The clinical response rate is 79%! Positive mid-term clinical data of Johnson and Johnson's stelara Crohn's disease 3B

Compiling coco Recently, Johnson & Johnson's Janssen Pharmaceutical released the mid-term analysis data of Stardust, the 3B phase clinical open label study of stellara (ustekinumab), an anti-inflammatory drug Stardust is a randomized, international, multicenter, interventional phase 3B study in which 500 patients with moderate to severe active Crohn's disease (CD), who had not received or received more than one biological drug treatment before, received stellara (~ 6mg / kg) intravenously and injected 90 mg stellara once subcutaneously in the eighth week At week 16, patients with a decrease in the CDAI score of ≥ 70 (reaching the cdai70) were randomly assigned to the target treatment group or the standard nursing treatment group (1:1) and followed up until the end of the study (week 48) Target to target therapy is an active treatment strategy, and the results of its monitoring (such as endoscopic response, biomarkers and clinical symptoms) are often used to guide the use of drugs The results showed that in the 16th week, 79% of the patients achieved clinical response, and 67% of the patients were in clinical remission Moreover, intestinal ultrasound (IUS) can be detected as early as the 4th week In addition, the primary end point of the study was to assess the proportion of patients with endoscopic response, defined as a reduction of ses-cd by ≥ 50% from baseline within 48 weeks Endoscopy at week 16 was measured only in the target treatment group The results showed that 37% of the 220 cdai70 responders randomly assigned to the target treatment group achieved endoscopic response at week 16 IUS is a complementary method to evaluate CD activity based on the measurement of transmural intestinal characteristics, such as intestinal wall thickness and excessive angiogenesis "Patients with Crohn's disease may respond to treatment, but at the same time continue to develop internal inflammation, which may cause irreversible damage, so patients need more active and stable treatment methods and less invasive monitoring methods." "These data demonstrate the potential clinical utility of noninvasive IUS in helping to guide CD therapy," said Professor Silvio danesei, head of the inflammatory bowel disease center at the humanitas research hospital in Milan, Italy Stardust is the first study to use endoscopic response to guide the treatment strategy of CD target, and also the first study to use IUS intervention to monitor the treatment of CD patients The next step in the Stardust study is to determine whether early IUS responses at week 4 predict long-term clinical (week 16 through week 48) and endoscopic outcomes in CD patients Dr Jan wehkamp, vice president of Janssen Pharmaceutical and head of Gastroenterology, said, "Stardust is an important milestone in our commitment to helping CD patients and doctors The current data may provide important clinical help and reference for future treatment strategies "