Background With the advent of biological therapy a range of new drugs have come available for patients with rheumatoid arthritis (RA). Tocilizumab (TCZ) was registered more recently for patients with RA. Obviously, data on long-term efficacy and safety in daily clinical practice is important as results obtained in short-term clinical registration trials might differ from those observed in long-term daily clinical practice.
Objectives To ascertain the efficacy of long- term TCZ treatment for RA
Methods From May 2009 to August 2014, 40 consecutive patients have been included in the TCZ RA cohort Patients were eligible for inclusion if disease activity was high despite previous treatment with TNF-inhibitor and in the absence of contraindications for the start of TCZ. TCZ was given, intravenously, in a dose of 8 mg/kg once every 4 weeks. Visits were performed regularly based on a fixed protocol. At every visits, disease activity was measured using Disease Activity Score of 28 joints (DAS28). Improvement after baseline as measured using the ΔDAS28. In addition, the Health Assessment Questionnaire was performed at baseline and half yearly thereafter. To investigate the course of DAS28 and improvement over time a t-test was used.
Results The mean age was 53 years (SD:18), and 29 (73%) were female. At baseline, the median disease duration was 9 (5-18) years, 29 (74%) were rheumatoid factor positive, 25 (66) had erosive disease, 29 (76%) were anti-CCP positive. At baseline, 22 (56%) used methotrexate (MTX), 24 (62%) used prednisolone, and 11 (28%) a DMARD other than MTX. On average patients had used 3.4 (SD:1.3) DMARDs, and 2.0 (0-3.0) biologicals. The maximum follow-up duration was 4.7 years, during which a total of 23 (58%) patients were stillon drug, and 17 (43%) patients have dropped out 8 patients (47%) due to adverse events, 7 patients (41%) stopped due to inefficacy, and 2 patients (12%) stopped for other reasons. The median follow-up duration was 0.48 (IQR:0.23-1.97) years for patients currently on TCZt, and 1.02 (0.25-1.96) years for drop-outs.
The mean DAS-28 dropped significantly from 5.3 (SD: 1.7) at baseline to 3.2 (1.3) at 12 weeks. This improvement sustained and increased further over 3 years, see figure. The mean score on the health assessment questionnaire (HAQ) dropped from 1.6 (0.7) to 1.3 (0.8) at 12 weeks of treatment, and remained stable after that, see figure.
Conclusions This cohort of RA patients treated with TCZ intravenously followed long term showed that the initial good response on tocilizumab persists for at least 3 years of follow-up based on DAS28 and HAQ, in patients who remained on TCZ treatment. 43% of patients dropped out during 5 years of follow-up.
Disclosure of Interest None declared