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P176 Ixekizumab significantly improves nail disease and adjacent joint tenderness and swelling in psoriatic arthritis
Rheumatology ( IF 5.5 ) Pub Date : 2024-04-24 , DOI: 10.1093/rheumatology/keae163.215
Dennis McGonagle 1 , Arthur Kavanaugh 2 , Iain McInnes 3 , Lars-Erik Kristensen 4 , Joseph Merola 5 , Bruce Strober 6 , Rebecca Bolce 7 , Jeffrey R Lisse 7 , Jennifer Pustizzi 7 , Christophe Sapin 7 , Christopher Ritchlin 8
Affiliation  

Background/Aims Nail psoriasis (PsO) is a strong predictor for the development of psoriatic arthritis (PsA) and has been reported in 63-83% of patients with PsA. Psoriatic nails are linked to arthritis in the adjacent distal interphalangeal joint (DIP) of fingers or interphalangeal joint of thumbs, and both can lead to severe functional impairment. In the SPIRIT-H2H study of adults with PsA, 354 of 566 participants had nail PsO and adjacent joint disease in at least one digit at baseline. At the group level, SPIRIT-H2H patients treated with ixekizumab (IXE) achieved significantly greater improvements in nail PsO compared to those treated with adalimumab (ADA). This analysis aimed to assess the treatment effects of IXE and ADA at the individual digit level among patients with PsA, nail PsO, and adjacent joint disease. Methods This post hoc analysis included 354 patients from SPIRIT-H2H (NCT03151551) treated with either IXE (N = 186) or ADA (N = 168) who had nail PsO (Nail Psoriasis Severity Index (NAPSI) total score >0) and adjacent joint disease (tenderness and/or swelling) in at least one digit at baseline. Treatment effects were assessed for each individual finger unit displaying nail PsO and adjacent joint disease; here, finger unit defines the nail and adjacent joint of an individual digit; adjacent joint refers to the DIP of fingers or the interphalangeal joint of thumbs. Nail PsO was measured using NAPSI in the fingers only. Joint involvement was measured by tender/swollen joint count scores (TJC68/SJC66). Patients were evaluated for both nail and joint involvement at baseline and Weeks 12, 16, 24, 32, 40, and 52. Proportions of finger units with resolution of nail PsO, and proportions of finger units with resolution of adjacent joint disease were analyzed using Chi-square tests. Non-responder imputation was used to handle missing data. Results There were 1309 (IXE=639, ADA=670) finger units affected by nail and adjacent joint disease at baseline. Resolution of psoriatic nail disease and resolution of adjacent tenderness and/or swelling of the finger unit was significantly higher with IXE vs ADA at all post-baseline