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P668 Post-marketing experience of vedolizumab in inflammatory bowel disease: analysis of pneumonia and other respiratory tract infections

Bhayat F.1, Blake A.*2, Travis S.3

1Takeda Development Centre Europe Ltd, Global Pharmacovigilance, London, United Kingdom 2Takeda Development Center Europe Ltd, Global Pharmacovigilance, London, United Kingdom 3University of Oxford, Translational Gastroenterology Unit, Nuffield Department of Medicine, Oxford, United Kingdom

Background

The annual incidence of pneumonia has been reported as 13.8/1000 in patients with IBD versus 7.6/1000 in healthy subjects (IRR 1.82; 95% CI: 1.75–1.88) [1]. Vedolizumab (VDZ) is a humanised monoclonal antibody that binds to α4β7 integrin, selectively blocking gut-specific lymphocyte trafficking. Gut selectivity may reduce the infection risk compared with anti-tumour necrosis factor-alpha [anti-TNFα] agents, which cause systemic immunosuppression. Here we describe pneumonia and other respiratory tract infections reported after initiation of VDZ therapy in the post-marketing (PM) setting.

Methods

PM VDZ safety data from the Global Safety Database (May 2014–May 2016) were reviewed to identify reports of lower respiratory tract infections (LRTIs) and upper respiratory tract infections (URTIs) using the following MedDRA v19.0 High Level Terms: “LRT and lung infections”, “LRTIs not elsewhere classified (NEC)”, “URTIs”, and “URTIs (NEC)”.

Results

During almost 50,000 (∼46,978) patient-years of VDZ therapy, 40 serious and 68 non-serious LRTI events were reported in 106 patients; 54 events were pneumonia (n=34 serious; n=20 non-serious; ∼1 event/1000 patient-years of therapy). Regarding potential risk factors for pneumonia, 2 patients had undergone surgery ≤30 days prior to the event; 2 were current/former smokers (smoking history and prior surgery information not provided in 51/54 and 16/54 patients, respectively). Other LRTI events were: bronchitis (n=1 serious; n=26 non-serious); LRTIs (not otherwise specified; n=2 serious; n=20 non-serious); lung infection (n=2 serious; n=2 non-serious); lung abscess (n=1 serious; n=0 non-serious). Most LRTIs occurred ≥2 months after first VDZ infusion (n=32/108 events; not reported [NR] n=64/108 events). There were 4 serious and 313 non-serious URTIs in 300 patients, with nasopharyngitis the most frequently reported (n=201/317 events). Most URTIs occurred ≥2 months after first VDZ infusion (n=77/317 events; NR n=182/317 events). Patient demographics/clinical characteristics are shown (Table 1).

Table 1. Patient demographics and clinical characteristics

Conclusion

From almost 50,000 patient-years of VDZ therapy, RTIs (including pneumonia) were infrequent and most patients continued VDZ. These data represent experience of VDZ in a “real-world” setting and complement existing data from clinical trials. Limitations associated with PM safety reporting (incomplete data, voluntary reporting and difficulty establishing a causal relationship between drug and event) must be considered when interpreting these results.

References:

[1] Long MD, Martin C, Sandler RS, Kappelman MD., (2013), Increased Risk of Pneumonia among Patients with Inflammatory Bowel Disease, Am J Gastroenterol, 240–8