{"id":29408,"date":"2025-12-21T04:47:00","date_gmt":"2025-12-20T20:47:00","guid":{"rendered":"https:\/\/csccm.org.cn\/?p=29408"},"modified":"2025-12-21T19:11:21","modified_gmt":"2025-12-21T11:11:21","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e6%b3%b0%e4%bb%96%e8%a5%bf%e6%99%ae%e6%b2%bb%e7%96%97%e7%b3%bb%e7%bb%9f%e6%80%a7%e7%ba%a2%e6%96%91%e7%8b%bc%e7%96%ae%e7%9a%843%e6%9c%9f%e4%b8%b4","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=29408","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1a\u6cf0\u4ed6\u897f\u666e\u6cbb\u7597\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\u76843\u671f\u4e34\u5e8a\u8bd5\u9a8c"},"content":{"rendered":"\n

ORIGINAL ARTICLE<\/a><\/p>\n\n\n\n

A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus<\/h1>\n\n\n\n

Ronald F.\u00a0van Vollenhoven,\u00a0Li\u00a0Wang,\u00a0Joan T.\u00a0Merrill,\u00a0et al<\/h3>\n\n\n\n

N Engl J Med\u00a02025;393:1475-1485<\/h3>\n\n\n\n

DOI: 10.1056\/NEJMoa2414719<\/h3>\n\n\n\n

Abstract<\/h2>\n\n\n\n

BACKGROUND<\/h3>\n\n\n\n

Telitacicept, a new dual inhibitor of the cytokines B-lymphocyte stimulator (BLyS) and APRIL (a proliferation-inducing ligand), showed efficacy in adults with active systemic lupus erythematosus (SLE) in a phase 2b trial when added to standard therapy.<\/p>\n\n\n\n

METHODS<\/h3>\n\n\n\n

We conducted a phase 3 trial in China in which participants with active SLE were randomly assigned (in a 1:1 ratio) to receive telitacicept (160 mg) or placebo subcutaneously once weekly for 52 weeks, in addition to standard therapy. The primary end point at week 52 was a response on the modified SLE Responder Index 4 (SRI-4), with a response on this composite measure defined as a reduction of at least 4 points in the Safety of Estrogens in Lupus Erythematosus National Assessment\u2013Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score (ranging from 0 to 105, with higher scores indicating greater disease activity), no new disease activity as measured on the British Isles Lupus Assessment Group index, and no worsening in the Physician\u2019s Global Assessment score.<\/p>\n\n\n\n

RESULTS<\/h3>\n\n\n\n

Of 433 adults screened, 335 underwent randomization (167 to the telitacicept group and 168 to the placebo group). At week 52, significantly more participants receiving telitacicept had a response on the modified SRI-4 than those receiving placebo (67.1% vs. 32.7%; adjusted difference, 34.5 percentage points; 95% confidence interval [CI], 24.3 to 44.7; P<0.001). A reduction of at least 4 points from baseline in the SELENA-SLEDAI score had occurred in 70.1% of the telitacicept group and in 40.5% of the placebo group (difference, 29.6 percentage points; 95% CI, 13.1 to 46.1). Adverse events that were considered by the investigator to be related to the trial regimen were more common with telitacicept than with placebo (74.9% vs. 50.0%). Such events that occurred more frequently in the telitacicept group than in the placebo group included upper respiratory tract infection (31.7% vs. 19.0%), a reduced serum IgG level (15.6% vs. 1.2%), a reduced serum IgM level (15.0% vs. 0.6%), and injection-site reactions (12.6% vs. 0.6%).<\/p>\n\n\n\n

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CONCLUSIONS<\/h3>\n\n\n\n

In this 52-week trial involving participants with active SLE who were receiving background therapy, the incidence of a clinical response was higher with telitacicept than with placebo. However, the incidence of upper respiratory infections, reduced immunoglobulin levels, and injection-site reactions was also higher with telitacicept. (Funded by RemeGen; 18C010 ClinicalTrials.gov number, NCT04082416<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE A Phase 3 Trial of Telitacicept for Sy […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/29408"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=29408"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/29408\/revisions"}],"predecessor-version":[{"id":29410,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/29408\/revisions\/29410"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=29408"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=29408"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=29408"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}