Past Coverage of EULAR 2015Past Coverage of EULAR 2015 Return To RheumReports Home
Are we close to having a biologic in systemic sclerosis (scleroderma)?
June 11 2015 9:26 AM ET — via RheumReports
Early diffuse scleroderma has a high morbidity and mortality. The usual treatment may include methotrexate which has borderline effects on improving the skin score and possibly restrictive lung disease. Others have considered cyclophosphamide for lung disease and aggressive skin involvement in early diffuse subset. There is also one small trial of rituximab that over two years seemed to improve both skin and lung disease with repeat treatment. Stem cell transplation is reserved (if even available for the wort subset of rapidly progressive early diffuse scleroderma due to the high mortality early with treatment and costs and morbidity but is life prolonging by 3 years compared to cyclophoshamide). So other treatment is needed. A trial is underway studying abatacept in early diffuse scleroderma.
Dr. Dinesh Khanna presented at EULAR (OP0054) the results of a Phase II trial of tociluzimab vs. placebo over 6 months in early diffuse scleroderma where at 6 months if criteria of worsening occurred, a background immune suppressive could be added and the double blind trial continued for one year in 87 patients. The skin score (modified Rodnan skin score) improved more with tociluzimab 162 mg sc weekly compared to placebo with a borderline p-value (.06). The between groups difference in skin score was modest (3.6 units). Patient reported outcomes favored active drug but were not significant (secondary endpoints). The change in lung function as measured by forced vital capacity (FVC) worsened less in the tociluzimab group. I will openly declare my conflicts (I was first author on the old methotrexate trial where we reported a negative study due to a p value of .06 and I was an author on the tocilizumab trial.
So, is this the answer? I think that this is important data but not with the magnitude of efficacy we think of with cytokine inhibition in RA. This drug will go in to Phase III clinical trials but perhaps a combination study design with a DMARD such as methotrexate or azathioprine would give more bang for the large buck. However, the clinical trial in the next phase is mirroring the phase II trial. We are getting closer to having positive trials in SSc where there are not many options for our patients.
Share This Report
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.
View Full Bio