Session Information
Date: Sunday, November 8, 2015
Title: Rheumatoid Arthritis - Clinical Aspects I - Treatment Advances and Strategies
Session Type: ACR Concurrent Abstract Session
Session Time: 4:30PM-6:00PM
Background/Purpose:
An Austrian multi-center study of the effect on disease activity and the safety of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus TCZ Monotherapy in patients with mild to moderate rheumatoid arthritis (RA), with inadequate response to MTX – The OPTIMISE trial (EUDRACT No. 2011-001863-39)
As only limited data are available on the efficacy of biologicals in Rheumatoid Arthritis (RA) patients in mild to moderate disease activity, particularly with respect to Tocilizumab (TCZ), this study was performed to assess the influence on disease activity of TCZ+MTX versus TCZ-monotherapy in patients with mild to moderate RA.
Methods:
Seventy-seven patients with mild to moderate RA and an inadequate response (DAS28 < 4.5 and >2.6) to a stable dose of MTX (15 – 25 mg/wk) were enrolled into the first phase and received three infusions of TCZ (8 mg/kg) iv every 4 weeks + MTX. If the patients achieved a good/moderate EULAR response after 3 months they were randomized into group A (TCZ 8 mg/kg iv/mth plus MTX) or group B (TCZ 8 mg/kg iv/mth plus Placebo (PBO) MTX). The primary endpoint was the change in DAS28 score from week 12 (time of randomization) to week 24. Secondary endpoints were the proportion of patients achieving DAS28 remission, CDAI remission, SDAI remission and RADAI-5 remission at week 24 as well as the improvement in physical & mental health and satisfaction with treatment using different questionnaires.
Results:
Sixty-five patients (84.4%; 51 female/14male; mean age 57.5 +/- 11.3 yrs) achieved a EULAR response and were included into the blinded phase of the trial. The mean DAS28 (ITT-population) at wk 12 in the MTX group (n=32) was 1.51, and in the PBO group (n=33) 1.72. The change in DAS28 score from wk 12 to wk 24 was statistically not significant between group A and group B (0.17 ± 0.83 in the MTX group vs. -0.16 ± 1.13 in the PBO group (n = 33); 95% CI for the difference [-0.16; 0.82], p =0,188). All secondary endpoints, namely the proportion of patients in remission, improvement of function, mental health, and satisfaction with treatment proved to be statistically not significantly different between MTX or PBO treated patients. Regarding tolerability no new signals could be detected.
Conclusion:
Additional TCZ treatment led to significant improvement in patients with mild to moderate RA and an inadequate response to MTX. TCZ-Monotherapy was seen as effective as combination with MTX to preserve the level of disease activity achieved at wk12.
To cite this abstract in AMA style:
Leeb B, Lunzer R, Fasching P, Herold M, Zamani O, Graninger W. The Safety and Effect on Disease Activity of Tocilizumab in Combination with MTX Versus Tocilizumab Monotherapy in Patients with Mild to Moderate RA: An Attempt to Optimise the Treatment Response [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/the-safety-and-effect-on-disease-activity-of-tocilizumab-in-combination-with-mtx-versus-tocilizumab-monotherapy-in-patients-with-mild-to-moderate-ra-an-attempt-to-optimise-the-treatment-response/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-safety-and-effect-on-disease-activity-of-tocilizumab-in-combination-with-mtx-versus-tocilizumab-monotherapy-in-patients-with-mild-to-moderate-ra-an-attempt-to-optimise-the-treatment-response/