Session Information
Session Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Safety of Biologics and Small Molecules in Rheumatoid Arthritis
Session Type: Abstract Submissions (ACR)
Background/Purpose Tocilizumab (TCZ) has been approved for the treatment of adults with rheumatoid arthritis (RA) either as monotherapy or as combination with disease-modifying antirheumatic drugs (DMARDs). However, to date, data on its real-world utilization and durability are limited. The aim of this analysis is to describe the pattern of TCZ use at baseline (BL) and after 6 months (mos) of treatment in Canadian patients enrolled in ACT-UP, a multi-national observational study in moderate-to-severe RA patients treated with TCZ.
Methods ACT-UP is an ongoing, multi-national, observational study with TCZ. As of June 2014, 1,375 patients have been enrolled from 14 countries. In this analysis, data from the 200 Canadian patients participating in ACT-UP were used. Descriptive statistics were produced and between-group comparisons were performed with the independent samples t-test (continuous variables) and the chi-square test (categorical variables).
Results
Among the 200 patients included, 67 (33.5%) started TCZ as monotherapy and 133 (66.5%) in combination with DMARD(s) (mean methotrexate dose: 19.9 mg/week). BL age (55.2 vs 55.6 years, respectively), gender (79.1% vs 80.5% females) and disease duration (13.8 vs 12.0 years) were similar in the two groups. No difference in the initial TCZ dose was observed between groups with 91.0% in each receiving 8 mg/kg and the remaining receiving <8 mg/kg. Similarly, concomitant use at BL of a corticosteroid (38.8% vs 36.1%; mean prednisone dose: 10.7 vs 9.2 mg/day) and prior exposure to a biologic (80.6% vs 82.0% in monotherapy vs combination therapy) were also comparable in TCZ monotherapy vs combination therapy. Lack of efficacy (70.4% vs 68.2%) and intolerance (12.2% vs 10.9%) were the most common reasons for stopping a previous biologic in both treatment groups. However, a significantly higher proportion of patients in the monotherapy group had been previously treated with >1 traditional DMARD (90.8% vs 66.9%; P<0.001). Overall, BL disease parameters were statistically comparable between treatment groups with the exception of patient global assessment which was significantly higher in the TCZ monotherapy group (68.1 vs 60.6 mm; P=0.017).
Upon 6 mos of treatment, 86.6% of patients in the monotherapy group and 85.0% in the combination therapy group were still on TCZ. Over that period no change in TCZ dose was reported in 80.6% patients (76.9% vs 82.5% in mono- vs combination therapy), while the TCZ dose was down-titrated in 14.7% patients (18.5% vs 12.7%, respectively). Seven of 67 (10.4%) patients in the TCZ monotherapy group added a concomitant DMARD to TCZ within 6 mos. Regardless of treatment group significant improvements were observed over 6 mos in all disease parameters examined (BL vs 6 mos DAS28: 5.3 vs 3.4; P<0.001).
Conclusion
In this real-world observational study, TCZ was used as monotherapy in 33.5% of patients. Despite the fact that 81.5% of patients had been previously treated with a biologic, more than 85% of patients remained on TCZ treatment after 6 mos of treatment. TCZ treatment alone or in combination with DMARD(s) over 6 mos was effective in inducing significant improvements in all disease parameters studied.
Disclosure:
B. Haraoui,
AbbVie,
2,
AbbVie,
5,
Amgen,
2,
Amgen,
5,
Bristol-Myers Squibb,
2,
Bristol-Myers Squibb,
5,
Janssen Pharmaceutica Product, L.P.,
2,
Janssen Pharmaceutica Product, L.P.,
5,
Pfizer Inc,
2,
Pfizer Inc,
5,
Roche Pharmaceuticals,
2,
Roche Pharmaceuticals,
5,
UCB,
2,
UCB,
5;
S. Jamal,
AbbVie, Amgen, BMS, Roche, Merck, Pfizer, and UCB,
6;
V. Ahluwalia,
None;
T. Manchanda,
Hoffmann-La Roche Canada,
3;
M. Khraishi,
Roche Canada,
2.
« Back to 2014 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/real-world-use-of-tocilizumab-in-rheumatoid-arthritis-patients-in-canada-interim-results/