Will the SC injection be a new treatment option for IBD?

Celltrion unveiled the research results of Remsima SC follow-up study…effective after dose escalation

The effectiveness of Tremfya SC induction therapy has been confirmed…results similar to those of the IV injection

The clinical accomplishments of subcutaneous formulation (SC) new drugs are being noticed in the inflammatory bowel diseases (IBD) area, including Crohn's disease and ulcerative colitis.

 

Celltrion's Remsima SC clinical results have recently shown improved endoscopic and histologic remission rates.

 

Janssen's Tremfya SC induction therapy also showed results similar to the intravenous (IV) formulation.

 

Remsima SC showed clinical recapture after dose escalation According to industry sources on February 27, Celltrion unveiled its clinical results during the European Crohn´s and Colitis Organisation (ECCO) annual conference held for four days in Berlin, Germany.

 

Remsima SC is Celltrion's in-house developed biologic medicine, changing the existing IV injection to SC formulation.

 

Remsima is a biosimilar version of Janssen's inflammatory bowel disease medication Remicade.

 

In November 2019, Celltrion obtained approval for Remicade's SC injection formulation, Remsima, in Europe and began challenging the market.

 

IBD is characterized by repetitive improvement and recurring chronic inflammation in the gastrointestinal tract caused by an abnormal immune response.

 

Ulcerative colitis and Crohn's disease are types of IBD.

 

Repetitive gastrointestinal tract symptoms, including diarrhea, blood in stool, and abdominal pain, significantly affect daily life but treatments are lacking.

 

Therefore, patients need new treatments.

 

Celltrion

The recently presented phase 3 clinical trial is a study result of Remsima SC involving patients with moderate to severe ulcerative colitis (UC) and Crohn's disease (CD).

 

The analysis was based on two years of post hoc data analysis of the LIBERTY-CD and LIBERTY-UC clinical trials, which were the basis of approval.

 

The effects were analyzed in patients who had a loss of response during the previous treatment with Remsima SC 120 mg, and then the dose was escalated to 240 mg.

 

The analysis results indicate that 66.0% (31/47 patients) of the CD patients and 69.4% (43/62 patients) of UC patients showed clinical recapture after dose escalation following loss of response.

 

Ultimately, 85.1% (40/47 patients) of CD patients and 82.3% (51/62 patients) of UC patients had clinical recapture at 102 weeks.

 

Notably, in CD patients, the early clinical recapture group had increased serum drug levels from 8.0 to 22.1 μg/mL following dose escalation, and the later clinical recapture group had increased serum levels from 11.1 to 19.8μg/mL.

 

In UC patients, both the early clinical recapture group and later clinical response group (7.4 to 16.5 μg/mL) had increased serum drug levels.

 

A researcher said, "The current study result confirmed that dose escalation of Remsima SC induces rapid clinical recapture in patients who experienced loss of response.

 

Through further studies, we need to analyze factors related to the clinical recapture rate in depth.

 

Janssen's Tremfya SC induction therapy demonstrated effectiveness Janssen unveiled its clinical results for the SC formulation of Tremfya SC at ECCO 2025.

 

Tremfya is an autoimmune disease therapy that blocks or inhibits the interleukin (IL)-23 signaling pathway.

 

By suppressing IL-23, a key mediator of inflammation, the treatment has shown to be effective in several chronic immune-mediated conditions, including CD, UC, psoriasis, and palmoplantar pustulosis.

 

Janssen

The efficacy of Tremfya was previously demonstrated in the QUASAR study using an IV induction therapy followed by SC maintenance therapy.

 

In the recent Phase 3 ASTRO trial, the effectiveness and safety of SC induction therapy were evaluated in patients with moderate-to-severe UC.

 

Treatment for IBD is divided into induction therapy and maintenance therapy.

 

Induction therapy aims to induce remission in patients with severe active disease.

 

Maintenance therapy is used to sustain remission.

 

The ASTRO study was a multinational, randomized, double-blind, placebo-controlled trial that enrolled 418 UC patients who were either unresponsive or intolerant to corticosteroids, immunosuppressants, biological agents, or Janus kinase (JAK) inhibitors or who had not previously received these treatments.

 

The primary endpoint was clinical remission at week 12, based on clinical indices and endoscopic scores.

 

The clinical results revealed that the Tremfya SC group achieved a clinical remission rate of 27.6%, compared with 6.5% in the placebo group.

 

Additionally, the endoscopic and histo-endoscopic mucosal improvement rates were 37.3% and 30.5% in the Tremfya SC group, which were substantially higher than the 12.9% and 10.8% observed in the placebo group.

 

Safety profiles were comparable between the Tremfya SC and placebo groups, with similar incidences of adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation.

 

A researcher commented, "The ASTRO study provides important data that extends the previous Tremfya IV induction regimen results.

 

This demonstrates that Tremfya is highly effective not only in its IV formulation but also in SC induction therapy, and it can be used in patients with moderate-to-severe UC without raising new safety concerns." Based on these clinical results, Janssen submitted a biologics license application (BLA) for Tremfya SC induction therapy to the U.S.

 

Food and Drug Administration (FDA) in November last year.