; Grants from Boehringer Ingelheim, Chugai and Taisho. E.G. Favalli: Consultancies; Consultancy/speaker fees from AbbVie, BMS, Celltrion, Eli Lilly, Galapagos, Johnson & Johnson Innovative Medicine, MSD, Novartis, Pfizer and UCB. D. McGonagle: Consultancies; Consulting fees and honoraria from AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB. Member of speakers’ bureau; Speaker’s bureau for AbbVie, Celgene, Johnson & Johnson Innovative Medicine, Merck, Novartis, Pfizer and UCB. Grants/research support; Received grants/research support from AbbVie, Celgene, Johnson & Johnson Innovative Medicine, Merck, Novartis and Pfizer. D. Thaçi: Grants/research support; Received grants from AbbVie, LEO Pharma and Novartis. 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Efficacy outcomes include ACR20/50/70, Psoriasis Area and Severity Index (PASI)75/90/100, Minimal/Very Low Disease Activity (MDA/VLDA) and Disease Activity Index for PsA (DAPSA) remission or low disease activity responses (REM ≤4; REM+LDA ≤14); reported here to Wk104 (BE OPTIMAL) and Wk100 (BE COMPLETE). Data are reported as observed case or using non-responder or worst category imputation. Exposure-adjusted incidence rates per 100 patient-years (EAIR/100 PY) are reported to Wk104 for both bDMARD-naïve and TNFi-IR patients. Results Of BKZ-randomised patients, 359/431 (83.3%) bDMARD-naïve and 215/267 (80.5%) TNFi-IR completed Wk104/100. High proportions of patients achieving ACR50, PASI100 and MDA at Wk16 maintained responses at Wk104/100 (Table). At Wk16, 189 (43.9%) bDMARD-naïve and 115 (43.1%) TNFi-IR patients achieved ACR50; 150 (79.4%) bDMARD-naïve and 87 (75.7%) TNFi-IR patients maintained response at Wk104/100. At Wk16, 103/217 (47.5%) bDMARD-naïve and 103/176 (58.5%) TNFi-IR achieved PASI100; 73 (70.9%) bDMARD-naïve, 83 (80.6%) TNFi-IR patients maintained response at Wk104/100. At Wk16, 194 (45.0%) bDMARD-naïve and 117 (43.8%) TNFi-IR patients achieved MDA; 147 (75.8%) bDMARD-naïve, 87 (74.4%) TNFi-IR maintained response at Wk104/100. Results were similar for other joint/skin/composite efficacy outcomes at Wk104/100 (Table). To Wk104, the EAIR/100 PY for BKZ-treated patients with ≥1 treatment-emergent adverse event was 179.9 in bDMARD-naïve and 100.3 in TNFi-IR patients. Conclusion BKZ demonstrated robust maintenance of response at 2 years in bDMARD-naïve/TNFi-IR Wk16 responders among patients with PsA. Safety profile was consistent with previous reports. Disclosure J.A. Walsh: Consultancies; Consultant for/grant support from AbbVie, Amgen, Eli Lilly, Johnson & Johnson Innovative Medicine, Merck, Novartis, Pfizer and UCB. J.F. 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引用次数: 0

