Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis : a Prospective, Randomized, Controlled Trial
In severe refractory sarcoidosis not responding to conventional immunosuppressive treatment, the third-line tumor necrosis factor (TNF)-alpha inhibitor infliximab is an alternative. Treatment duration is not known, although it has been suggested that relapse rates after withdrawal could be high. We hypothesize that a prolonged course of TNF-alpha would be better for maintaining remission in sarcoidosis. The population consists of histologically-proven adults sarcoidosis patients who were treated with infliximab and are in remission for at least 6 months with less than or equal to 10 milligrams of steroids (prednisone). The present study is a phase 3, prospective, randomized, parallel groups, comparative, open-labelled 2 arms study superiority trial comparing a STOP to a REMAIN strategy. Patients will be randomized in the 2 groups in a 1:1 ratio.
• Age superior or equal to 18 years
• Clinical and radiological presentation consistent with sarcoidosis
• Presence of non-caseating granulomas in at least one organ
• Exclusion or other causes of granulomas
• Infliximab treatment for at least 6 months
• Steroid dosage \< or equal to 10 mg/day for at least 6 months
• No activity of the disease (ePOST score 0) for at least 6 months
• Normal ACE (angiotensin converting enzyme) and serum calcemia level
• Signed informed consent
• Affiliated to the National French social security system
• As infliximab is the most used TNF-alpha antagonists, we decided to include only patients treated with infliximab to increase the homogeneity.