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From BLISS to ILLUMINATE studies: “Blys repetita placent”?
  1. Laurent Chiche1,
  2. Noémie Jourde-Chiche2,
  3. Frederique Retornaz1,
  4. Divi Cornec3
  1. 1Department of Internal Medicine, Hôpital Européen, Marseille, France
  2. 2Department of Nephrology, Aix-Marseille University, AP-HM, Hôpital Conception, UMR_S 1076, Vascular Research Center of Marseille, Marseille, France
  3. 3Service de Rhumatologie, CHRU Brest, and EA2216, INSERM ESPRI, ERI29, Université de Brest, Brest, France
  1. Correspondence to Dr Laurent Chiche, Department of Internal Medicine, Hôpital Européen, 6 rue désirée clary, Marseille 13006, France; l.chiche{at}

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Although disappointing, the results of the ILLUMINATE trials are read with great attention.1 ,2 These trials assessed the efficacy of tabalumab, a B lymphocyte stimulator (Blys) inhibitor, in systemic lupus erythematosus (SLE). Unfortunately, the results were not considered by Lilly worth following the development of this new agent, of the same therapeutic class than belimumab, the first biologic to be labelled in SLE.3 ,4 Overall, what retained our attention were the similarities between designs and results of ILLUMINATE and BLISS studies, while the fates of the two corresponding drugs were so different (table 1).

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Table 1

Phase III studies conducted in non-renal patients with SLE targeting Blys

Indeed, apart from slight differences in the design concerning the management of standard of care treatments, the inclusion of patients from different countries and the choice of a different cut-off for the outcome criteria, these four studies addressed large populations of patients with SLE with similar characteristics that were evaluated with the same composite outcome measure SLE Responder Index5 and showed only a modest (around 10%) response rate difference between active treatment and placebo. Notably, there were differences between the two ILLUMINATE studies as observed between the two BLISS studies (table 1). A significant …

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