Lina S Alahmadi, Ahmed M Alhazmi, Samaher I Alaauldeen, Rand M Melibari, Eman A Alsindi, Reem M Hafiz, Yara F Alqurashi, Raghad A Alrowithi, Hala M Albuti
{"title":"阿巴接受在沙特阿拉伯西部地区类风湿关节炎患者中的疗效和安全性：一项多中心研究","authors":"Lina S Alahmadi, Ahmed M Alhazmi, Samaher I Alaauldeen, Rand M Melibari, Eman A Alsindi, Reem M Hafiz, Yara F Alqurashi, Raghad A Alrowithi, Hala M Albuti","doi":"10.1186/s41927-025-00549-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Rheumatoid arthritis (RA) in adult patients, there is contradictory evidence regarding Abatacept's safety profile (ABA). This study aims to assess the safety and efficacy of ABA in adult patients in Saudi Arabia.</p><p><strong>Methods: </strong>This retrospective cohort study analyzed adult patients aged 18 and above with RA who received ABA at King Fahad Armed Forces Hospital, and King Fahad General Hospital, and Al-Noor Specialist Hospital in Saudi Arabia. Data was collected from electronic medical records, and analyzed using the statistical analyses (IBM's SPSS Software, version 29.0).</p><p><strong>Results: </strong>The study included 236 RA patients (88.6% female), with a mean age of 55.7 years. Comorbidities were present in 64.6%, and the average disease duration was 127.1 months. Joint erosion was the most common feature (49.6%), while 25% had extra-articular manifestations. Abnormal labs included elevated liver enzymes and leukocytosis. After 6 months of ABA, DAS-28 scores significantly decreased to a mean of 3.07 (SD = 1.31; p < 0.001). The mean treatment duration was 28.0 months, with a 31.8% discontinuation rate-mainly due to secondary failure (41.1%), primary failure (17.9%), and non-compliance (10.7%). Discontinuation was more frequent in females (p = 0.049). ADRs (Adverse drug reactions) included cytopenia in 8.6% (n = 18), mainly anemia. liver enzyme elevations, GI upset, HBV reactivation, and one malignancy, but none were statistically significant (all p > 0.05). tuberculosis (TB) reactivation occurred in 2 patients (0.8%), neither discontinued the drug (p = 0.565). Notably, 45.3% were biologic-naïve and showed better outcomes: greater DAS-28 reduction (2.1 vs. 1.5; p = 0.015) and lower discontinuation rates (24.3% vs. 38.8%; p = 0.028) than biologic-switch patients.</p><p><strong>Conclusion: </strong>The study confirms the safety and efficacy of ABA in treating RA in Saudi Arabian adults. It found significant improvements in disease activity, but with high discontinuation rates though aligning with previous studies. We recommend measures targeting identified possible causes and extensive research to explore the safety and efficacy of ABA.</p><p><strong>Clinical trial number: </strong>Not applicable.</p>","PeriodicalId":9150,"journal":{"name":"BMC Rheumatology","volume":"9 1","pages":"96"},"PeriodicalIF":2.5000,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12323098/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of abatacept in rheumatoid arthritis patients in Western region in Saudi Arabia: a multi-center study.\",\"authors\":\"Lina S Alahmadi, Ahmed M Alhazmi, Samaher I Alaauldeen, Rand M Melibari, Eman A Alsindi, Reem M Hafiz, Yara F Alqurashi, Raghad A Alrowithi, Hala M Albuti\",\"doi\":\"10.1186/s41927-025-00549-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Rheumatoid arthritis (RA) in adult patients, there is contradictory evidence regarding Abatacept's safety profile (ABA). 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The mean treatment duration was 28.0 months, with a 31.8% discontinuation rate-mainly due to secondary failure (41.1%), primary failure (17.9%), and non-compliance (10.7%). Discontinuation was more frequent in females (p = 0.049). ADRs (Adverse drug reactions) included cytopenia in 8.6% (n = 18), mainly anemia. liver enzyme elevations, GI upset, HBV reactivation, and one malignancy, but none were statistically significant (all p > 0.05). tuberculosis (TB) reactivation occurred in 2 patients (0.8%), neither discontinued the drug (p = 0.565). Notably, 45.3% were biologic-naïve and showed better outcomes: greater DAS-28 reduction (2.1 vs. 1.5; p = 0.015) and lower discontinuation rates (24.3% vs. 38.8%; p = 0.028) than biologic-switch patients.</p><p><strong>Conclusion: </strong>The study confirms the safety and efficacy of ABA in treating RA in Saudi Arabian adults. 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引用次数: 0
摘要
在成人类风湿关节炎（RA）患者中，关于abataccept的安全性（ABA）存在矛盾的证据。本研究旨在评估ABA在沙特阿拉伯成人患者中的安全性和有效性。方法：本回顾性队列研究分析了在沙特阿拉伯法赫德国王武装部队医院、法赫德国王总医院和Al-Noor专科医院接受ABA治疗的18岁及以上成年RA患者。数据从电子病历中收集，并使用统计分析（IBM的SPSS软件，版本29.0）进行分析。结果：研究纳入236例RA患者（88.6%为女性），平均年龄55.7岁。合并症发生率为64.6%，平均病程为127.1个月。关节糜烂是最常见的特征（49.6%），而25%有关节外表现。异常实验包括肝酶升高和白细胞增多。ABA治疗6个月后，DAS-28评分显著下降至平均3.07分(SD = 1.31；p 0.05)。2例患者（0.8%）发生结核病（TB）再激活，均未停药（p = 0.565）。值得注意的是，45.3%的患者biologic-naïve表现出更好的结果：更大的DAS-28降低(2.1 vs. 1.5；P = 0.015)和较低的停药率(24.3% vs. 38.8%；P = 0.028)。结论：本研究证实了ABA治疗沙特阿拉伯成人类风湿性关节炎的安全性和有效性。它发现疾病活动有显著改善，但停药率很高，尽管与之前的研究一致。我们建议针对可能的原因采取措施，并进行广泛的研究，以探索ABA的安全性和有效性。临床试验号：不适用。
Efficacy and safety of abatacept in rheumatoid arthritis patients in Western region in Saudi Arabia: a multi-center study.
Introduction: Rheumatoid arthritis (RA) in adult patients, there is contradictory evidence regarding Abatacept's safety profile (ABA). This study aims to assess the safety and efficacy of ABA in adult patients in Saudi Arabia.
Methods: This retrospective cohort study analyzed adult patients aged 18 and above with RA who received ABA at King Fahad Armed Forces Hospital, and King Fahad General Hospital, and Al-Noor Specialist Hospital in Saudi Arabia. Data was collected from electronic medical records, and analyzed using the statistical analyses (IBM's SPSS Software, version 29.0).
Results: The study included 236 RA patients (88.6% female), with a mean age of 55.7 years. Comorbidities were present in 64.6%, and the average disease duration was 127.1 months. Joint erosion was the most common feature (49.6%), while 25% had extra-articular manifestations. Abnormal labs included elevated liver enzymes and leukocytosis. After 6 months of ABA, DAS-28 scores significantly decreased to a mean of 3.07 (SD = 1.31; p < 0.001). The mean treatment duration was 28.0 months, with a 31.8% discontinuation rate-mainly due to secondary failure (41.1%), primary failure (17.9%), and non-compliance (10.7%). Discontinuation was more frequent in females (p = 0.049). ADRs (Adverse drug reactions) included cytopenia in 8.6% (n = 18), mainly anemia. liver enzyme elevations, GI upset, HBV reactivation, and one malignancy, but none were statistically significant (all p > 0.05). tuberculosis (TB) reactivation occurred in 2 patients (0.8%), neither discontinued the drug (p = 0.565). Notably, 45.3% were biologic-naïve and showed better outcomes: greater DAS-28 reduction (2.1 vs. 1.5; p = 0.015) and lower discontinuation rates (24.3% vs. 38.8%; p = 0.028) than biologic-switch patients.
Conclusion: The study confirms the safety and efficacy of ABA in treating RA in Saudi Arabian adults. It found significant improvements in disease activity, but with high discontinuation rates though aligning with previous studies. We recommend measures targeting identified possible causes and extensive research to explore the safety and efficacy of ABA.
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