Date: Friday, November 6, 2020
Session Title: Systemic Sclerosis & Related Disorders – Clinical Poster I
Session Type: Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: The anti–interleukin-6 (IL-6) receptor-α antibody tocilizumab (TCZ) demonstrated skin score improvement and forced vital capacity (FVC) preservation in patients with systemic sclerosis (SSc) in a phase 2 randomized controlled trial.1,2 Data from the 48-week, double-blind (DB), placebo (PBO)-controlled period of the focuSSced phase 3 trial were previously presented,3 and open-label (OL) data up to week 96 are presented to assess the long-term safety and efficacy of TCZ in SSc patients.
Methods: Adult patients with active SSc (≤60-month duration, modified Rodnan skin score [mRSS] 10-35, and elevated acute-phase reactants) treated with PBO or TCZ in the DB period received OL TCZ 162 mg SC weekly from weeks 48 to 96 in the OL period (PBO→OL TCZ and TCZ→OL TCZ, respectively). Exploratory analysis of data up to week 96 included no formal statistical analyses. Changes in mRSS and percent predicted FVC (ppFVC) were assessed. The study was conducted in accordance with the principles of the Declaration of Helsinki and received IRB approval.
Results: Overall, 92 of 105 TCZ (88%) and 89 of 107 PBO (83%) patients entered the OL TCZ treatment period at week 48, and 85 of 105 TCZ→OL TCZ (81%) and 82 of 107 PBO→OL TCZ (77%) patients completed treatment up to week 96. Continued decline in mRSS was observed in the OL period for PBO→OL TCZ and TCZ→OL TCZ patients (Table). Change in ppFVC for patients who switched from PBO to TCZ (PBO→OL TCZ) was comparable between weeks 48 and 96 (OL period) to the change in patients who received TCZ from BL to week 48 in the DB period (Table). Rates (95% CI) of serious adverse events from weeks 48 to 96 were 15.8 (8.6, 26.5) per 100 PY for TCZ→OL TCZ patients, 14.8 (7.9, 25.3) per 100 PY for PBO→OL TCZ patients, and 15.4 (11.0, 20.9) for all-TCZ exposure over 96 weeks (n = 193). Rates (95% CI) of serious infections were 2.3 (0.3, 8.1) per 100 PY for TCZ→OL TCZ patients, 3.4 (0.7, 10.0) per 100 PY for PBO→OL TCZ patients, and 3.0 (1.3, 5.9) for all TCZ exposure over 96 weeks. One death occurred during the OL period in each arm (TCZ→OL TCZ, pulmonary hypertension; PBO→OL TCZ, brain injury).
Conclusion: Although OL data have to be interpreted with caution, results from OL TCZ treatment show numeric improvements in mRSS and FVC preservation similar to those of the DB period, with a beneficial effect on trajectory of FVC decline in patients who switched from PBO to TCZ. Long-term safety results were consistent with the known safety profile of TCZ, and no new or unexpected events were observed.
1. Khanna D et al. Lancet 2016;387:2630-40; 2. Khanna D et al. Ann Rheum Dis. 2018;77:212-20; 3. Khanna D et al. Arthritis Rheumatol 2018;70(suppl 10). Abstract 898.
To cite this abstract in AMA style:Khanna D, Lin C, Spotswood H, Siegel J, Furst* D, Denton C. Safety and Efficacy of Subcutaneous Tocilizumab in Systemic Sclerosis: Results from the Open-Label Period of a Phase 3 Trial [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/safety-and-efficacy-of-subcutaneous-tocilizumab-in-systemic-sclerosis-results-from-the-open-label-period-of-a-phase-3-trial/. Accessed September 19, 2021.
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