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Abstract Number: 517

Real-World Use of Tocilizumab in Rheumatoid Arthritis Patients in Canada: Interim Results

Boulos Haraoui1, Shahin Jamal2, Vandana Ahluwalia3, Tarang Manchanda4 and Majed Khraishi5, 1Department of Medicine, Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada, 2Department of Rheumatology, University of British Columbia, Vancouver, BC, Canada, 3William Osler Health Center, Brampton, ON, Canada, 4Hoffmann-La Roche Canada, Mississauga, ON, Canada, 5Nexus Clinical Research, St John's, NF, Canada

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: combination therapies, rheumatoid arthritis, Rheumatoid arthritis (RA), treatment and tocilizumab

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Session Information

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.

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