Poor efficacy! Johnson and Johnson terminated Stelara's treatment of systemic lupus global Phase III clinical.

Guide: Stelara showed no significant efficacy compared to placeboJohnson and Johnson's Janssen Pharmaceuticals recently announced its decision to discontinue the evaluation of the anti-inflammatory drug Stelara (ustekinumab, ustenu sepsis) to treat systemic lupus (SLE) Phase III LOTUS study (NCT03517722) due to poor efficacyLOTUS is a global, randomized, double-blind, placebo-controlled, parallel group III study conducted in patients with active SLEThe study included 516 patients, including patient representatives from a small group severely affected by lupusThe primary endpoint was the proportion of patients who achieved the SRI-4 (SLE respondent index 4) response in week 52 of treatmentSRI-4 is a comprehensive evaluation tool that combines three different, validated lupus disease index scores to define respondents and non-respondentsa pre-planned mid-term efficacy analysis showed that Stelara did not show significant efficacy compared to placebosThe interim security results are consistent with the known safety characteristics of Stelara and no new safety signals have been foundbased on the interim analysis, Johnson and Johnson made the decision to terminate the LOTUS studyIt is worth noting that as a result of this decision, the second phase III study LOTUS-C (NCT040608888), originally scheduled to be conducted in China in June this year, will not be launched, and the study was originally scheduled to include 190 active SLE patientstheLOTUS project was initiated, based on data from STELARASLE, a successful 2017 global placebo-controlled phase II study: At a 24-week double-blindness period, the Stelara treatment group achieved a significantly higher proportion of patients with SRI-4 responses (62% vs 33%, p-0.0057) in the 24-week double-blindness period, reaching the primary endpoint of the studyIn addition, 63% of patients who switched from placebo to Stelara for one year at week 24 achieved a SRI-4 responsenote that the decision to terminate the LOTUS project will not affect other ongoing research in Stelara or currently approved indicationsStelara is a monoclonal antibody that targets leukocyte interleukin 12 (IL-12) and leukocyte interleukin 23 (IL-23) to inhibit these two pre-inflammatory cytokines by binding to the p40 subunits common to IL-12 and IL-23 to prevent them from binding to cell surface receptorsIL-12 and IL-23 are two naturally occurring proteins that are thought to play a key role in immune-mediated inflammatory diseasesStelara, which was listed in 2009, has been approved for a number of therapeutic indications, including: (1) moderate to severe plaque psoriasis adolescents (s12 years) and adult patients (18 years) ;( 2) adult patients with active psycosphrasis arthritis (PsA); in China, Stelara was approved for sale in November 2017 for the treatment of moderate to severe plaque-type psoriasis In March, the drug was approved for a second indication sisyd in adult patients with moderate to severe CD , Stelara generated sales of $6.361 billion in 2019 In January, Evaluate Vantage, a pharmaceutical market research firm, published an article in Nature Review Drug Discovery predicting that Stelara's global sales this year would reach $7.241 billion, ranking 7th in the World's Best-Selling TOP10 drug by 2020 Reference source: Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus .