Tocilizumab a promising targeted therapy for systemic sclerosis patients
Tocilizumab may improve skin score and forced vital capacity (FVC) stabilization in patients with systemic sclerosis (SSc), while potentially increasing the risk of serious infections, according to the open-label data of the faSScinate* trial.
The double-blind trial included 87 SSc patients who had been randomized to receive tocilizumab (n=43) or placebo (n=44) for 48 weeks. In the open-label extension phase, all patients were given weekly 162 mg subcutaneous tocilizumab for another 48 weeks. The endpoints investigated were modified Rodnan Skin Score (mRSS) and percent predicted forced vital capacity (%pFVC) through week 96.
Overall, 24 (55 percent) patients in the placebo-tocilizumab arm and 27 (63 percent) in the continuous-tocilizumab arm completed treatment at week 96. Mean mRSS change from baseline was –3.1 with placebo and –5.6 with tocilizumab at week 48, and –9.4 in the placebo-tocilizumab arm and –9.1 in the continuous-tocilizumab arm at week 96.
At week 96, any decline in %pFVC was seen in 10 patients (42 percent) in the placebo-tocilizumab arm and 12 patients (46 percent) in the continuous-tocilizumab arm. None of the patients had >10 percent absolute decline in %pFVC.
In terms of safety, serious infection rates per 100 patient-years were 10.9 (3.0 to 27.9) with placebo and 34.8 (18.0 to 60.8) with tocilizumab during the double-blind phase by week 48, and 19.6 (7.2 to 42.7) in the placebo-tocilizumab arm and 0.0 (0.0 to 12.2) in the continuous-tocilizumab arm during the open-label phase by week 96.
The open-label data, together with the results from the first 48 weeks of double-blind treatment, from the faSScinate trial suggest that treatment with tocilizumab may yield benefits for skin fibrosis, lung fibrosis and physical function in patients with SSc, although the drug could increase the risk of serious infections, researchers said.
“Tocilizumab may be a promising targeted therapy for patients with progressive SSc who have few treatment options,” they added.
*Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis