Anirudh P. Bhandare, MD1, Benjamin J. Crooks, MA, MBBS, MRCP2, J Taylor, BSC2, Jimmy K. Limdi, FRCP, FACG2
1Northern Care Alliance, Manchester, England, United Kingdom; 2Northern Care Alliance, Bury, England, United Kingdom
Introduction: Ustekinumab(UST),an IgG1 monoclonal antibody targeting IL12/IL23(p40 sub-unit)has been licensed in UK for use in moderate to severe Crohn’s disease(CD) since 2017.We present a real -world experience from our center.
Methods: A retrospective analysis of patients commenced on UST was conducted using electronic medical records to evaluate efficacy. Patients were assessed at baseline,induction(week 8) and at 1 year. Our primary end point was reduction in Physicians global assessment (PGA) .Secondary endpoints were improvement in CRP( >10 at baseline),Fecal Calprotectin( >250 at baseline) and albumin(< 35 at baseline).Concomitant medication and surgical history were also recorded.
Results: 62 patients received UST(42 female; mean age 44.74).Mean age at diagnosis was 33.61years and average duration of disease was 135 months (median 180,IQR 135.25). Sixteen patients had previous surgery for CD. At baseline 95% patients had PGA of moderate to severe disease with 54 (87%) achieving primary endpoint at induction.16 patients had annual follow up and 81.25% achieved the primary endpoint.The Harvey Bradshaw index at follow up appointments correlated with the PGA values to account for clinical remission. From baseline to induction, 24 had CRP >10. Of these, 20 (83.3%) patients achieved the secondary endpoint for CRP at induction.At annual follow up 15 patients had CRP recorded, 7 out of them had CRP >10 at baseline and all achieved the secondary endpoint. Albumin was < 35 in 21 patients at baseline and 71.5% showed improvement at induction.At 12 months eight of the above 21 had albumin recorded and 5 achieved the secondary endpoint of improvement in albumin. Fecal calprotectin was elevated in 19 out 47 patients recorded at baseline.Of whom 58% achieved the secondary endpoint. 53 patients (85.5%)had received a previous biologic with 20 receiving Infliximab (IFX),adalimumab (ADA) and vedolizumab (VDZ) prior to UST.15 received only IFX,11 only ADA and 20 both anti-TNF’s .One patient received IFX and VDZ. Four adverse reactions were noted, 2 had rash after infusion and 1 headache.One patient reported epidydimo-orchitis 7 days post infusion and required hospitalisation.Twelve patients discontinued UST with 6 having surgery and 6 from loss of response(5 secondary and 1 primary loss of response)
Discussion: UST is effective in induction well as maintenance of remission in CD for biologic experienced and naive patients as also in those with previous surgical resection.There were no significant safety concerns.
Citation: Anirudh P. Bhandare, MD; Benjamin J. Crooks, MA, MBBS, MRCP; J Taylor, BSC; Jimmy K. Limdi, FRCP, FACG. P2332 - REAL WORLD EXPERIENCE OF USTEKINUMAB FOR INDUCTION AND MAINTENANCE OF REMISSION IN CROHN’S DISEASE: A U.K. SINGLE CENTER EXPERIENCE. Program No. P2332. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.