title: Comparison of tocilizumab as monotherapy or with add-on disease-modifying antirheumatic drugs in patients with rheumatoid arthritis and inadequate responses to previous treatments: an open-label study close to clinical practice.
abstract: This was an exploratory analysis comparing the safety and efficacy of tocilizumab monotherapy with those of tocilizumab in combination with disease-modifying anti-rheumatic drugs (DMARDs). Data were from a single-arm, nonrandomized, open-label, 24-week study in patients with rheumatoid arthritis in which patients with inadequate responses to DMARDs or tumor necrosis factor-α inhibitors received tocilizumab 8 mg/kg intravenously every 4 weeks plus methotrexate/other DMARD(s) combination therapy. If they were intolerant of methotrexate/other DMARD, patients received tocilizumab monotherapy. Effectiveness endpoints included American College of Rheumatology (ACR) responses (ACR20/50/70/90) and disease activity score using 28 joints (DAS28). Of 1,681 patients, 239 received tocilizumab monotherapy, and 1,442 received combination therapy. Methotrexate was the most common DMARD (79%) used in combination therapy. The frequency of adverse events (AEs), serious AEs, and AEs leading to withdrawal were similar between tocilizumab monotherapy (82.4, 7.9, and 5.4%, respectively) and combination therapy (76.6, 7.8, and 5.1%, respectively). No differences in ACR20/50/70/90 responses were observed between treatment groups (66.9%/43.5%/23.8%/10.0% vs 66.9%/47.2%/26.8%/8.5%, respectively; p > 0.12 for all individual comparisons, including ACR50 propensity score analyses). The decrease in DAS28 was also similar between treatment groups (mean ± standard deviation: -3.41 ± 1.49 for tocilizumab monotherapy vs -3.43 ± 1.43 for combination therapy; p > 0.33 all analyses, including propensity score analyses). Tocilizumab had a comparable safety profile, and was similarly effective, when used as monotherapy or in combination with DMARDs in a broad population of patients with rheumatoid arthritis.
authors.affiliation: Inflammatory Arthritis Center, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021, USA, bykerkv@hss.edu.
authors.forename: Vivian P
authors.initials: VP
authors.lastname: Bykerk
authors.forename: Andrew J K
authors.initials: AJ
authors.lastname: Östör
authors.forename: José
authors.initials: J
authors.lastname: Alvaro-Gracia
authors.forename: Karel
authors.initials: K
authors.lastname: Pavelka
authors.forename: José Andrés
authors.initials: JA
authors.lastname: Román Ivorra
authors.forename: Winfried
authors.initials: W
authors.lastname: Graninger
authors.forename: William
authors.initials: W
authors.lastname: Bensen
authors.forename: Michael T
authors.initials: MT
authors.lastname: Nurmohamed
authors.forename: Andreas
authors.initials: A
authors.lastname: Krause
authors.forename: Corrado
authors.initials: C
authors.lastname: Bernasconi
authors.forename: Maher
authors.initials: M
authors.lastname: Aassi
authors.forename: Jean
authors.initials: J
authors.lastname: Sibilia
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; C502936:tocilizumab