assessments over 52 weeks. Joint tenderness was resolved in a significantly larger proportion of IXE-treated finger units vs ADA at all post-baseline assessments over 52 weeks. Joint swelling was resolved in a larger proportion of IXE-treated finger units vs ADA, and these differences reached statistical significance at all visits except Week 16 and Week 40. The tenderness and/or swelling of the finger unit resolved more rapidly than the adjacent nail disease. Conclusion IXE treatment showed a significant advantage over ADA in resolving nail PsO, joint tenderness, and joint swelling among the finger units with nail and adjacent joint disease of patients with PsA. Disclosure D. McGonagle: Consultancies; D. McGonagle has received consulting fees and/or honoraria and/or research grants from: AbbVie and Eli Lilly and Company. A. Kavanaugh: Consultancies; A. Kavanaugh has received consulting fees and/or honoraria from: AbbVie, Eli Lilly and Company, Janssen, Novartis, Pfizer, UCB Pharma. I. McInnes: Corporate appointments; Vice Principle & Head of College for University of Glasgow, non-executive board member of NHS Greater Glasgow & Clyde, non-executive director of Evelo, and trustee of Versus Arthritis. Consultancies; AbbVie, Amgen, Bristol Myers Squibb, Cabaletta Bio, Causeway Therapeutics, Eli Lilly and Company, Gilead Sciences, Janssen, Novartis, Pfizer, Sanofi Regeneron, and UCB Pharma. L. Kristensen: Grants/research support; AbbVie, Amgen, Biogen, Bristol Myers Squibb, Eli Lilly and Company, Gilead Sciences, Janssen, Merck Sharpe & Dohme, Novartis, Pfizer, and UCB Pharma. J. Merola: Consultancies; AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi Regeneron, Sun Pharma, and UCB Pharma. B. Strober: Corporate appointments; Editor-in-Chief for the Journal of Psoriasis and Psoriatic Arthritis and scientific co-director and investigator for CorEvitas Psoriasis Registry. Consultancies; AbbVie, Alamar Biosciences, Almirall, Alumis, Amgen, Arcutis, Arena Pharmaceuticals, Aristea Therapeutics, Asana Biosciences, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant. Shareholder/stock ownership; Connect Biopharma and Mindera. Honoraria; Eli Lilly and Company, Evelo Biosciences, Immunic Therapeutics, Incyte Corporation, Janssen, Kangpu Pharmaceuticals, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera, Nimbus Therapeutics, Novartis. Grants/research support; Pfizer, Protagonist Therapeutics, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma, Union Therapeutics, Ventyx Biosciences, and vTv Therapeutics. R. Bolce: Shareholder/stock ownership; R. Bolce is an employee and shareholder of Eli Lilly and Company. J.R. Lisse: Shareholder/stock ownership; J. Lisse is an employee and shareholder of Eli Lilly and Company. J. Pustizzi: Shareholder/stock ownership; J. Pustizzi is an employee and shareholder of: Eli Lilly and Company. C. Sapin: Shareholder/stock ownership; C. Sapin is an employee and shareholder of: Eli Lilly and Company. C. Ritchlin: Honoraria; AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Janssen, Novartis, Pfizer, and UCB Pharma.

中文翻译:

P176 Ixekizumab 显着改善银屑病关节炎的指甲疾病和邻近关节压痛和肿胀

背景/目的 指甲银屑病 (PsO) 是银屑病关节炎 (PsA) 发展的有力预测因素,据报道,63-83% 的 PsA 患者中有该病。银屑病指甲与相邻手指远端指间关节 (DIP) 或拇指指间关节的关节炎有关,两者都可能导致严重的功能障碍。在针对患有 PsA 的成人的 SPIRIT-H2H 研究中,566 名参与者中有 354 名在基线时至少有一位手指患有指甲 PsO 和邻近关节疾病。在组水平上,与使用阿达木单抗 (ADA) 治疗的患者相比,使用 ixekizumab (IXE) 治疗的 SPIRIT-H2H 患者的指甲 PsO 取得了显着更大的改善。该分析旨在评估 IXE 和 ADA 在 PsA、指甲 PsO 和邻近关节疾病患者的个体手指水平上的治疗效果。方法 这项事后分析包括来自 SPIRIT-H2H (NCT03151551) 的 354 名接受 IXE (N = 186) 或 ADA (N = 168) 治疗的患者,这些患者患有指甲 PsO(指甲银屑病严重指数 (NAPSI) 总分 > 0)并且基线时至少一位手指有邻近关节疾病(压痛和/或肿胀)。对显示指甲 PsO 和邻近关节疾病的每个手指单元的治疗效果进行评估;这里,手指单元定义了单个手指的指甲和相邻关节;邻关节是指手指的DIP或拇指的指间关节。仅使用 NAPSI 测量手指的指甲 PsO。通过压痛/肿胀关节计数评分(TJC68/SJC66)来测量关节受累情况。在基线和第 12、16、24、32、40 和 52 周时对患者的指甲和关节受累情况进行评估。使用指甲 PsO 解决方案的手指单位比例和邻近关节疾病解决方案的手指单位比例进行分析卡方检验。无应答者插补用于处理缺失数据。结果 基线时有 1309 个(IXE=639,ADA=670)个手指单位受到指甲和邻近关节疾病的影响。在 52 周的所有基线后评估中,与 ADA 相比,IXE 的银屑病指甲疾病的缓解率以及手指单位邻近压痛和/或肿胀的缓解率均显着更高。在 52 周的所有基线后评估中,与 ADA 相比,经 IXE 治疗的手指单位中关节压痛得到解决的比例明显更高。与 ADA 相比,经 IXE 治疗的手指单元中关节肿胀得到解决的比例更大,并且这些差异在除第 16 周和第 40 周外的所有访视中均达到统计学显着性。手指单元的压痛和/或肿胀比相邻指甲消退得更快疾病。结论 IXE治疗在解决PsA患者指甲及邻近关节病变的指甲PsO、关节压痛、关节肿胀等方面较ADA具有显着优势。披露 D. McGonagle:咨询; D. McGonagle 已从艾伯维 (AbbVie) 和礼来公司 (Eli Lilly and Company) 获得咨询费和/或酬金和/或研究资助。A.卡瓦诺:咨询; A. Kavanaugh 已收到以下机构的咨询费和/或酬金:艾伯维 (AbbVie)、礼来公司 (Eli Lilly and Company)、杨森 (Janssen)、诺华 (Novartis)、辉瑞 (Pfizer)、UCB Pharma。 I. McInnes:公司任命;格拉斯哥大学副校长兼学院院长、NHS Greater Glasgow & Clyde 非执行董事会成员、Evelo 非执行董事以及 Versus Arthritis 受托人。咨询;艾伯维、安进、百时美施贵宝、Cabaletta Bio、Causeway Therapeutics、礼来公司、吉利德科学、杨森、诺华、辉瑞、赛诺菲再生元和 UCB Pharma。 L. Kristensen:赠款/研究支持;艾伯维、安进、百健、百时美施贵宝、礼来公司、吉利德科学、杨森、默沙东、诺华、辉瑞和 UCB Pharma。 J. Merola:咨询;艾伯维、安进、百健、百时美施贵宝、Dermavant、礼来公司、杨森、LEO Pharma、诺华、辉瑞、赛诺菲再生元、Sun Pharma 和 UCB Pharma。 B. Strobe:公司任命; 《银屑病和银屑病关节炎杂志》主编,CorEvitas 银屑病登记处科学联合主任和研究员。咨询;艾伯维、Alamar Biosciences、Almirall、Alumis、安进、Arcutis、Arena Pharmaceuticals、Aristea Therapeutics、Asana Biosciences、勃林格殷格翰、百时美施贵宝、Connect Biopharma、Dermavant。股东/股权;连接 Biopharma 和 Mindera。酬金;礼来公司、Evelo Biosciences、Immunic Therapeutics、Incyte Corporation、杨森、Kangpu Pharmaceuticals、LEO Pharma、Maruho、Meiji Seika Pharma、Mindera、Nimbus Therapeutics、诺华。赠款/研究支持;辉瑞、Protagonist Therapeutics、Regeneron、赛诺菲健赞、Sun Pharma、UCB Pharma、Union Therapeutics、Ventyx Biosciences 和 vTv Therapeutics。 R. Bolce:股东/股权; R. Bolce 是礼来公司的员工和股东。 JR Lisse:股东/股权; J. Lisse 是礼来公司的员工和股东。 J. Pustizzi:股东/股权; J. Pustizzi 是礼来公司的员工和股东。 C. Sapin:股东/股权; C. Sapin 是礼来公司的员工和股东。 C. Ritchlin:酬金;艾伯维、百时美施贵宝、礼来公司、杨森、诺华、辉瑞和 UCB Pharma。百健(Biogen)、百时美施贵宝(Bristol Myers Squibb)、礼来公司(Eli Lilly and Company)、吉利德科学(Gilead Sciences)、杨森(Janssen)、默沙东(Merck Sharpe & Dohme)、诺华(Novartis)、辉瑞(Pfizer)和 UCB Pharma。 J. Merola:咨询;艾伯维、安进、百健、百时美施贵宝、Dermavant、礼来公司、杨森、LEO Pharma、诺华、辉瑞、赛诺菲再生元、Sun Pharma 和 UCB Pharma。 B. Strobe:公司任命; 《银屑病和银屑病关节炎杂志》主编,CorEvitas 银屑病登记处科学联合主任和研究员。咨询;艾伯维、Alamar Biosciences、Almirall、Alumis、安进、Arcutis、Arena Pharmaceuticals、Aristea Therapeutics、Asana Biosciences、勃林格殷格翰、百时美施贵宝、Connect Biopharma、Dermavant。股东/股权;连接 Biopharma 和 Mindera。酬金;礼来公司、Evelo Biosciences、Immunic Therapeutics、Incyte Corporation、杨森、Kangpu Pharmaceuticals、LEO Pharma、Maruho、Meiji Seika Pharma、Mindera、Nimbus Therapeutics、诺华。赠款/研究支持;辉瑞、Protagonist Therapeutics、Regeneron、赛诺菲健赞、Sun Pharma、UCB Pharma、Union Therapeutics、Ventyx Biosciences 和 vTv Therapeutics。 R. Bolce:股东/股权; R. Bolce 是礼来公司的员工和股东。 JR Lisse:股东/股权; J. Lisse 是礼来公司的员工和股东。 J. Pustizzi:股东/股权; J. Pustizzi 是礼来公司的员工和股东。 C. Sapin:股东/股权; C. Sapin 是礼来公司的员工和股东。 C. Ritchlin:酬金;艾伯维、百时美施贵宝、礼来公司、杨森、诺华、辉瑞和 UCB Pharma。百健(Biogen)、百时美施贵宝(Bristol Myers Squibb)、礼来公司(Eli Lilly and Company)、吉利德科学(Gilead Sciences)、杨森(Janssen)、默克夏普与多姆(Merck Sharpe & Dohme)、诺华(Novartis)、辉瑞(Pfizer)和 UCB Pharma。 J. Merola:咨询;艾伯维、安进、百健、百时美施贵宝、Dermavant、礼来公司、杨森、LEO Pharma、诺华、辉瑞、赛诺菲再生元、Sun Pharma 和 UCB Pharma。 B. Strobe:公司任命; 《银屑病和银屑病关节炎杂志》主编,CorEvitas 银屑病登记处科学联合主任和研究员。咨询;艾伯维、Alamar Biosciences、Almirall、Alumis、安进、Arcutis、Arena Pharmaceuticals、Aristea Therapeutics、Asana Biosciences、勃林格殷格翰、百时美施贵宝、Connect Biopharma、Dermavant。股东/股权;连接 Biopharma 和 Mindera。酬金;礼来公司、Evelo Biosciences、Immunic Therapeutics、Incyte Corporation、杨森、Kangpu Pharmaceuticals、LEO Pharma、Maruho、Meiji Seika Pharma、Mindera、Nimbus Therapeutics、诺华。赠款/研究支持;辉瑞、Protagonist Therapeutics、Regeneron、赛诺菲健赞、Sun Pharma、UCB Pharma、Union Therapeutics、Ventyx Biosciences 和 vTv Therapeutics。 R. Bolce:股东/股权; R. Bolce 是礼来公司的员工和股东。 JR Lisse:股东/股权; J. Lisse 是礼来公司的员工和股东。 J. Pustizzi:股东/股权; J. Pustizzi 是礼来公司的员工和股东。 C. Sapin:股东/股权; C. Sapin 是礼来公司的员工和股东。 C. Ritchlin:酬金;艾伯维、百时美施贵宝、礼来公司、杨森、诺华、辉瑞和 UCB Pharma。股东/股权; J. Lisse 是礼来公司的员工和股东。 J. Pustizzi:股东/股权; J. Pustizzi 是礼来公司的员工和股东。 C. Sapin:股东/股权; C. Sapin 是礼来公司的员工和股东。 C. Ritchlin:酬金;艾伯维、百时美施贵宝、礼来公司、杨森、诺华、辉瑞和 UCB Pharma。股东/股权; J. Lisse 是礼来公司的员工和股东。 J. Pustizzi:股东/股权; J. Pustizzi 是礼来公司的员工和股东。 C. Sapin:股东/股权; C. Sapin 是礼来公司的员工和股东。 C. Ritchlin:酬金;艾伯维、百时美施贵宝、礼来公司、杨森、诺华、辉瑞和 UCB Pharma。
更新日期:2024-04-24
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