Major reduction of ultrasound-detected synovitis during subcutaneous tocilizumab treatment: results from a multicentre 24 week study of patients with rheumatoid arthritis

Abstract

Objective: Few studies have investigated the efficacy of subcutaneous tocilizumab (TCZ-SC) on ultrasound-detected inflammation. This study aimed to explore the clinical efficacy of TCZ-SC treatment in rheumatoid arthritis (RA) patients and to evaluate the response by ultrasound compared to Composite Disease Activity Scores (CDAS).

Method: This open-label, single-arm study enrolled RA patients with inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs initiating TCZ-SC 162 mg once weekly for 24 weeks, with clinical assessments at baseline, 2, 4, 8, 12, 16, 20, and 24 weeks. Ultrasound examinations [semi-quantitative score (0–3) of 36 joints and four tendons] were performed at baseline, 4, 12, and 24 weeks. CDAS and American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) response, and sum scores of ultrasound grey scale/Doppler were calculated. Changes during follow-up were explored by the Mann–Whitney test and correlations by Spearman’s rho.

Results: In total, 133 patients (mean ± sd age 55.9 ± 12.0 years) were assessed clinically and 110 patients were also examined with ultrasound. All clinical and ultrasound scores decreased significantly after 4 weeks (p < 0.001). At 24 weeks there was EULAR good response in 87.7% and ACR 70% response in 47.4%. Ultrasound scores had no or low correlations with patient-reported outcomes. At 24 weeks, CDAS remission was achieved in 27.4–83.5% and a sum score Doppler of 0 was found in 53.3%.

Conclusions: Clinical and ultrasound scores decreased rapidly. Ultrasound scores were not associated with patient-reported variables. Half of the patients reached ultrasound remission, while there were large discrepancies in the percentage of patients reaching remission based on different CDAS.

Trial registration: Study ML28691, registered 28 January 2014, ClinicalTrials.gov identifier: NCT02046616

Acknowledgements

We want to give our warmest thanks to all the dedicated rheumatologists, study nurses, and other personnel working on this study.

This work was funded by F Hoffmann la Roche.

Disclosure statement

HBH has received fees for speaking and/or consulting from AbbVie, BMS, Pfizer, UCB, Roche, MSD, and Novartis. IMJH, PJ, MLR, and MZ declare no conflicts of interest. BA is affiliated to Roche. LT has received fees for speaking from Roche, MSD, BMS, Pfizer, AbbVie, Novartis, and Janssen.

Data availability statement

Data are available upon reasonable request. All data relevant to the study are included in the article.

Additional information

Funding

This work was supported by the Roche.