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Johnson & Johnson Reports High Long-Term Crohn's Remission Rates for Tremfya in Phase 3 Trials

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JNJ$263.73 0.88%

Johnson & Johnson (JNJ) announced long-term Phase 3 clinical data for Tremfya (guselkumab) showing high remission rates in adult patients with Crohn's disease over a three-year period. In the GALAXI 2 and GALAXI 3 studies, participants receiving 100 mg every eight weeks achieved a 94% clinical remission rate, while those receiving 200 mg every four weeks reached a 91% remission rate.

The findings highlight durable efficacy for the treatment across multiple clinical measures. Along with high overall remission, 88% of patients across both dosing schedules achieved 90-day corticosteroid-free clinical remission. Additionally, endoscopic remission was reached by 52% of participants on the eight-week regimen and 61% of those on the four-week schedule. In a separate Phase 3 trial named FUZION, Tremfya also demonstrated significantly higher combined fistula remission rates at 24 weeks compared to a placebo.

Investors and healthcare market participants will monitor ongoing clinical developments, regulatory updates, and potential commercial performance of Tremfya as additional subgroup evaluations and long-term data emerge.

Key points

  • Long-term Phase 3 trials GALAXI 2 and GALAXI 3 showed Tremfya delivered up to 94% clinical remission in Crohn's disease patients over three years.
  • In the GALAXI trials, 52% of patients on an eight-week dosage and 61% on a four-week dosage reached endoscopic remission.
  • Both dosage groups in the GALAXI study achieved an 88% rate of 90-day corticosteroid-free clinical remission.
  • Phase 3 FUZION study results demonstrated higher combined fistula remission rates at week 24 for Tremfya compared to placebo.

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Questions and answers

What were the three-year clinical remission rates for Tremfya in Crohn's disease patients?

Patients receiving 100 mg of Tremfya every eight weeks achieved a 94% clinical remission rate, while those treated every four weeks saw a 91% clinical remission rate over three years.

How did Tremfya perform in corticosteroid-free remission?

In the GALAXI 2 and GALAXI 3 Phase 3 trials, 88% of patients in both dosing groups achieved 90-day corticosteroid-free clinical remission.

What were the findings from the Phase 3 FUZION study?

Tremfya achieved combined fistula remission at week 24 in 28% of patients on the eight-week regimen and 27% on the four-week regimen, compared to 10% for placebo.