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P365 Real-world effectiveness of adalimumab in patients with ulcerative colitis

A. Armuzzi*1, C. Taxonera2, J. Panes3, P. Lakatos4, N. Fisseha5, B. Pappalardo5

1Complesso Integrato Columbus-Gemelli University Hospital Foundation, IBD Unit, Rome, Italy, 2Hospital Clínico San Carlos, IdiSSC, Madrid, Spain, 3Hospital Clínic Barcelona, Gastroenterology, Barcelona, Spain, 4Semmelweis University, First Department of Medicine, Budapest, Hungary, 5AbbVie Inc, North Chicago, Illinois, United States

Background

Adalimumab (ADA) has shown efficacy for induction and maintenance of response and remission in clinical trials of patients (pts) with moderate-to-severe ulcerative colitis (UC).1,2,3,4 Compared with controlled trials, in clinical practice, pts are more heterogeneous and physicians are able to exercise variable treatment regimens, including dose optimisation, to obtain maximal clinical benefit. We conducted a systematic literature review to evaluate the real-world (RW) effectiveness of ADA in pts with UC.

Methods

To identify published literature on the RW effectiveness of ADA in UC, public databases (BIOSIS Previews®, Derwent Drug File, Embase®, Embase® Alert, International Pharmaceutical Abstracts, MEDLINE®, PASCAL, and SciSearch®) were searched using key search terms: ADA OR Humira OR d2e7, mesh term (ulcerative colitis), and real world. Results were filtered to exclude reviews, case reports and controlled or randomised trials. In total, 30 studies in adult UC pts were identified. For this analysis, only studies that reported ‘remission’ or ‘response’ as outcomes are included.

Results

RW induction of response and remission rates (12 studies; range: 2–16 weeks [wk]) were slightly higher than or similar to those observed in ULTRA 1 and 2. However, maintenance outcomes (median 52 wk, range: 24–104 wk) were quite different. Further, 9 RW studies reported maintenance of response data at 14 time points. The median proportion of pts who achieved this outcome was 51% (range: 9–94). Further, 12/14 time points had higher response rates than those reported at wk 52 in ULTRA 2 (30%, all pts, NRI) (Figure 1A), and 11 RW studies reported maintenance of remission data at 18 time points. The median proportion of pts who achieved this outcome was 53.5% (range: 11–100). Further, 16/18 time points had higher remission rates than those reported at wk 52 in ULTRA 2 (17%, all pts, NRI) (Figure 1B).

Conclusion

In these RW studies, different definitions of response and remission were used, sample sizes varied, and physicians could adjust therapies to optimise outcomes. Given these differences, rates of induction and maintenance of response and remission with ADA treatment were often higher than those reported in randomised trials.

Table 1. A and B “Real-world effectiveness of maintenance adalimumab therapy in patients with ulcerative colitis. Proportion of patients achieving maintenance of clinical response (A), and remission (B). n, sample size at each time point”

References

1Reinisch Gut 2011 2Reinisch IBD 2013 3Sandborn Gastro 2012 4Sandborn APT 2013 5Iborra JCC 2015 6Afif IBD 2009 7Garcia-Bosch JCC 2013 8Hussey Gastro 2015 9Armuzzi DLD 2013 10Szepes JCC 2014 11Busquets JCC 2013 12Fernandez-Blanco IBD 2014 13Lequoy Gastro 2013 14Lorente JCC 2015 15Tursi Ann Gastro 2014 16Christensen Scand J Gastro 2015