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Safety and clinical activity of atacicept in the long-term extension of the phase 2b ADDRESS II study in systemic lupus erythematosus.
Wallace, Daniel J; Isenberg, David A; Morand, Eric F; Vazquez-Mateo, Cristina; Kao, Amy H; Aydemir, Aida; Pudota, Kishore; Ona, Victor; Aranow, Cynthia; Merrill, Joan T.
Afiliación
  • Wallace DJ; Division of Rheumatology, Cedars-Sinai Medical Center, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.
  • Isenberg DA; Centre for Rheumatology/Division of Medicine, University College London, London, UK.
  • Morand EF; Centre for Inflammatory Disease, Monash University, Melbourne, Australia.
  • Vazquez-Mateo C; Global Clinical Development.
  • Kao AH; Global Clinical Development.
  • Aydemir A; Global Biostatistics.
  • Pudota K; Global Biostatistics.
  • Ona V; Global Safety, EMD Serono Research and Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA.
  • Aranow C; Center for Autoimmunity, Musculoskeletal and Hematologic Diseases, Feinstein Institute for Medical Research, Manhasset, NY.
  • Merrill JT; Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA.
Rheumatology (Oxford) ; 60(11): 5379-5389, 2021 11 03.
Article en En | MEDLINE | ID: mdl-33547784
OBJECTIVES: Atacicept reduced SLE disease activity in the phase 2b ADDRESS II study, particularly in patients with high disease activity (HDA; SLEDAI-2K ≥10) at screening. We assessed long-term safety and efficacy of atacicept in the long-term extension (LTE) of ADDRESS II. METHODS: In the 24-week, randomized, double-blind, placebo-controlled ADDRESS II study, patients received weekly atacicept (75 or 150 mg) or placebo. Atacicept was continued at the same dose in atacicept-treated patients in the LTE; placebo-treated patients switched to atacicept 150 mg. Long-term safety was the primary endpoint. Secondary endpoints included SLE responder index (SRI)-4 and SRI-6 response rates and flares. RESULTS: In total, 253 patients entered the ADDRESS II LTE; 88 received atacicept 150 mg, 82 atacicept 75 mg and 83 placebo/atacicept 150 mg. Median active treatment duration in the LTE was 83.8 weeks. Frequencies of treatment-emergent adverse events (TEAEs) were similar across groups (90.4-93.2%), and 12.5%, 14.6% and 21.7% of patients in the atacicept 150 mg, atacicept 75 mg and placebo/atacicept 150 mg groups reported serious TEAEs during the treatment period. The proportions of patients with TEAEs leading to discontinuation were 5.7%, 4.9% and 10.8%, respectively. SRI-4 and SRI-6 response rates were maintained with atacicept in the modified intent-to-treat and HDA populations and those on continuous 150 mg had a reduced risk of first severe flare and longer time to first severe flare vs those who initially received placebo. CONCLUSION: Long-term treatment with atacicept 150 mg in SLE patients had an acceptable safety profile, with durable efficacy. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02070978.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas Recombinantes de Fusión / Lupus Eritematoso Sistémico Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Rheumatology (Oxford) Asunto de la revista: REUMATOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas Recombinantes de Fusión / Lupus Eritematoso Sistémico Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Rheumatology (Oxford) Asunto de la revista: REUMATOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido