Phase 2 Study Shows High Rates of Clinical and Corticosteroid-Free Remission with TREMFYA (guselkumab) in Adults with Moderately to Severely Active Crohn’s Disease

Crohn's Disease - CD

News on February 20, 2022 /BioValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced the results of the Phase 2 GALAXI 1 study of Tremfya (Tremfya, generic name: guselkumab) for the treatment of Crohn's disease (CD) at the 17th Congress of the European Crohn's and Colitis Organisation (ECCO) in 2022.Clinical Trial(NCT03466411; EudraCT 2017-002195-13) results.

This is a double-blind, placebo-controlled, positive-controlled, dose-ranging study conducted in adult patients with moderate to severe active Crohn's disease (CD) who have had an inadequate response or intolerance to conventional therapies (corticosteroids, immunosuppressants) and/or biologics (TNF antagonists, Entyvio [vedolizumab, an α4β7 integrin antagonist]). In the study, patients were randomly and equally divided into five groups: receiving three regimens of Tremfya, Stelara (ustekinumab, an IL-12/23 inhibitor), or placebo treatment.

The results showed,At week 48 of treatment, the majority (57.4%-73%) of patients receiving Tremfya achieved clinical remission (Crohn's Disease Activity Index [CDAI] <150). Additionally, the results at week 48 also showed that the majority (57.4%-73%) of patients who achieved clinical remission with Tremfya did so without the use of corticosteroids (achieving steroid-free remission).

Results from Week 48:

——Clinical Remission: 63.9% of patients receiving Tremfya 200mg intravenous infusion (IV)/100mg subcutaneous injection (SC), 73% of patients receiving Tremfya 600mg IV/200mg SC, and 57.4% of patients receiving Tremfya 1200mg IV/200mg SC achieved clinical remission, compared to 58.7% in the Stelara treatment group.

——Clinical remission without corticosteroids: 59% of patients receiving Tremfya 200mg IV/100mg SC, 71.4% of patients receiving Tremfya 600mg IV/200mg SC, and 55.7% of patients receiving Tremfya 1200mg IV/200mg SC achieved corticosteroid-free clinical remission (CDAI<150, no corticosteroid treatment at week 48), compared to 58.7% in the Stelara positive control group.

——Patient-Reported Outcomes (PRO)-2 Relief: 57.4% of patients receiving Tremfya 200mg IV/100mg SC, 69.8% of patients receiving Tremfya 600mg IV/200mg SC, and 50.8% of patients receiving Tremfya 1200mg IV/200mg SC achieved PRO-2 remission, compared to 46% in the Stelara positive drug control group.

During the 48-week treatment period of the GALAXI 1 study, all Tremfya dose groups showed comparable safety data consistent with the known safety profile of Tremfya in its approved indications. The incidence of key safety events was similar across the three Tremfya dose groups. The incidence rates of adverse events (AE) were 71.2%, 80.8%, 69.9%, and 84.5% in the Tremfya 200 mg IV/100 mg SC, 600 mg IV/200 mg SC, 1200 mg IV/200 mg SC, and Stelara groups, respectively. The incidence rates of serious adverse events (SAE) were 8.2%, 6.8%, 6.8%, and 12.7%, respectively. No opportunistic infections, tuberculosis cases, or deaths were reported in any group. The infection rates were 34.2%, 41.1%, 34.2%, and 36.6%, respectively. The incidence rates of serious infections were 2.7%, 2.7%, 1.4%, and 1.4%, respectively.

Tremfya has not yet been approved for the treatment of CD. The 48-week data from the GALAXI 1 study, announced recently, represents an important step in the development of Tremfya. In this study, the majority of patients achieved corticosteroid-free remission, which is significant because avoiding long-term steroid use is an important consideration when treating these patients. Previously, Janssen had released the 12-week interim analysis and topline 48-week data from the GALAXI Phase 2 study. Evaluation of Tremfya for the treatment of moderate to severe active CD is in Phase 3.Clinical TrialIn progress.

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 variousAutoimmunityPlayed 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 (Tenoja) 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.

Notably, Tremfya was included in the "First List of Overseas New Drugs Urgently Needed Clinically" issued by the Center for Drug Evaluation (CDE) under the NMPA. The approved indications for treatment are: erythrodermic psoriasis, plaque psoriasis, pustular psoriasis, psoriatic arthritis, and vulgar psoriasis. The NMPA expedited the approval of Tremfya's market entry through the priority review and approval process. (Bioon.com)

Source of Original Text:The Majority of Adults with Moderately to Severely Active Crohn's Disease in a Phase 2 Study Achieved Clinical Remission and Corticosteroid-Free Remission Through 48 Weeks with TREMFYA (guselkumab)