Background Tocilizumab (TCZ) is a humanized monoclonal anti-interleukin-6 receptor antibody, used for the treatment of moderate to severe rheumatoid arthritis (RA). Although TCZ has been proved to be highly effective and safe in RA patients in large clinical trials, few data are available from real-life practice .
Objectives To evaluate efficacy, safety and retention rate of intravenous (IV) and subcutaneous (SC) TCZ in a real-world setting.
Methods We evaluated patients affected by moderate-to-severe RA and treated with TCZ from April 2010 to December 2015. Data of patients treated with IV-TCZ until December 2014 were collected retrospectively, while patients treated with either IV or SC-TCZ from January 2015 were included in a prospective cohort and assessed for disease activity, quality of life, treatment discontinuation and/or onset of adverse events (AEs). DAS28-CRP, CDAI and SDAI were used for activity assessment. Treatment retention rate was estimated by Kaplan-Meier method.
Results We evaluated 87 patients, 53 treated with IV-TCZ (8 mg/kg every 4 w), 12 with SC-TCZ (162 mg every week) and 22 patients who switched from IV to SC during follow-up (71 females, median age 61 y, median duration of disease 10 y, median follow-up 16 months). Sixty-six patients (76%) were treated in monotherapy and 21 (24%) in combination with methotrexate; 16 (18%) patients were naïve for previous biologic drugs.
At baseline, disease activity was severe in 36% of patients, moderate in 59% and mild or inactive in 5%; at month 6, 49% of patients achieved a clinical remission. The mean overall DAS28 was 4.72 at baseline and 2.61 at 6 months (p<0.001 for all comparisons between baseline and subsequent assessments, see Figure).
Thirty-three patients (38%) discontinued TCZ because of inefficacy (67%), AEs (24%) or other reasons (9%). Seventy-three infectious AEs occurred in 38 patients (45.1/100 person-years), 3 cases of pneumonia were severe and only one required treatment discontinuation. Other AEs were mild neutropenia (29%), mild hypertransaminasemia (22%), hypercholesterolemia (39%) and hypertriglyceridemia (10%). Infusion reactions were reported in 5/75 IV-TCZ patients, while injection site reactions in 8/34 SC-TCZ patients.
We observed an overall high retention rate (85.2%, 70.2%, 61.3%, 54.6%, 43.2% at 6, 12, 24, 48 and 60 months respectively); no significant difference was found between combination or monotherapy (p=0.58) or between IV or SC at 22 months (p=0.51). In multivariate Cox regression analysis longer duration of disease (HR 1.06, 95%CI 1.02–1.11), presence of ≥1 comorbidities (HR 2.25, IC95% 1.39–3.64) and previous treatment with ≥2 biologic drugs (HR 1.55, IC95% 1.04–2.31) were associated with treatment discontinuation.
Conclusions TCZ is effective, well tolerated and safe in a population of RA patients followed in a real-life setting.
Gabay C, Riek M, Hetland ML, Hauge EM, Pavelka K, Tomšič M, et al. Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a European collaborative study. Ann Rheum Dis. 2015 Sep 15.
Disclosure of Interest None declared