S748 Early PRO-2 Symptom Remission Following Guselkumab Induction Treatment: Results Through Week 12 of the Phase 2 GALAXI 1 Study

Introduction: GALAXI 1 is a ph 2, double-blind, PBO-controlled study of guselkumab (GUS), an IL-23 antagonist, for the treatment of pts with moderately to severely active CD who had inadequate response or intolerance to conventional therapies (corticosteroid, immunosuppressant) and/or biologics (TNF antagonist, vedolizumab). PRO-2 symptom remission is a measurement of efficacy based on mean daily patient reported symptoms of abdominal pain (none, mild, moderate and severe) and the number of liquid or very soft stools (stool frequency). Here we report change from baseline in abdominal pain (AP), stool frequency (SF) and PRO-2 remission following induction with GUS vs PBO in an interim analysis cohort. Methods: Pts with moderate to severe CD (CDAI score 220-450) were randomized 1:1:1:1:1 to GUS 200, 600, or 1200mg IV at Wks 0, 4, 8; ustekinumab (UST) ∼6mg/kg IV at Wk 0 and 90mg SC at Wk 8; or PBO IV. AP, SF, and PRO-2 symptom remission (AP mean daily score at or below 1 and mean daily SF score at or below 3 and no worsening of AP or SF from baseline) were evaluated from Wk4 through Wk12 for pooled GUS arms vs PBO. UST was a reference arm. Results: Two hundred fifty pts were evaluated with ∼50% having failed previous biologic therapy (mean CD duration, 8.8yr; mean CDAI, 306.2; median CRP, 5.4mg/L; median FeCal, 594.0mg/kg). Mean baseline AP for PBO and GUS combined was 2.04 and 2.02, respectively; mean baseline SF for PBO and GUS combined was 5.51 and 5.27, respectively. Other baseline demographics and disease characteristics were generally similar among treatment groups. Pts treated with GUS had greater reductions in AP and SF through Wk12 compared with PBO (Fig 1). At Wks 4, 8, and 12, higher proportions of GUS-treated pts achieved PRO-2 remission compared with PBO (Table 1). Similarly, within each subgroup of pts who failed biologic therapy (BIO-failure) or conventional therapy (CON-failure), GUS-treated pts achieved a higher rate of PRO-2 remission at Wks 4, 8, and 12 compared with PBO. Conclusion: In moderately to severely active CD, pts treated with GUS had greater reductions in AP and SF at all post-baseline visits. Furthermore, a higher proportion of pts achieved PRO-2 remission during induction dosing compared with PBO. For the overall population, as well as for BIO- and CON-failure subgroups, the differences between GUS and PBO-treated pts increased over time with a greater proportion of GUS-treated pts achieving early PRO-2 remission. Small sample sizes limit conclusions for subgroups.Figure 1.: Relationship between Anxiety, Depression and Fatigue PROMIS raw score and Perceived vulnerability to illness.Table 1.: Descriptive Characteristics of Subject Demographics.

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