Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries

Tocilizumab (TCZ) is the first drug approved worldwide for the treatment of RA. The number of phase 3 studies such as SUMMACTA, BREVACTA and MUSASHI reported the efficacy of TCZ against RA. But there is a need to understand the efficacy and safety profile of TCZ-SC in the less stringent phase 4 clinical setting. Therefore this phase 4 TOZURA study confirmed the efficacy and safety profile of TCZ as monotherapy and in combination with csDMARDs.

The pooled analysis of the TOZURA study aimed to identify the safety and effectiveness of subcutaneous tocilizumab (TCZ-SC) as monotherapy or in combined therapy with csDMARDs among moderate to severe RA patients who were MTX naïve or who responded inadequately to anti-TNF agent or csDMARD.

The study is an open-label, phase 4, single-arm, multinational, common-framework programme which involved 1804 patients. The 162 mg TCZ-SC was given at the investigator's discretion as monotherapy or combined with a csDMARD each week for ⩾24 weeks. The immunogenicity, efficacy and safety of TCZ-SC were evaluated. The comparison between groups was assessed using propensity score-based matching.

A total of 1451 and 353, out of 1804 patients received combination therapy and monotherapy, respectively. Both groups exhibited a considerable reduction in 28-joint DAS using ESR (DAS28-ESR) without any noticed difference between groups. Also, the frequency of the patients who obtained the Clinical Disease Activity Index remission or ACR 20/50/70/90 or DAS28-ESR was similar among both groups. A total 13.9% of patients withdrew, out of which 1.6% due to insufficient therapeutic response; 5.8% due to one or more serious adverse events; 6.2% due to safety reasons along with six deaths.

This analysis recommended TCZ-SC's as a safe and efficient approach with favourable impacts both as mono and combined (with csDMARDs) therapy.