The Food and Drug Administration (FDA) has approved Actemra® (tocilizumab; Genentech) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Approval for the new indication is based on data from the phase 3 multicenter, randomized, double-blind, placebo-controlled focuSSced trial (ClinicalTrials.gov: NCT02453256) which evaluated Actemra in systemic sclerosis. Of the 212 adults enrolled, 68 patients in the Actemra group and 68 in the placebo group had SSc-ILD at baseline. The primary efficacy end point was change from baseline at week 48 in the modified Rodnan Skin Score (mRSS). Change from baseline in forced vital capacity (FVC) at week 48 was a key secondary end point. Supportive data was also used from the faSScinate trial, a phase 2/3 randomized, double-blind, placebo-controlled study in patients with systemic sclerosis.

Results from the focuSSced study showed that the trial did not meet its primary end point of change from baseline to week 48 in the mRSS (mean change of -5.88 vs. -3.77 for Actemra and placebo respectively, mean difference -2.11). However, patients in the Actemra-treated group had less decline from baseline to week 48 in observed FVC and percent predicted forced vital capacity (ppFVC) compared to placebo.

The ppFVC and FVC results in the overall population were primarily driven by results in the SSc-ILD subgroup. In that subgroup, patients in the Actemra group had a smaller decline in mean ppFVC than the placebo patients (0.07% vs. -6.4%, mean difference 6.47%), and a smaller decline in FVC compared to placebo (mean change -14mL vs. -255mL, mean difference 241mL). Similar results in the mRSS and FVC were observed in the faSScinate trial.


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The safety profile of Actemra through week 48 in the focuSSced study was consistent with its known profile, which includes a Boxed Warning for the risk of serious infections.

Actemra, an interleukin-6 (IL-6) receptor antagonist, is also indicated for the treatment of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs, giant cell arteritis in combination with a tapering course of glucocorticoids, and active systemic juvenile idiopathic arthritis or active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

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Reference

Genentech’s Actemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease, a rare, debilitating condition. [press release]. San Francisco, CA: Genentech; March 4, 2021.