{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T16:50:26Z","timestamp":1786467026041,"version":"build-2736575974"},"reference-count":21,"publisher":"S. Karger AG","license":[{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacology"],"abstract":"<jats:p>Introduction: Anifrolumab, a type I interferon receptor antagonist, has shown effectiveness in treating moderate-to-severe systemic lupus erythematosus (SLE). To fully understand its long-term efficacy, glucocorticoid (GC)-sparing potential, and cumulative safety profile in everyday clinical practice, it is essential to combine up to 4 years of long-term extension (LTE) trial data with emerging real-world evidence (RWE). Methods: A systematic literature search was performed across major electronic databases to identify phase 2\/3 randomized controlled trials (RCTs), LTE studies, and RWE cohorts assessing anifrolumab in SLE. Comparative odds ratios (ORs) for RCTs were calculated using the Mantel-Haenszel method, while pooled proportions for single-arm RWE cohorts were estimated using a random-effects model. Primary outcomes included BICLA response, Lupus Low Disease Activity State (LLDAS), GC reduction (to \u22647.5 mg\/day), and herpes zoster (HZ) incidence. Results: Ten studies were included, comprising phase 2\/3 RCTs, their LTEs (TULIP-LTE, MUSE-LTE), and four European RWE cohorts. In the RCTs (N = 1,093), anifrolumab significantly improved BICLA responses compared to placebo (pooled OR 1.85, 95% CI 1.42\u20132.41, p &lt; 0.001) and enhanced the likelihood of achieving a target GC dose of \u2264 7.5 mg\/day (OR 2.24, 95% CI 1.52\u20133.29, p &lt; 0.001). In the pooled RWE cohorts (N = 294), the estimated attainment rate for LLDAS at 6\u201312 months was notably high at 75.8% (95% CI 68.4\u201382.5%). Additionally, 72.5% of real-world patients achieved a &gt;50% reduction in GC dosage. Regarding safety, there was no significant increase in overall serious adverse events (OR 0.82, p = 0.25). Although anifrolumab was linked to a higher risk of HZ (OR 3.45, 95% CI 1.95\u20136.10, p &lt; 0.001), both LTE and RWE data indicated that these cases were mainly mild to moderate and manageable. Conclusion: Anifrolumab offers rapid, strong, and sustained disease control while providing significant GC-sparing effects in both tightly controlled clinical trials and diverse real-world populations. The long-term safety profile remains stable; however, preventative measures, such as HZ vaccination, should be implemented as part of standard care.<\/jats:p>","DOI":"10.1159\/000553444","type":"journal-article","created":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T16:04:38Z","timestamp":1783353878000},"page":"1-12","source":"Crossref","is-referenced-by-count":0,"title":["Long-Term Safety and Efficacy of Anifrolumab in Systemic Lupus Erythematosus: A Meta-Analysis of Randomized Controlled Trials, Extension Studies, and Real-World Cohorts"],"prefix":"10.1159","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4213-1909","authenticated-orcid":false,"given":"Young Ho","family":"Lee","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gwan Gyu","family":"Song","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2026,7,6]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2025.0053"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2025.0032"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/ker410"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1136\/ard-2023-224762"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1002\/acr.25690"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.1002795"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1016\/S2665-9913(19)30076-1"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1912196"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n71"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l4898"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2025.0056"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2024.0095"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1002\/art.70041"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-221478"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1002\/art.42392"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1002\/art.41598"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2025-006549"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.55563\/clinexprheumatol\/728zl6"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.1177\/09612033261441397"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.2024-0053"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-215882"}],"container-title":["Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/article-pdf\/doi\/10.1159\/000553444","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T16:00:54Z","timestamp":1786464054000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000553444"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,6]]},"references-count":21,"URL":"https:\/\/doi.org\/10.1159\/000553444","archive":["Portico"],"relation":{"is-supplemented-by":[{"id-type":"doi","id":"10.6084\/m9.figshare.32892974","asserted-by":"subject"}]},"ISSN":["0031-7012","1423-0313"],"issn-type":[{"value":"0031-7012","type":"print"},{"value":"1423-0313","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,6]]}}}