Long-Term Safety and Efficacy of Epratuzumab in the Treatment of Moderate-to- Severe Systemic Lupus Erythematosus: Results From an Open-Label Extension Study

Arthritis Care & Research
Daniel J WallaceCaroline Gordon

Abstract

The primary objective was to assess the long-term safety of repeated courses of epratuzumab therapy in patients with moderate-to-severe systemic lupus erythematosus. Secondary objectives were to assess long-term efficacy and health-related quality of life (HRQOL). Eligible patients from the 12-week, phase IIb, randomized, placebo-controlled EMBLEM study enrolled into the open-label extension (OLE) study, SL0008. In the SL0008 study, patients received 1,200 mg epratuzumab infusions at weeks 0 and 2 of repeating 12-week cycles, plus standard of care. Safety measures included treatment-emergent adverse events (TEAEs) and serious TEAEs. Efficacy measures included combined treatment response, the British Isles Lupus Assessment Group score, the Systemic Lupus Erythematosus Disease Activity Index score, and the physician's and patient's global assessment of disease activity. Total daily corticosteroid dose and HRQOL (by the Short Form 36 health survey) were also assessed. A total of 113 of the 203 patients (55.7%) who entered the SL0008 study continued epratuzumab therapy until study closure (total cumulative exposure: 381.3 patient-years, median exposure: 845 days, and maximum exposure: 1,185 days/approximately 3.2 years). TEAEs were...Continue Reading

References

Mar 25, 2000·Annals of the Rheumatic Diseases·G S DeanD A Isenberg
Feb 22, 2003·Hand Surgery : an International Journal Devoted to Hand and Upper Limb Surgery and Related Research : Journal of the Asia-Pacific Federation of Societies for Surgery of the Hand·Y TaniguchiM Yoshida
Feb 12, 2009·The Journal of Rheumatology·Mae ThamerMichelle Petri
Feb 26, 2010·Rheumatology·Chee-Seng YeeCaroline Gordon
Jun 4, 2010·Nature Reviews. Rheumatology·Iñaki Sanz, F Eun-Hyung Lee
Jan 12, 2011·British Journal of Clinical Pharmacology·Pawel Traczewski, Lidia Rudnicka
Nov 15, 2011·Arthritis Research & Therapy·Thomas DörnerPeter E Lipsky
Apr 7, 2012·Seminars in Arthritis and Rheumatism·Meenakshi JollyDaniel J Wallace
Oct 23, 2012·International Reviews of Immunology·Thomas DörnerKenneth G C Smith

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Citations

Jan 23, 2016·Annales de dermatologie et de vénéréologie·L Mouthon, B Chaigne
Apr 1, 2016·Expert Opinion on Biological Therapy·Mo Yin Mok, Yehuda Shoenfeld
Jun 17, 2016·Journal of Internal Medicine·A A Bengtsson, L Rönnblom
Jul 20, 2016·Rheumatic Diseases Clinics of North America·Gaetane NocturneXavier Mariette
Nov 12, 2016·The Journal of Allergy and Clinical Immunology. in Practice·Jolan E WalterMegan A Cooper
Mar 16, 2018·Expert Review of Clinical Immunology·Daniel Geh, Caroline Gordon
Oct 4, 2017·The Journal of Immunology : Official Journal of the American Association of Immunologists·Kyle J BednarMatthew S Macauley
Nov 5, 2017·Current Rheumatology Reports·Stamatis-Nick C Liossis, Chrysanthi Staveri
Feb 29, 2020·Immunological Medicine·Wen Shi Lee, Olga Amengual
Sep 12, 2019·Frontiers in Pediatrics·Ottavia Maria DelmonteLuigi Daniele Notarangelo
Aug 10, 2019·BioMed Research International·Dominik Samotij, Adam Reich
Feb 1, 2020·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Kalliopi KlavdianouAntonis Fanouriakis
Oct 28, 2020·Clinical Rheumatology·Qin Shao
Mar 10, 2021·The Cochrane Database of Systematic Reviews·Cora W HannonCathy Bennett

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