Tocilizumab Effectiveness After Switching from Intravenous to Subcutaneous Route in Patients with Rheumatoid Arthritis: The RoSwitch Study

Abstract

Introduction The main objective of this work was to assess the maintenance of effectiveness of subcutaneous tocilizumab 6 months after switching from intravenous to subcutaneous formulation in patients with rheumatoid arthritis (RA) in a real-world setting. Secondary objectives aimed to describe the characteristics of patients and disease, the effectiveness at 12 months after switching, the therapeutic maintenance, and to search for predictive factors of switching. Methods We analyzed all the RA patients of the shared medical file “RIC Nord de France”, treated with tocilizumab, switching or not from intravenous to subcutaneous tocilizumab, between April 2015 and January 2016. The primary effectiveness endpoint was the proportion of patients remaining in their DAS28-ESR category remission/low disease activity (LDA) or moving to an inferior DAS28-ESR category at 6 months. Since RoSwitch was an observational study, without randomization, a propensity score was built in a sensitivity analysis to balance on RA and patients’ characteristics at inclusion between switching and no-switching groups. Results An improvement of initial DAS28-ESR category or maintenance in DAS28-ESR remission/LDA at 6 months was shown in 203 of the 285 patients with an evaluation for the primary criterion (71.2%, 95% CI [65.6–76.4%]) without differences between groups (73.3%, 95% CI [63.0–82.1%] vs. 70.3%, 95% CI [63.3–76.6%]). The RoSwitch study showed the maintenance of effectiveness at 6 and 12 months. Similar therapeutic maintenance rates were observed for switch and no-switch patients. No clinical factor was associated with the switch in patients in remission/LDA at inclusion. Conclusions The RoSwitch study showed the maintenance of effectiveness at 6 months in RA patients switching from intravenous (IV) to subcutaneous (SC) tocilizumab. Funding Roche SAS and Chugai Pharma France. Electronic supplementary material The online version of this article (10.1007/s40744-018-0138-y) contains supplementary material, which is available to authorized users.

Real-World 1-Year Retention Rate of Subcutaneous Tocilizumab Treatment in Patients with Moderate to Severe Active Rheumatoid Arthritis: TANDEM Study

“…No differences were observed either according to the use of TCZ-SC (MONO vs. COMBO, p = 0.725), patient age (± 65 years, p = 0.698), nor the weekly dose of MTX. Regarding BMI, although it might be due to the number of patients, no significant relation was observed with TCZ-SC drug retention (± 30 kg/m 2 , p = 0.496) as previously shown for effectiveness and body weight in non-interventional studies conducted in patients with RA switching from IV to SC formulations of TCZ [ 27 , 28 ]. Finally, no differences were observed between patient subgroups, indicating that the treatment duration of TCZ-SC, understood as an “indicator” of TCZ-SC effectiveness, is independent from patient characteristics and drug use.…”

Therapeutic Maintenance of Baricitinib and Tofacitinib in Real Life

“…Another study about tocilizumab in 2017 showed a therapeutic maintenance of 82.9%, and another study about infliximab in 2008 showed a therapeutic maintenance of 78% [ 14 , 15 , 16 ]. We can also quote a study of 2019 that compared therapeutic maintenance for tocilizumab at 12 months between patients treated by intravenous tocilizumab (80%) and patients who switched for subcutaneous tocilizumab (77.7%) [ 17 ].…”

Subcutaneous tocilizumab for active thyroid eye disease refractory to orbital radiation and systemic steroids in tobacco smokers

“…A prior study that switched patients from TCZ-IV to SC-TCZ found that patients appreciated the fewer time constraints and greater autonomy with self-administration. [ 15 ] In the face of public health concerns surrounding COVID-19, a significant advantage of SC-TCZ is that time spent in health-care facilities can be minimized. In addition, there are significant cost savings with SC-TCZ compared to other promising immunomodulatory drugs.…”