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P325 Integrating efficacy and safety of vedolizumab and other advanced therapies for the treatment of ulcerative colitis: Results from a network meta-analysis

V. Jairath*1, K. Lasch2, K. Chan3, S. Kanters4, J. Jansen4, C. Agboton5, H. Patel6

1Western University, London, ON, Canada, 2Takeda Pharmaceuticals International, Deerfield, IL, USA, 3Precision Xtract, Vancouver, BC, Canada, 4Precision Xtract, Oakland, CA, USA, 5Takeda Pharmaceuticals International AG, Zurich, Switzerland, 6Takeda Pharmaceuticals International, Deerfield, USA

Background

Direct head-to-head comparisons of the efficacy and safety of advanced therapies for ulcerative colitis (UC) are limited. We performed a systematic literature review and indirect treatment comparison of randomised controlled trials (RCTs) of biologics and tofacitinib (TOFA) for UC.

Methods

Medline, Embase, and Cochrane Library databases were searched from 1997 to July 2018 to identify RCTs of vedolizumab (VDZ), adalimumab (ADA), infliximab (IFX), golimumab (GOL) and TOFA. Efficacy outcomes were sustained response and remission at 1 y. Safety outcomes were overall adverse events (AEs), serious AEs (SAEs), overall infections, serious infections, and AEs leading to discontinuation as reported at 1 year. Odds ratios (OR) with 95% credible intervals (CrI) were estimated using network meta-analyses (NMA) and were transformed into number-needed-to-treat (NNT) and number-needed-to-harm (NNH) using the pooled placebo (PBO) estimates across all trials. Results are reported for the overall population and among bio-naïve patients. Data for sustained response and remission with TOFA for bio-naïve patients were not available.

Results

Six RCTs were included in the NMA. Overall, VDZ 300 mg Q8W had statistically significantly higher chances of sustained response and remission (OR: 2.20 [1.07–4.64] and 2.57 [1.09–6.13], respectively) compared with ADA. In bio-naïve patients, VDZ 300 mg q8w had numerically higher OR of both sustained response and remission compared with all other therapies; however, the results were not statistically significant (data not shown). Compared with PBO, the OR of SR was statistically significantly higher for all the interventions (Table 1). The lowest NNT for sustained remission was with TOFA in the overall population and with VDZ in bio-naïve patients. Similar trends were observed for SR. The risk of all the AEs (including SAEs) was numerically the lowest with VDZ, with NNH values closest to PBO (Table 2).

Conclusion

Indirect treatment comparisons from this NMA suggested VDZ may achieve higher rates of both sustained response and sustained remission than comparator therapies in the overall study populations and was associated with lowest risk of AEs. These findings support the favourable benefit-risk profile of VDZ in UC, especially in bio-naïve patients. Head-head trials are required to confirm the findings.

Table 1. Odds ratios and number-needed-to-treat for sustained remission with vedolizumab and other treatments for ulcerative colitis.

Table 2. Odds ratios and number-needed-to-harm for safety outcomes with vedolizumab and other treatments for ulcerative colitis.