New Phase 2b Data Show the Majority of Adults with Moderately to Severely Active Ulcerative Colitis Achieved Clinical Response with TREMFYA® (guselkumab) at 12 Weeks

News on February 19, 2022 /BioValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced the results of the Phase 2b QUASAR induction study of Tremfya (Trevo, generic name: guselkumab) for the treatment of ulcerative colitis (UC) at the 17th Congress of the European Crohn's and Colitis Organisation (ECCO) in 2022. The primary endpoint data showed that, in adult patients with moderate to severe active UC who had an inadequate response or were intolerant to conventional therapies and/or selected advanced therapies, treatment at week 12...Compared with the placebo group, a significantly higher proportion of patients in the Tremfya treatment groups achieved clinical response (Intravenous [IV] Tremfya 200mg: 61.4% [n=62/101]; IV Tremfya 400mg: 60.7% [n=65/107]; Placebo group: 27.6% [n=29/105]).

In the study, the primary endpoint clinical response was defined as a ≥30% and ≥2-point reduction in the modified Mayo score from induction baseline, and a ≥1-point reduction in the rectal bleeding subscore from baseline or a rectal bleeding subscore of 0 or 1. The key secondary endpoints included clinical remission at week 12 of treatment, symptom relief, endoscopic improvement, histologic-endoscopic mucosal improvement, and endoscopic normalization.

Results of the five secondary endpoints showed that: (1) 25.7% and 25.2% of patients in the Tremfya 200mg group and 400mg group, respectively, achieved clinical remission, compared to 9.5% in the placebo group. (2) 50.5% and 47.7% of patients in the Tremfya 200mg group and 400mg group, respectively, achieved symptomatic relief, compared to 20.0% in the placebo group. (3) 30.7% and 30.8% of patients in the Tremfya 200mg group and 400mg group, respectively, achieved endoscopic improvement, compared to 12.4% in the placebo group. (4) 19.8% and 27.1% of patients in the Tremfya 200mg group and 400mg group, respectively, achieved histologic-endoscopic mucosal improvement, compared to 8.6% in the placebo group. (5) 17.8% and 14% of patients in the Tremfya 200mg group and 400mg group, respectively, achieved endoscopic normalization, compared to 6.7% in the placebo group.

In the study, the safety results of the two Tremfya dosage groups were consistent with the safety profile in the approved indications. Compared with the placebo group, the proportion of patients reporting adverse events (AEs), serious adverse events, and adverse events leading to discontinuation was not higher in the two Tremfya dosage groups. No infections or malignancies were reported.TumorOr death case report.

Tremfya has not yet been approved for the treatment of adult patients with UC. Results from the Phase 2b QUASAR induction study provide initial evidence supporting the development of Tremfya as a potential therapy for adult patients with moderately to severely active UC. Currently, the Phase 3 QUASAR induction and maintenance study evaluating Tremfya for the treatment of adult patients with moderate to severe active UC is ongoing.

Tremfya is the first regulatory-approved selective IL-23 inhibitor. The drug is a monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a cytokine involved in variousAutoimmunePlayed a key role in sexually transmitted diseases.

To date, Tremfya has been approved in many countries and regions worldwide for the treatment of adult patients with moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA).

In China, Tremfya (Tenojaw) was approved for marketing in Hong Kong in November 2018, submitted for marketing in mainland China in late June 2019, and received approval from the National Medical Products Administration (NMPA) in December 2019 for the treatment of adult patients with moderate to severe plaque psoriasis suitable for systemic therapy.

It is worth mentioning that Tremfya was included in the "First List of Overseas New Drugs in Urgent Clinical Need" released by the Center for Drug Evaluation (CDE) under the NMPA, with treatment indications for: erythrodermic psoriasis, plaque psoriasis, pustular psoriasis, psoriatic arthritis, and vulgar psoriasis. The NMPA expedited the approval of Tremfya's market entry following the priority review and approval process. (Bioon.com)

Source of Original Text:New Phase 2b Data Show the Majority of Adults with Moderately to Severely Active Ulcerative Colitis Achieved Clinical Response with TREMFYA® (guselkumab) at 12 Weeks