Objectives To evaluate the effectiveness and safety of tocilizumab (TCZ) for the treatment of active RA in our department.
Methods Type of study: Prospective cohort. Inclusion criteria: RA-patients (new ACR-EULAR criteria) who have failed to at least one anti-TNF drug. Variables and Statistic: We evaluated the monthly changes of DAS28 and HAQ during the first year of treatment with TCZ using repeated measures ANOVA and survival of TCZ over the first 2 years with survival curves of Kaplan-Meier. Safety was assessed collecting adverse events, withdrawals due to safety and deaths.
Results We included 35 patients, 19 of them from clinical trials (88.6% women with a mean age of 55.3±11.1 years) with a total follow-up for 29.7 person-years, a median duration of disease of 10.0±7.3 years. Anti-CCP was positive in 22 patients (64%) and the rheumatoid factor in 31 (89%). Thirty-one (89%) had radiographic erosions and 1 patient had previous orthopedic surgery (arthroplasty of both knees). The number of previous DMARDs: 6 (17%) had received one, 11 (31%) two, 11 (31%) three, 1 (3%) four, 2 (5.7%) five, and one (3%) six DMARDs. The mean of DMARDs was 2.4±1.3 per patient. Twenty (60%) patients had taken MTX (mean dose 16.4±4.8 mg/week), 6 (17%) had received LF (mean dose 20mg/24 h) and 1 (3%) hydroxychloroquine (mean dose of 400mg/24 h). The number of previous biological therapies used was: 8 (22.9%) patients had received one, 13 (37%) two, 7 (20%) three and 6 (17%) four, which represented an average of 2, 3±1.0 per patient biologics.
The DAS28 improved progressively during the first year with TCZ (F =17.8; Trace Pilai p=0.008). Although the most significant change occurred in the first month (mean difference 1.9 (95% CI =0.4 to 3.3, p=0.002, Bonferroni adjustment p=0.010) after 1 year reached an estimated mean difference of 3.1 (95% CI =1.3 to 4.8, Bonferroni adjustment p=0.002).The HAQ also improved progressively with TCZ the first 3 months (F =3.5; Trace Pilai p=0.043), but in a much slower than the DAS28 [mean difference from baseline to third month in 0.436 (95% CI = - 0056 to -0929; Bonferroni adjustment p=0.103).
Twenty (57.1%) patients continued with treatment after a median of 18 months (CI 95% 11.7 to 24.2 months) which resulted in the suspension rates of 14%, 17% and 26% at 3, 6 and 12 months, respectively. The causes of withdrawal or abandonment of treatment with TCZ were: 2 (6%), infections (severe cellulitis, and conjunctivitis), 2 (6%) due to failure of efficacy, 3 (9%) for infusional reaction, 1 (3%) by asymptomatic neutropenia, 3 (9%) patient’s decision, 2 (6%) due to gastrointestinal intolerance and 1 (3%) for protocol violation. Of all dropouts, only 8 patients were withdrawn due to adverse effects (including the only serious case was a right lower limb cellulitis).
Conclusions In patients with RA who have previously failed other biologic therapies, TCZ produced a rapid improvement of inflammatory activity and physical function. The rate of discontinuation due to adverse events was relatively low for this subgroup of patients (23%), and serious adverse events were unusuals.
Disclosure of Interest None Declared
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.