ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2610

Real-World Use of Tocilizumab in Rheumatoid Arthritis Patients: Cardiovascular Risk, Concomitant Treatment, and Outcomes over 6 Months of Follow-up

Boulos Haraoui1, Shahin Jamal2, Vandana Ahluwalia3, Tarang Manchanda4 and Majed M. Khraishi5, 1Institut de Rhumatologie de Montréal and University of Montreal, Montreal, QC, Canada, 2Vancouver Coastal Health, Vancouver, BC, Canada, 3Brampton Civic Hospital, Brampton, ON, Canada, 4Hoffmann-La Roche Canada, Mississauga, ON, Canada, 5Nexus Clinical Research, St Johns, NF, Canada

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords:

Session Information

Date: Tuesday, November 10, 2015

Title: Rheumatoid Arthritis - Clinical Aspects Poster Session III

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Tocilizumab (TCZ) is approved for the treatment of adults with rheumatoid arthritis (RA) either as monotherapy or in 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 was to describe its real life use over 6 months and assess its safety in Canada.

Methods: ACT-UP CARE (ACT-UP Canadian Physician Observance of RA Patients on TCZ [CARE]) is an ongoing, multi-national, observational study with TCZ. As of January 2015, 1,432 patients have been enrolled from 18 countries. In this analysis, data from the 200 Canadian patients participating in ACT-UP are presented. The Framingham Cardiovascular (CV) Risk Score (FCRS) was measured at baseline (BL) as an exploratory assessment. Within-group changes in disease parameters were evaluated with the paired-samples t-test. Safety was described with the incidence of adverse events (AEs).

Results: The mean (SD) RA disease duration was 12.6 (10.4) years, and 79% of patients were on a previous biologic. Low, moderate and high FCRS category was reported for 52.6%, 36.8%, and 10.5%, respectively, of patients with available data. The most frequent CV risk factors were hypertension (36.7%), hyperlipidemia (21.6%), and current smoking (18.6%). Concomitant methotrexate (MTX) use was reported for 51.5% of patients at BL (mean dose: 19.5 mg/week) and 57.7% of patients over 6 months of treatment (mean dose: 18.7 mg/week). Corticosteroid use was reported for 40.5% of patients at BL (mean prednisone dose: 10.8 mg/day).  Among patients on prednisone at BL, stable dose was reported for 50.6%, decreased dose for 22.8%, increased dose for 10.1%, and steroid discontinuation for 16.5% over 6 months.  Mean (SD) disease and lipid parameters at BL and 6 months are shown in Table 1.

There were 20 (10.0%) discontinuations due to: AEs (n=6), lack of efficacy (n=5), withdrawal of consent (n=5), other (n=3), and death (n=1), without any significant differences based on prior use of a biologic (10.8% for bio-experienced vs. 7.1% for bio-naïve; P=0.772) and presence of comorbidities (8.7% for presence vs. 17.9% for no presence; P=0.168). A total of 351 AEs were reported by 144 (72.7%) patients (353.0 events /100 PYs), the majority of which (93.4%) were non-serious. Most frequently reported AEs included upper respiratory tract infection (n=14, 7.1%), headache (n=9, 4.5%), and fatigue (n=8, 4.0%). Serious infections were reported by 5 (2.5%) patients. One death due to pneumonia was reported which was judged by the treating physician as not related to TCZ. 

 Conclusion: The results of this real-world Canadian study show that TCZ is well tolerated and effective in significantly improving clinical parameters and patient reported outcomes as early as 6 months of treatment. 

Table 1: Disease and Lipid Parameters over 6 Months

 

Baseline

Month 6

P-Value

Disease Parameter, Mean (SD)

 

 

 

CRP: mg/L

19.8 (37.4)

4.3 (9.1)

<0.001

SJC

9.4 (5.2)

3.5 (4.4)

<0.001

TJC

12.6 (7.1)

4.6 (5.9)

<0.001

DAS28

5.6 (1.2)

2.9 (1.5)

<0.001

DAS28 Remission*

3 (1.6)

54 (41.5)

<0.001

AM Stiffness: minutes

58.4 (22.9)

38.7 (26.6)

<0.001

Patient Global (PtGA): VAS mm

62.5 (21.4)

41.2 (25.5)

<0.001

Pain: VAS mm

63.3 (22.9)

39.8 (27.6)

<0.001

Fatigue: VAS mm

62.8 (24.3)

43.8 (28.3)

<0.001

Lipid Parameter, Mean (SD)

 

 

 

Total Cholesterol: mmol/L

4.8 (1.1)

5.1 (1.1)

0.294

LDL-C: mmol/L

2.7 (0.9)

3.0 (0.8)

0.315

HDL-C: mmol/L

1.6 (0.8)

1.8 (0.7)

0.073

Triglycerides: mmol/L

1.4 (1.1)

1.3 (0.9)

0.548

Total Cholesterol/HDL-C Ratio

3.4 (1.4)

3.3 (1.2)

0.225

*Proportions are based on total number of patients with available data

Disclosure: B. Haraoui, AbbVie, Amgen, Bristol-Myers-Squibb, Celgene, Janssen Pharmaceutica Product, L.P., Pfizer Inc, Roche Pharmaceuticals, UCB, 2,AbbVie, Amgen, Bristol-Myers-Squibb, Celgene, Janssen Pharmaceutica Product, L.P., Pfizer Inc, Roche Pharmaceuticals, UCB, 5; S. Jamal, None; V. Ahluwalia, None; T. Manchanda, None; M. M. Khraishi, Janssen Inc., 5.

To cite this abstract in AMA style:

Haraoui B, Jamal S, Ahluwalia V, Manchanda T, Khraishi MM. Real-World Use of Tocilizumab in Rheumatoid Arthritis Patients: Cardiovascular Risk, Concomitant Treatment, and Outcomes over 6 Months of Follow-up [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/real-world-use-of-tocilizumab-in-rheumatoid-arthritis-patients-cardiovascular-risk-concomitant-treatment-and-outcomes-over-6-months-of-follow-up/. Accessed .

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