Table 5: Efficacy data from SYLVANT® pivotal trial in iMCD patients; analyses are for the intention-to-treat population, unless specified6, 8
BSC, best supportive care; Hb, haemoglobin
N/A not applicable, there were no responders in the placebo arm, therefore duration is not applicable.
NE not evaluable
a A ≥50% reduction in overall MCD-related Overall Symptom Score sustained for at least 18 weeks prior to treatment failure.
b Complete symptomatic response is defined as 100% reduction in baseline MCD overall symptom score sustained for a least 18 weeks prior to treatment failure
c Hb response-evaluable population
d Data from 11 of 13 complete symptomatic responders were censored due to on-going response
e At the time of primary analysis, data for 19 of 20 tumour and symptomatic responders were censored due to on-going response
6. Janssen-Cilag Ltd. SYLVANT 100 mg powder for concentrate for solution for infusion. Summary of Product Characteristics 2019 [Available from: https://www.medicines.org.uk/emc/product/2132/smpc.
7. Janssen Research & Development LLC. A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman’s Disease 2018 [Available from: https://clinicaltrials.gov/ct2/show/NCT01024036?term=siltuximab&recrs=e&phase=1&draw=2&rank=3.
8 Van Rhee F, Wong RS, Munshi N, Rossi JF, Ke XY, Fossa A, et al. Siltuximab for multicentric Castleman’s disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014;15(9):966-74.