摘要

背景/目的：Bimekizumab （BKZ）在银屑病关节炎（PsA）患者的疗效结果中显示出具有临床意义的改善，持续到第16周（Wk），并持续到Wk52。我们报告了在bkz治疗的PsA患者中，维持关节/皮肤/复合疗效结果的Wk16应答者的比例至2年。方法两项3期研究评估BKZ每4周160mg在PsA患者中的作用：BE OPTIMAL(生物DMARD [bDMARD]-naïve；NCT03895203)和BE COMPLETE (TNF抑制剂反应不足/不耐受[TNFi-IR]；NCT03896581);两组均以Wk16为对照。BE OPTIMAL Wk52和BE COMPLETE Wk16完成者可进入BE VITAL(开放标签扩展；NCT04009499)。bkz随机分组患者的疗效数据报告；报告了所有bkz治疗患者的安全性数据。反应维持报告为Wk16反应者在Wk104/100（最佳/完全）反应者的比例。疗效指标包括ACR20/50/70，银屑病面积和严重程度指数（PASI）75/90/100, PsA （DAPSA）缓解或低疾病活动反应的最小/极低疾病活动（MDA/VLDA）和疾病活动指数(REM≤4；快速眼动+ LDA≤14);向Wk104（最佳）和Wk100（完成）报告。数据报告为观察到的病例或使用无应答者或最差类别归算。报告了bDMARD-naïve和TNFi-IR患者的每100患者年暴露调整发生率（EAIR/100 PY）至Wk104。在bkz随机分组的患者中，359/431 (83.3%)bDMARD-naïve和215/267（80.5%）的TNFi-IR完成了Wk104/100。在Wk16时达到ACR50、PASI100和MDA的患者比例较高，维持在Wk104/100时的应答（表）。在第16周，189 (43.9%)bDMARD-naïve和115 (43.1%)TNFi-IR患者达到ACR50；150例（79.4%）bDMARD-naïve和87例（75.7%）TNFi-IR患者维持Wk104/100的应答。在Wk16时，103/217 (47.5%)bDMARD-naïve和103/176（58.5%）的TNFi-IR达到PASI100；73例（70.9%）bDMARD-naïve， 83例（80.6%）TNFi-IR患者维持Wk104/100的应答。在第16周，194例（45.0%）bDMARD-naïve和117例（43.8%）TNFi-IR患者达到MDA；147 (75.8%) bDMARD-naïve, 87 (74.4%) TNFi-IR在Wk104/100维持应答。Wk104/100的其他关节/皮肤/复合疗效结果相似（表）。对于Wk104， bkz治疗的≥1个治疗不良事件患者的EAIR/100 PY在bDMARD-naïve组为179.9，在TNFi-IR组为100.3。结论：在PsA患者中bDMARD-naïve/TNFi-IR Wk16应答者中，BKZ在2年的疗效维持强劲。安全概况与之前的报告一致。J.A.沃尔什：咨询公司；艾伯维、安进、礼来、强生公司的顾问；强生创新医药、默克、诺华、辉瑞和UCB。J.F. Merola：咨询公司；AbbVie、Amgen、AstraZeneca、Biogen、BMS、Boehringer Ingelheim、Dermavant、Eli Lilly、Incyte、Johnson &amp的顾问和/或研究员；Johnson Innovative Medicine, LEO Pharma, MoonLake Immunotherapeutics, Novartis, Pfizer, Sanofi Regeneron， Sun Pharma和UCB的顾问和/或研究员。C.T. Ritchlin：咨询；艾伯维、安进、百时美施贵宝、礼来、强生顾问；Johnson Innovative Medicine, MoonLake Immunotherapeutics, Novartis, Pfizer， Solarea和UCB。其他;艾伯维的研究。田中：发言人主席团成员；来自艾伯维、旭化成、安斯泰来、阿斯利康、勃林格殷格翰、中盖、第一三共、卫赛、礼来、吉利德、GSK、辉瑞、大正和UCB的演讲费和/或酬金。授予/研究支持;勃林格殷格翰、中盖和大正的资助。法瓦利：咨询；艾伯维（AbbVie）、BMS、Celltrion、礼来（Eli Lilly）、加拉帕戈斯（Galapagos）、强生（Johnson &amp）；强生创新医药、默沙东、诺华、辉瑞和UCB。D.麦格教授：咨询；来自艾伯维、新基、杨森、默克、诺华、辉瑞和UCB的咨询费和酬金。发言人主席团成员；艾伯维（AbbVie）、新基（Celgene）、强生（Johnson &amp）的发言人办公室；强生创新医药、默克、诺华、辉瑞和UCB。授予/研究支持;获得艾伯维、新基、强生公司的资助/研究支持；强生创新医药，默克，诺华和辉瑞。D.科研经费/研究支助；获得艾伯维，利奥制药和诺华的资助。其他;AbbVie、Almirall、Amgen、BMS、Boehringer Ingelheim、Celltrion、Eli Lilly、Galderma、jansen - cilag、Kyowa Kirin、LEO Pharma、L 'Oreal、New Bridge、Novartis的研究员和/或顾问/顾问，Pfizer、Regeneron、Samsung、Sanofi、Target RWE、UCB和Vichy的研究员和/或顾问/顾问。B. Ink：公司任命；UCB员工；艾伯维、葛兰素史克和UCB的股东。R. Bajracharya：公司任命；UCB的员工和股东。J.粗俗：公司任命；UCB的员工和股东。W。 Tillett:其他;来自艾伯维、安进、BMS、新基、礼来、葛兰素史克、强生公司的研究经费、咨询费、演讲费和/或酬金；强生创新医药、默沙东、诺华、小野制药、辉瑞和UCB。

