{"id":5632,"date":"2025-10-20T16:23:38","date_gmt":"2025-10-20T22:23:38","guid":{"rendered":"https:\/\/allphasepharma.com\/dir\/?p=5632"},"modified":"2025-10-21T17:16:04","modified_gmt":"2025-10-21T23:16:04","slug":"telitacicept-in-sle","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2025\/10\/20\/5632\/telitacicept-in-sle\/","title":{"rendered":"TELITACICEPT IN SLE"},"content":{"rendered":"

\"\"<\/a>In today\u2019s blog we will share our thoughts about a recent NEJM article, entitled \u201cA Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus\u201d.[1]<\/a><\/p>\n

Publications on SLE literally come with a book of abbreviations and definitions nowadays and are not an easy Sunday reads.\u00a0 Of course, there is extensive literature on the details of outcome measures which are a prerequisite to understanding the various scores and scales.\u00a0 No wonder that SLE specialists are needed as study consultants, esp. if they sit on Guidelines Committees and follow the design minutiae.<\/p>\n

As a dual inhibitor of BLyS and APRIL, the \u2018tacicept\u2019 group of drugs expands on the B-cell targeting of belimumab, a mAb with only BLyS blocking activity, which made it to approval after a haranguing series of studies with borderline activity in SLE.\u00a0 Hence, using a drug with broader anti-B-cell activity that includes autoantibody-producing plasma cells sounds like a reasonable approach.[2]<\/a>\u00a0 The expectation would be that results would at least confer the efficacy of belimumab, but hopefully much more.<\/p>\n

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LE or Hargraves cell<\/figcaption><\/figure>\n

Telitacicept had an interesting development history.\u00a0 It is the most advanced of the 3 \u2018tacicepts\u2019 (atacicept, telitacicept, and povetacicept); it is already approved in China for several indications.\u00a0 To everyone\u2019s surprise, the drug garnered NMPA provisional approval for SLE in 2021 based on a rather small set of interim data from a Phase 2 dose-finding trial conducted in China.\u00a0 Once published in full 2 years later, we learned further details: with approx. 60 patients per arm, the response rate of the SLE Responder Index (SRI-4) was 68.3% in the 160 mg Telitacicept group and 33.9% in the placebo group. \u00a0Of note, looking only at the SLEDAI component, the response rates were 78% for telitacicept and 50% in the placebo group. RemeGen is pursuing a few more indications for telitacicept.\u00a0 In 2025, it garnered additional approval for gMG.<\/p>\n

While we don\u2019t know the FDA’s position on telitacicept and its approvability for SLE, we can assume that the Phase 2 data would not suffice for approval, for various reasons.\u00a0 So, we assumed that a larger global Phase 3 trial would be a logical next step.<\/p>\n

Surprisingly, the Phase 3 study just published in the NEJM was conducted only at Chinese centers.\u00a0 With a prominent European rheumatologist as lead author, and a US clinical researcher listed as advisor and co-author, we had expected a pivotal multi-center international Phase 3 trial with at least some patients from Amsterdam and Oklahoma City.\u00a0 This was not the case here: RemeGen, a Chinese company chose to enroll the entire trial exclusively in China.<\/p>\n

This raises some flags about the applicability of the results to a non-Han Chinese population.\u00a0 On the positive side, RemeGen will not have to struggle explaining ethnic sensitivity issues to their local Authorities in China.<\/p>\n

So, what were the contributions of the expert consultants?\u00a0 The article mentions that \u201cRemeGen (the trial sponsor) and the last\u00a0<\/span>author designed the trial.\u201d\u00a0 In that case, what was the role of the first author, Prof. Vollenhoven, in all of this?\u00a0 He certainly did not write the manuscript; this was done with the help of a duo of professional ghost writers.<\/p>\n

The NEJM tells us that \u2018Ronald F. van Vollenhoven and Li Wang contributed equally to this article.\u2019\u00a0\u00a0 Okay, that indicates good hard intellectual work.\u00a0 We also are informed that<\/p>\n