IFN-α kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study

• Published in: Annals of the rheumatic diseases Vol. 79; no. 3; pp. 347 - 355
• Main Authors: Houssiau, Frederic A, Thanou, Aikaterini, Mazur, Minodora, Ramiterre, Edgar, Gomez Mora, Danny Alexis, Misterska-Skora, Maria, Perich-Campos, Risto Alfredo, Smakotina, Svetlana A, Cerpa Cruz, Sergio, Louzir, Bassem, Croughs, Thérèse, Tee, Michael Lucas
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.03.2020
• Subjects: Adrenal Cortex Hormones - administration & dosage; Adult; Antibodies; Autoantibodies - blood; Clinical trials; Corticosteroids; Double-Blind Method; Drug dosages; Female; Gene expression; Humans; Immunologic Factors - administration & dosage; Injections, Intramuscular; Interferon-alpha - administration & dosage; Interferon-alpha - immunology; Kinases; Lupus; Lupus Erythematosus, Systemic - blood; Lupus Erythematosus, Systemic - drug therapy; Lupus Erythematosus, Systemic - immunology; Male; Middle Aged; Monoclonal antibodies; Patients; Placebos; Prednisone; Safety; Severity of Illness Index; Steroids; Systemic lupus erythematosus; Treatment Outcome; Vaccines; Withholding Treatment - statistics & numerical data; α-Interferon; treatment; systemic lupus erythematosus; vaccination

ObjectiveTo evaluate the efficacy and safety of the immunotherapeutic vaccine interferon-α kinoid (IFN-K) in a 36-week (W) phase IIb, randomised, double-blind, placebo (PBO)-controlled trial in adults with active systemic lupus erythematosus (SLE) despite standard of care.MethodsPatients with SLE (1...