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P171 Bimekizumab maintained efficacy responses in patients with active psoriatic arthritis: up to 2-year results from two Phase 3 studies

Background/Aims Bimekizumab (BKZ) has demonstrated clinically meaningful improvements in efficacy outcomes to Week (Wk)16, that were sustained to Wk52, in psoriatic arthritis (PsA) patients. We report proportions of Wk16 responders maintaining response in joint/skin/composite efficacy outcomes to 2 years in BKZ-treated PsA patients. Methods Two Phase 3 studies assessed BKZ 160mg every 4 wks in PsA patients: BE OPTIMAL (biologic DMARD [bDMARD]-naïve; NCT03895203) and BE COMPLETE (TNF inhibitor inadequate response/intolerance [TNFi-IR]; NCT03896581); both placebo-controlled to Wk16. BE OPTIMAL Wk52 and BE COMPLETE Wk16 completers could enter BE VITAL (open-label extension; NCT04009499). Efficacy data reported for BKZ-randomised patients; safety data reported for all BKZ-treated patients. Maintenance of response reported as the proportion of Wk16 responders who were responders at Wk104/100 (BE OPTIMAL/BE COMPLETE). Efficacy outcomes include ACR20/50/70, Psoriasis Area and Severity Index (PASI)75/90/100, Minimal/Very Low Disease Activity (MDA/VLDA) and Disease Activity Index for PsA (DAPSA) remission or low disease activity responses (REM ≤4; REM+LDA ≤14); reported here to Wk104 (BE OPTIMAL) and Wk100 (BE COMPLETE). Data are reported as observed case or using non-responder or worst category imputation. Exposure-adjusted incidence rates per 100 patient-years (EAIR/100 PY) are reported to Wk104 for both bDMARD-naïve and TNFi-IR patients. Results Of BKZ-randomised patients, 359/431 (83.3%) bDMARD-naïve and 215/267 (80.5%) TNFi-IR completed Wk104/100. High proportions of patients achieving ACR50, PASI100 and MDA at Wk16 maintained responses at Wk104/100 (Table). At Wk16, 189 (43.9%) bDMARD-naïve and 115 (43.1%) TNFi-IR patients achieved ACR50; 150 (79.4%) bDMARD-naïve and 87 (75.7%) TNFi-IR patients maintained response at Wk104/100. At Wk16, 103/217 (47.5%) bDMARD-naïve and 103/176 (58.5%) TNFi-IR achieved PASI100; 73 (70.9%) bDMARD-naïve, 83 (80.6%) TNFi-IR patients maintained response at Wk104/100. At Wk16, 194 (45.0%) bDMARD-naïve and 117 (43.8%) TNFi-IR patients achieved MDA; 147 (75.8%) bDMARD-naïve, 87 (74.4%) TNFi-IR maintained response at Wk104/100. Results were similar for other joint/skin/composite efficacy outcomes at Wk104/100 (Table). To Wk104, the EAIR/100 PY for BKZ-treated patients with ≥1 treatment-emergent adverse event was 179.9 in bDMARD-naïve and 100.3 in TNFi-IR patients. Conclusion BKZ demonstrated robust maintenance of response at 2 years in bDMARD-naïve/TNFi-IR Wk16 responders among patients with PsA. Safety profile was consistent with previous reports. Disclosure J.A. Walsh: Consultancies; Consultant for/grant support from AbbVie, Amgen, Eli Lilly, Johnson & Johnson Innovative Medicine, Merck, Novartis, Pfizer and UCB. J.F. Merola: Consultancies; Consultant and/or investigator for AbbVie, Amgen, AstraZeneca, Biogen, BMS, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Johnson & Johnson Innovative Medicine, LEO Pharma, Consultant and/or investigator for MoonLake Immunotherapeutics, Novartis, Pfizer, Sanofi Regeneron, Sun Pharma and UCB. C.T. Ritchlin: Consultancies; Consultant for AbbVie, Amgen, BMS, Eli Lilly, Johnson & Johnson Innovative Medicine, MoonLake Immunotherapeutics, Novartis, Pfizer, Solarea and UCB. Other; Research for AbbVie. Y. Tanaka: Member of speakers’ bureau; Speaking fees and/or honoraria from AbbVie, Asahi-kasei, Astellas, AstraZeneca, Boehringer Ingelheim, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taisho, and UCB. Grants/research support; Grants from Boehringer Ingelheim, Chugai and Taisho. E.G. Favalli: Consultancies; Consultancy/speaker fees from AbbVie, BMS, Celltrion, Eli Lilly, Galapagos, Johnson & Johnson Innovative Medicine, MSD, Novartis, Pfizer and UCB. D. McGonagle: Consultancies; Consulting fees and honoraria from AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB. Member of speakers’ bureau; Speaker’s bureau for AbbVie, Celgene, Johnson & Johnson Innovative Medicine, Merck, Novartis, Pfizer and UCB. Grants/research support; Received grants/research support from AbbVie, Celgene, Johnson & Johnson Innovative Medicine, Merck, Novartis and Pfizer. D. Thaçi: Grants/research support; Received grants from AbbVie, LEO Pharma and Novartis. Other; Investigator and/or advisor/consultant for AbbVie, Almirall, Amgen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, L’Oreal, New Bridge, Novartis, Investigator and/or advisor/consultant for Pfizer, Regeneron, Samsung, Sanofi, Target RWE, UCB and Vichy. B. Ink: Corporate appointments; Employee of UCB; Shareholder of AbbVie, GSK and UCB. R. Bajracharya: Corporate appointments; Employee and shareholder of UCB. J. Coarse: Corporate appointments; Employee and shareholder of UCB. W. Tillett: Other; Research grants, consulting fees, speaking fees and/or honoraria from AbbVie, Amgen, BMS, Celgene, Eli Lilly, GSK, Johnson & Johnson Innovative Medicine, MSD, Novartis, Ono Pharma, Pfizer and UCB.

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来源期刊

Rheumatology 医学-风湿病学

CiteScore

9.40

自引率

7.30%

发文量

1091

审稿时长

2 months

期刊介绍： Rheumatology strives to support research and discovery by publishing the highest quality original scientific papers with a focus on basic, clinical and translational research. The journal’s subject areas cover a wide range of paediatric and adult rheumatological conditions from an international perspective. It is an official journal of the British Society for Rheumatology, published by Oxford University Press. Rheumatology publishes original articles, reviews, editorials, guidelines, concise reports, meta-analyses, original case reports, clinical vignettes, letters and matters arising from published material. The journal takes pride in serving the global rheumatology community, with a focus on high societal impact in the form of podcasts, videos and extended social media presence, and utilizing metrics such as Altmetric. Keep up to date by following the journal on Twitter @RheumJnl.