Opportunistic Infections and Autoimmune Diseases

Faria, Raquel; Pereira, Carlos; Alves, Rute; Mendonça, Teresa; Farinha, Fátima; Vasconcelos, Carlos

doi:10.1016/b978-0-444-63269-2.00018-0

Cited by 1 publication

(2 citation statements)

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“…4,5 The strengths of this study include the extensive patient-years of exposure, the large total number of patients and the data reported across an international setting. Limitations of postmarketing data from the VGSD should be considered when interpreting these findings, which 5210 [17] 456 [16] 490 [15] 4849 [17] 511 [17] 341 [15] Malignancies 2631 [8] 228 [8] 205 [6] 2420 [8] 233 [8] 159 [7] Serious infections Pregnancy 285 [31] Pregnancy 215 [29] No adverse event c 205 [22] No adverse event 179 [24] Off-label use c 45 [5] Pregnancy of partner 37 [5] Abortion spontaneous 29 [3] Off-label use 30 [4] Exposure during pregnancy;…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

The Safety Profile of Vedolizumab in Ulcerative Colitis and Crohn’s Disease: 4 Years of Global Post-marketing Data

Cohen

Bhayat

Blake

et al. 2019

Journal of Crohn's and Colitis

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Background and Aims Vedolizumab is a gut-selective antibody to α 4 β 7 integrin, approved to treat moderate-to-severe ulcerative colitis and Crohn’s disease in adults. Clinical trial data on patients meeting protocol-specified criteria may not reflect real-world clinical practice. This is a descriptive analysis of 4 years of post-marketing safety data on vedolizumab. Methods The Vedolizumab Global Safety Database contains all adverse event reports collated by Takeda Pharmaceutical Company Ltd since vedolizumab approval [May 20, 2014]. Adverse event reports received between approval and May 19, 2018 were identified using Medical Dictionary for Regulatory Activities version 21.0 Preferred Terms. Adverse event frequencies were calculated and categorised. Results In approximately 208 050 patient-years of vedolizumab exposure, 32 752 patients reported 80 218 events. In patients with Crohn’s disease or ulcerative colitis, 37 662 and 34 259 events occurred in 14 191 and 14 042 patients, respectively, and 8297 events occurred in 4519 individuals with other [off-label] or unreported indications. Overall, 5230 [14%; Crohn’s disease] and 3580 [10%; ulcerative colitis] events were serious. Most frequently reported were gastrointestinal events (Crohn’s disease, 6156 [16%]; ulcerative colitis, 5701 [17%]). Patients with Crohn’s disease or ulcerative colitis reported 251 malignancies [<1%], 402 hepatobiliary events [<1%], and 5876 infections (1137 serious [19%], 301 opportunistic [5%]). Patients aged ≥70 years [2326 patients] reported <10% of events. Conclusions Adverse event patterns were consistent with clinical trials, with no new safety concerns. Most reported events were non-serious and event frequency was low, considering patient-years of exposure. Although limitations of post-marketing safety reports require acknowledgement, these real-world data support a favourable safety profile of vedolizumab.

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Section: Discussionmentioning

confidence: 99%

“…Opportunistic infections may be defined as infections caused by microorganisms that are normally non-pathogenic, but are able to cause serious disease when the immune system is impaired as a result of another unrelated disease or its treatment. 23,24 When considering only…”

Section: Opportunistic Infectionsmentioning

confidence: 99%