Cure8 news brief
Long-term (3-year) data on a biologic for Crohn's disease may indicate how durable treatment benefits and steroid-free remission can be for people considering or already on biologic therapy.
Adult patients with moderately to severely active Crohn's disease, people on or considering biologic therapy, gastroenterologists/IBD clinicians, and researchers tracking long-term biologic outcomes.
Johnson & Johnson reported Week 144 (3-year) long-term extension results from the Phase 3 GALAXI 2 and 3 programs. Patients received IV induction followed by subcutaneous maintenance with either 100 mg every eight weeks or 200 mg every four weeks.
The company reports as-observed clinical remission rates up to 94% and endoscopic remission up to 61% at Week 144, and 88% achieved 90-day corticosteroid-free clinical remission in both regimens.
The results presented are from long-term extensions (as-observed analyses) that include participants who remained on treatment and had Week 144 data; participants with dose adjustments were excluded. The announcement states safety through Week 144 was consistent with TREMFYA's established Crohn's disease safety profile.
Keep following your care team about what these results might mean for treatment options; regulatory status, full peer-reviewed publication details, and independent expert review provide important next steps for interpreting company-reported trial extensions.
These figures come from as-observed long-term extension data reported by the company and presented at a conference; as-observed analyses include only people who remained on treatment and had Week 144 data, which can give higher remission percentages than intent-to-treat analyses.
Full peer-reviewed publications and regulatory updates will provide more complete context about methods, safety, and applicability.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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