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10.1002/art.40425 http://scihub22266oqcxt.onion/10.1002/art.40425 C5947119!5947119 !29381843     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=29381843 &cmd=llinks): Failed to open stream: HTTP request failed! 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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 |pdf=|usr=}}{{29381843 }} gab.com Text 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 JO: Arthritis Rheumatol http://www.kidney.de/pget.php?&tw=1&pmid=29381843 #FOAvip 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 ?g/ml) versus the total EMBODY population (87.1 ?g/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. Twit Text FOAVip 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 ????Arthritis Rheumatol http://www.kidney.de/pget.php?&tw=1&pmid=29381843 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=29381843 #FOAvip English Wikipedia <ref>{{Cite pmid|29381843 }}</ref> 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 #MMPMID29381843 Gottenberg JE ; Dörner T ; Bootsma H ; Devauchelle-Pensec V ; Bowman SJ ; Mariette X ; Bartz H ; Oortgiesen M ; Shock A ; Koetse W ; Galateanu C ; Bongardt S ; Wegener WA ; Goldenberg DM ; Meno-Tetang G ; Kosutic G ; Gordon C Arthritis Rheumatol 2018[May]; 70 (5 ): 763-773 PMID29381843 show ga 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 ?g/ml) versus the total EMBODY population (87.1 ?g/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. |Adult [MESH] |Antibodies, Monoclonal, Humanized/*therapeutic use [MESH] |Antineoplastic Agents, Immunological/*therapeutic use [MESH] |B-Lymphocytes/immunology [MESH] |Case-Control Studies [MESH] |Clinical Trials, Phase III as Topic [MESH] |Female [MESH] |Humans [MESH] |Immunoglobulin A/immunology [MESH] |Immunoglobulin G/immunology [MESH] |Immunoglobulin M/immunology [MESH] |Lupus Erythematosus, Systemic/complications/*drug therapy/immunology [MESH] |Male [MESH] |Middle Aged [MESH] |Randomized Controlled Trials as Topic [MESH] |Sialic Acid Binding Ig-like Lectin 2/antagonists & inhibitors [MESH] |Sjogren's Syndrome/complications/*drug therapy/immunology [MESH]Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Syst(epmc).pdf DeepDyve Pubget Overpricing