Policy & Regulation
Janssen Pharmaceutical to withdraw phase three LOTUS study of STELARA
29 June 2020 -

The Janssen Pharmaceutical Companies of Johnson & Johnson has decided to withdraw the phase three LOTUS study of STELARA (ustekinumab) in Systemic Lupus Erythematosus (SLE), it was reported on Friday.

The company has taken this step because of the lack of efficacy in SLE.

Interim safety findings for Stelara were consistent with the product's known safety profile and no new safety signals were found.

Investigators, study participants and health authorities have been informed of the decision. The company intends to thoroughly analyse the totality of the study data and publish findings. The company stated that the decision to discontinue the LOTUS study does not impact any other ongoing studies with ustekinumab or current indications.



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