medwireNews: Tocilizumab does not significantly improve skin fibrosis in patients with diffuse cutaneous systemic sclerosis (SSc) but may preserve lung function among individuals with early interstitial lung disease (ILD), say researchers.
“The potential effect of tocilizumab in preserving lung function in patients with early SSc-ILD in early systemic sclerosis has important therapeutic implications, including potential to prevent progression of a major disease complication,” write Dinesh Khanna (University of Michigan, Ann Arbor, USA) and co-authors in The Lancet Respiratory Medicine.
In their phase 3 focuSSced trial, Khanna and team randomly assigned 210 adults with diffuse cutaneous SSc (duration ≤5 years, modified Rodnan skin score [mRSS] of 10–35 units) to receive weekly subcutaneous treatment with the anti-interleukin-6 receptor antibody tocilizumab 162 mg (n=104) or placebo (n=106) for 48 weeks.
They found that mRSS fell from baseline to week 48 in both the tocilizumab and placebo groups, with least squares mean (LSM) changes of 6.14 and 4.41 units, respectively, but the difference between the two groups was not statistically significant.
By contrast, the LSM decline in lung function, as measured by change in percentage of predicted forced vital capacity (FVC) from baseline to week 48, was significantly smaller with tocilizumab versus placebo, at 0.4% versus 4.6%.
Khanna and co-authors point out that the stabilization of lung function that occurred among the participants who received tocilizumab was similar to the effect they observed in their phase 2 faSScinate trial, previously reported by medwireNews.
However, they warn that the “results for FVC and other secondary outcome measures should be interpreted with caution because the primary outcome [mRSS] was not statistically significant.”
In spite of this, they note that the effect on FVC is supported by two other randomized controlled trials and “shows a clinically meaningful effect on preservation of lung function.”
Among other secondary outcomes evaluated, treatment failure rates at 48 weeks were lower with tocilizumab than with placebo (22 vs 35%), but not significantly so, and there was no difference between the two groups in patient- or physician-reported outcomes on the Health Assessment Questionnaire-Disability Index, patient global assessment, or physician global assessment.
Khanna et al note that the safety profile was consistent with that already known for tocilizumab. The most common adverse event in both groups was infection, occurring among 52% of participants who received tocilizumab and 50% of those who received placebo.
Serious adverse events occurred at a rate of 13% in the tocilizumab arm and 17% in the placebo arm and were typically due to infections or cardiac events.
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