FDA approves tocilizumab for SSc-ILD
medwireNews: Tocilizumab has been approved by the US FDA for slowing the rate of decline in respiratory function in patients with systemic sclerosis (SSc)-associated interstitial lung disease (ILD).
Previously approved for a number of indications including rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, the interleukin-6 receptor inhibitor may now be given to adult patients with SSc-ILD at a dose of 162 mg once weekly by subcutaneous injection.
This expanded indication is based on findings from the phase 3 focuSSced trial, in which tocilizumab did not significantly improve skin fibrosis in patients with diffuse cutaneous SSc, but those treated with the agent had a significantly smaller decline in lung function than those given placebo.
The prescribing information for tocilizumab notes that the intravenous formulation has not been approved for SSc-ILD, and that dose interruption may be required for the management of laboratory abnormalities such as neutropenia, thrombocytopenia, and elevated liver enzymes.
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