Effect of disease duration and other characteristics on efficacy outcomes in clinical trials of tocilizumab for rheumatoid arthritis
Open Access
- 26 August 2020
- journal article
- research article
- Published by Oxford University Press (OUP) in Rheumatology
- Vol. 60 (2), 682-691
- https://doi.org/10.1093/rheumatology/keaa259
Abstract
To determine the extent to which disease duration, alone or in combination with other baseline clinical and non-clinical factors, explains variations in outcome of tocilizumab initiated in biologic-naïve patients with established RA. In this pooled analysis of phase 3 and 4 clinical trials conducted by the sponsor, predictors of response, including demographics, disease characteristics at baseline (start of tocilizumab dosing) and study characteristics (e.g. patient inclusion criteria, tocilizumab dosing regimen) were evaluated. Response was measured as change from baseline to week 24 in Clinical Disease Activity Index (CDAI) and HAQ–Disability Index (HAQ-DI) scores and as the proportions of patients who experienced ≥50% improvement based on ACR criteria (ACR50) and CDAI remission (≤2.8) rates at week 24. Improvements in all outcomes investigated were observed in patients receiving tocilizumab. Although disease duration was statistically significant in the models, it accounted for <2% of variation in CDAI and HAQ-DI score changes from baseline to week 24; baseline CDAI and HAQ-DI values accounted for 32% and 15% of variations, respectively. Doubling of disease duration reduced the odds of achieving an ACR50 response by only 9%, and each additional 5-year period of disease duration decreased the odds of achieving CDAI remission by only 15%. RA duration, alone or in combination with other baseline characteristics, had a statistically significant but clinically small effect on the outcomes of tocilizumab initiated in biologic-naïve patients with established RA.Keywords
Funding Information
- F. Hoffmann-La Roche Ltd
This publication has 39 references indexed in Scilit:
- Longterm Safety and Efficacy of Tocilizumab in Patients with Rheumatoid Arthritis: A Cumulative Analysis of Up to 4.6 Years of ExposureThe Journal of Rheumatology, 2013
- Very early rheumatoid arthritis as a predictor of remission: a multicentre real life prospective studyAnnals Of The Rheumatic Diseases, 2012
- Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practiceAnnals Of The Rheumatic Diseases, 2012
- Efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis and a previous inadequate response to disease-modifying antirheumatic drugs: the ROSE studyAnnals Of The Rheumatic Diseases, 2011
- Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: Results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structuArthritis & Rheumatism, 2011
- Greater likelihood of remission in rheumatoid arthritis patients treated earlier in the disease course: Results from the Consortium of Rheumatology Researchers of North America registryArthritis Care & Research, 2011
- Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION studyAnnals Of The Rheumatic Diseases, 2009
- Interleukin‐6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease‐modifying antirheumatic drugs: The tocilizumab in combination with traditional disease‐modifying antirheumatic drug therapy studyArthritis & Rheumatism, 2008
- Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trialThe Lancet, 2008
- Factors predicting response to treatment in rheumatoid arthritis: The importance of disease durationArthritis & Rheumatism, 2000