Background Tocilizumab is approved by the European Medicines Agency to treat rheumatoid arthritis (RA) and systemic-onset juvenile idiopathic arthritis (JIA).
Objectives To assess the efficacy and tolerability of tocilizumab in patients treated with tocilizumab in a single-centre.
Methods The prospective Leeds Biologics Database was searched to identify all patients that have received tocilizumab up to December 2011. Change in disease activity score (DAS28-ESR), EULAR response and HAQ-DI (Health Assessment Questionnaire-Disability Index) as well as reasons for cessation were recorded as part of the initial analysis.
Results Eighty patients (59 female, 21 male) have received tocilizumab providing data for 103 patient-years. Treatment indications include: RA (55), systemic-onset JIA (6), other JIA (10), adult-onset Still’s disease (5), seronegative spondyloarthropathy with peripheral arthritis (2) and other systemic inflammatory illness (2). Mean (SEM) baseline characteristics amongst the main diagnostic groups, RA and JIA patients respectively, were: age 54 (1.8) and 25 (1.4) years, disease duration of 15 (1.3) and 17 (1.7) years, number of prior biologic therapies (TNF-inhibitors, rituximab +/- abatacept) of 3 (0.2) and 2 (0.3); SJC 6 (0.7) and 4 (0.8), CRP 49 (9.6) and 44 (17) g/dL, DAS28-ESR 5.6 (0.1) and 5.0 (0.4) and HAQ-DI 1.9 (0.1) and 1.5 (0.2). Concomitant DMARD therapy was prescribed in 56 patients (70%), with 54/56 (96%) receiving methotrexate (1 hydroxychloroquine and 1 leflunomide). Tocilizumab was discontinued in 21 patients for the following reasons: adverse event (6), pregnancy (5), primary non-response (8) and secondary non-response (2). In addition, one patient died due to sepsis and one moved out of area, giving a total exposure of 103 patient-years. Adverse events requiring discontinuation, occurring at a rate of 0.06 per patient-year, were infusion reaction, neutropenia, hypogammaglobulinaemia, nausea, pneumonia and septic arthritis (1 patient each). Of patients continuing on tocilizumab, and reaching the respective timepoints, significant reduction in DAS28 score and HAQ-DI was observed (Table 1). Table 1 shows rates of EULAR response and DAS28 remission.
Conclusions This preliminary report describes single-centre experience with tocilizumab in a diverse patient population. Impressive remission rates were observed in a biologic resistant cohort with minimal adverse events necessitating discontinuation. Additional analysis on haematological and biochemical parameters in the different disease groups should provide further information on the value of tocilizumab in a real-world setting.
Disclosure of Interest S. Horton: None Declared, S. Das: None Declared, D. Bryer: None Declared, P. Emery Grant/Research support from: Bristol-Myers Squibb, Pfizer, Consultant for: Abbott, Roche, Bristol-Myers Squibb, Pfizer, M. Buch Grant/Research support from: Bristol-Myers Squibb, Pfizer, Consultant for: Abbott, Roche, Bristol-Myers Squibb