S1454 Efficacy and Safety of Subcutaneous Guselkumab Rescue Therapy in Patients With Moderately to Severely Active Crohn’s Disease and Inadequate Response to Ustekinumab: Results From GALAXI 1, 2, & 3 Long-Term Extension

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Introduction: The phase 2b GALAXI 1 and phase 3 GALAXI 2 & 3 studies evaluated guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor, in pts with moderately to severely active Crohn’s disease (CD). Pts treated with ustekinumab (UST) who met inadequate response criteria during the long-term extension (LTE) could switch to GUS 200 mg subcutaneously (SC) every 4 weeks (Wks). We present efficacy/safety results in pts who received GUS after experiencing an inadequate response to UST in the pooled GALAXI LTE. Methods: Individuals with prior inadequate response/intolerance to UST were excluded from GALAXI; however, during the LTE, pts treated with UST 90 mg SC every 8 weeks who met inadequate treatment response criteria(not in clinical response and CDAI ≥220) between Wks 52-80 were eligible for treatment switch to GUS 200 mg SC every 4 weeks, without intravenous (IV) induction. Clinical response and clinical remission were both assessed 16 wks after treatment switch. Endoscopic response and endoscopic remission were assessed at Wk 96. Safety was assessed through Wk 96. Results: In total, 80 pts treated with UST underwent treatment switch to GUS 200 mg SC every 4 weeks; 75 pts were included in the efficacy analyses(baseline mean age, 35.2 yrs; male, 64.0%; mean CD disease duration, 8.21 yrs; mean CDAI, 291.5; mean SES-CD, 12.8; history of inadequate response/intolerance to biologics [BIO-IR], 60.0%). Proportions of pts achieving clinical response and clinical remission 16 wks after treatment switch from UST to GUS 200 mg SC every 4 weeks were comparable to proportions of pts treated with GUS 200 mg IV every 4 weeks induction in the pooled GALAXI 2 & 3 BIO-IR subgroup who achieved clinical response and clinical remission at Wk12. Proportions of pts achieving endoscopic response and endoscopic remission at Wk 96 (ie, ∼1 yr after treatment switch) were similar to proportions of pts in the pooled GALAXI 2 & 3 BIO-IR subgroup receiving GUS 200 mg SC every 4 weeks maintenance who achieved endoscopic response and endoscopic remission at Wk 48. Conclusion: Among pts who experienced inadequate response to UST in the LTE, more than half achieved clinical remission 16 wks after treatment switch to GUS 200 mg SC every 4 weeks, and ∼50% were in endoscopic response ∼1 yr after treatment switch. These data suggest pts with an inadequate treatment response to UST may benefit from GUS treatment. Results should be interpreted considering that pts received GUS SC maintenance therapy directly without IV induction. Key safety event rates were consistent with the known safety profile of GUS in approved indications.

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