Efficacy of Epratuzumab, an Anti‐CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjögren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Issue 5 (12th April 2018)

• Record Type: Journal Article
• Authors: Gottenberg, Jacques‐Eric; Dörner, Thomas; Bootsma, Hendrika; Devauchelle‐Pensec, Valérie; Bowman, Simon J.; Mariette, Xavier; Bartz, Holger; Oortgiesen, Marga; Shock, Anthony; Koetse, Willem; Galateanu, Catrinel; Bongardt, Sabine; Wegener, William A.; Goldenberg, David M.; Meno‐Tetang, Guy; Kosutic, Gordana; Gordon, Caroline
• Is Part Of: Arthritis & rheumatology. Volume 70:Issue 5(2018)
• Page Start: 763
• Page End: 773
• Publication Date: 2018-04-12
• Subjects: Arthritis -- Periodicals; Rheumatism -- Periodicals; 616.72
• DOI: 10.1002/art.40425
• Languages: English
• ISSNs: 2326-5191

Abstract

Abstract : Objective: EMBODY 1 (ClinicalTrials.gov identifier: NCT01262365) and EMBODY 2 (ClinicalTrials.gov identifier: NCT01261793) investigated the efficacy and safety of epratuzumab, a CD22‐targeted humanized monoclonal IgG antibody, in patients with systemic lupus erythematosus (SLE). The studies showed no significant difference from placebo in primary or secondary clinical outcome measures but did demonstrate B cell–specific immunologic activity. The aim of this post hoc analysis was to determine whether epratuzumab had a different clinical efficacy profile in SLE patients with versus those without an associated diagnosis of Sjögren's syndrome (SS). Methods: The efficacy and safety of epratuzumab were compared between 2 patient subpopulations randomized in EMBODY 1 and 2: SLE patients with and those without a diagnosis of associated SS. British Isles Lupus Assessment Group (BILAG) total score, BILAG‐based Combined Lupus Assessment (BICLA) clinical response to treatment, biologic markers (including B cells, IgG, IgM, and IgA), and safety were assessed. Results: A total of 1, 584 patients were randomized in the EMBODY 1 and EMBODY 2 trials; 113 patients were anti‐SSA positive and had a diagnosis of associated SS, and 1, 375 patients (86.8%) had no diagnosis of associated SS (918 patients were randomized to receive epratuzumab and 457 to receive placebo). For patients with associated SS, but not those without associated SS, a higher proportion of patients receiving epratuzumab achieved a BICLA response and a reduction from baseline in BILAG total score. B cell reduction was faster in patients with associated SS. The sensitivity of B cells to epratuzumab as measured by the mean concentration producing 50% of the maximum B cell count depletion was lower for patients with associated SS (9.5 μg/ml) versus the total EMBODY population (87.1 μg/ml). No difference in the frequency of adverse events in those receiving placebo was reported. Conclusion: Patients with SLE and associated SS treated with epratuzumab showed improvement in SLE disease activity, which was associated with bioactivity, such as decreases in B cell number and IgM level.