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Open-Label Extension Results - Tocilizumab in Scleroderma
November 13 2016 10:25 AM ET — via RheumReports
Longer-term (open-label) data were presented by Khanna D, et al (#969) from the subcutaneous tocilizumab (TCZ) trial vs. placebo in active diffuse scleroderma*.
The patients in this follow-up of the RCT who were crossed over from placebo to TCZ had outcomes that were similar to the patients who received active treatment during the first phase of the trial. There was actually more skin improvement in the second year for the patients who were on TCZ and stayed on active treatment in the open-label year of the trial.
The incidence of serious infections was higher in this SSc trial than it was in RA trials for both active treatment with TCZ and placebo, which allows for comparisons between diseases since we know the background rate of infection in the placebo/control groups.
The effect on skin improvement over 2 years was just 9 points less compared to a 3-point reduction at the end of year 1, meaning that TCZ takes time to soften the skin (which could be the nature of skin turnover with fibrosis).
Future trials should plan for a second year of open-label extension so we can learn what happens with longer treatment – again from what we know in RA, often the ACR responses level out before year 1.
I think we have more potential treatments for active diffuse scleroderma.
*JP has a disclosure: I participated in the TCZ SSc trial.
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About the Author
Dr. Janet Pope
Dr. Janet Pope is Professor of Medicine at Western University and Division Head of Rheumatology. Dr. Pope's research interests include epidemiologic studies in scleroderma, classification criteria in systemic sclerosis, systemic lupus erythematosus and rheumatoid arthritis.
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