Autoinflammatory & rare systemic diseases
A double-blind, placebo-controlled, randomized withdrawal trial of sarilumab for the treatment of glucocorticoid-dependent sarcoidosis
Authors' conclusion
In this double-blind, placebo-controlled, randomized withdrawal trial, a meaningful signal of improvement in subjects with sarcoidosis treated with sarilumab was not observed.
Study context
- Population
- Subjects with biopsy-proven glucocorticoid-dependent sarcoidosis, Stanford University, November 2019 to September 202210 completed period 1
- Participants
- 15 subjects
- Comparison
- Continued sarilumab vs matching placebo for 12 weeks after open-label sarilumab run-in
- Sarilumabn = 2
- Placebon = 8reference
- Primary endpoint
- Flare-free survival
Methodological detailsphase II, double-blind, placebo-controlled, randomized withdrawal, single-centre
- Phase II
- Double-blind
- Placebo-controlled
- Randomized withdrawal
- Single-centre
Primary result
As reported in the abstract
Sarcoidosis flare during period 2 · 12 weeks
Sarilumab
0
events
Placebo
12.5%
1 of 8
Further findings
Discontinuation due to worsening sarcoidosis during open-label period 1 · period 1 (16 weeks)
- Discontinued due to worsening of sarcoidosis, 4 of 15 subjects
- 26.7%
- Open-label sarilumab period, all enrolled subjects
CT chest imaging worsened during open-label period 1 · period 1 (16 weeks)
- CT chest imaging worsened, 5 of 15 subjects
- 35.7%
- Open-label sarilumab period, all enrolled subjects
Safety
Tolerability
- Sarilumab 200 mg generally well tolerated
Original publication
A double-blind, placebo-controlled, randomized withdrawal trial of sarilumab for the treatment of glucocorticoid-dependent sarcoidosis. Rheumatology (Oxford). Published 20 July 2023. doi:10.
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