Objective To gain an understanding of the effectiveness of golimumab in a ‘real-world’ setting.
Design Retrospective cohort study using prospectively maintained clinical records.
Setting Two UK tertiary IBD centres.
Patients Patients with ulcerative colitis (UC) were given golimumab at Guy’s & St Thomas and King’s College Hospitals between September 2014 and December 2016.
Intervention Golimumab, a subcutaneously administered antitumour necrosis factor agent.
Main outcome measures Clinical disease activity was assessed at baseline and at the first clinical review following induction therapy using the Simple Clinical Colitis Activity Index (SCCAI). Response was defined as an SCCAI reduction of 3 points or more. Remission was defined as an SCCAI of less than 3.
Results Fifty-seven patients with UC completed golimumab induction therapy. Paired preinduction and postinduction SCCAI values were available for 31 patients and fell significantly from 7 (2–19) to 3 (0–11) (p<0.001). To these 31, an additional 13 patients who did not have paired SCCAI data but stopped treatment due to documented ‘non-response’ in the opinion of their supervising clinician, were added. Among this combined cohort, 23/44 (52%) had a clinical response, 15/44 (34%) achieved remission and 13/44 (30%) achieved corticosteroid-free remission.
Faecal calprotectin and CRP fell (FC: pre-induction: 1096 (15-4800) μg/g, post-induction: 114 (11-4800) μg/g, p = 0.011; n = 20; CRP: pre-induction: 4 (1-59) mg/L, post-induction: 2 (1-34) mg/L, p = 0.01 for n = 43). Post-induction endoscopy was carried out in 23 patients and a mucosal healing (Mayo 0 or 1) rate of 35% was observed.
Conclusions Our experience mirrors previously reported real-world cohorts and demonstrates similar outcomes to those observed in randomised controlled trials. These data demonstrate a meaningful reduction in clinical, biochemical and endoscopic disease activity as well as a steroid-sparing effect in patients with previously refractory disease.
- ulcerative colitis
- inflammatory bowel disease
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Contributors MAS, PP, BHH and PMI were responsible for the original concept and planning of the study. MAS, PP, ELJ, JD-B, AD, RP, AOA and LM were responsible for data collection and analysis. MAS drafted the manuscript, which GC- F, PD, IK, NP, SHCA, JS, BHH and PMI critically reviewed and revised.
Competing interests MAS advisory fees: hospira lecture fees: hospira, takeda, MSD, Janssen, falk; ELJ : Lecture fees: takeda ; JD-Bell : Lecture fees: takeda, MSD ; NP : advisory fees: abbvie, allergan, debiopharm International,ferring, vifor pharma lecture fees: allergan, falk pharma ; PMI : advisory fees: abbvie, warner chilcott, takeda, MSD, vifor pharma, pharmacosmos, topivert, genentech, hospira,samsung bioepis lecture fees: abbvie, warner chilcott, ferring, falk pharma, takeda, MSD, Johnson and Johnson, Shire financial support for research: MSD, takeda .
Ethics approval The Health Research Authority does not consider post-marketing surveillance, research and therefore, suggests that NHS REC approval was not necessary.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement There are no unpublished data associated with the study.
Presented at BSG 2017, Manchester, UK
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