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Miscellaneous Drugs during Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
Vedolizumab is a monoclonal antibody used to treat ulcerative colitis and Crohn’s disease. A meta-analysis of vedolizumab use during the first trimester found that the frequency of birth defects (1 percent, 95 percent CI: 0–4 percent) was not increased among 120 infants (from 5 studies) was not increased (Nielsen et al., 2020).
Inflammatory Bowel Disease
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Vedolizumab: This is a humanized monoclonal IgG1 antibody approved for use in CD. There is limited data to support the safety of vedolizumab use in pregnancy [96, 97]. Similar to natalizumab, there are concerns regarding effects on the neonatal immune system response. To alleviate these concerns, consideration can be given to administer the last dose 6–10 weeks before delivery [97]. While vedolizumab appears to be compatible with breastfeeding, data is very limited and warrants careful counseling [96, 97]. Pediatric or neonatology consultation can be offered to discuss vaccination risks.
Case 15
Published in Andrew Solomon, Julia Anstey, Liora Wittner, Priti Dutta, Clinical Cases, 2021
Andrew Solomon, Julia Anstey, Liora Wittner, Priti Dutta
There are other medications which may be used by specialists, such as:Immunosuppressant drugs, e.g. tacrolimus and ciclosporin are both used for UCMonoclonal antibodiesAnti-TNF agents, e.g. infliximab and adalimumab may be used to induce remission in severe CD that has not responded to other treatments. It is rarely needed as maintenance treatmentVedolizumab is an integrin α4β7 monoclonal antibody used in the treatment of severe CD and UC
Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study
Published in Scandinavian Journal of Gastroenterology, 2020
Jonathan R. White, Said Din, Richard J. M. Ingram, Stephen Foley, Mohammad Aftab Alam, Richard Robinson, Rodric Francis, Emily Tucker, Mustafa Jalal, David Elphick, Edmond Atallah, Anthony Norman, Muhammad Amin, Aamir Sajjad, Nicola Heggs, Simon Meadowcroft, Gordon W. Moran
Patients (53%) had at least one hospital admission in the 12 months preceding vedolizumab commencement. This reduced to 30% during the observation period. The mean rate of IBD-related hospital admissions prior to vedolizumab initiation per patient per year for CD and UC was 1.0 (IQR 0–1.0) and 0.9 (IQR 0–2.0), respectively. Following vedolizumab initiation, median rate of hospitalisation for CD and UC were 1.0 (IQR 0–1.0) and 1.0 (IQR 0–1.0), respectively. Twenty-six patients had IBD related surgery (12 patients with CD and 14 patients with UC) during the observation period after initiation of vedolizumab. Four of these patients had two surgical procedures. Overall, 12 adverse events were recorded in patients receiving vedolizumab during the study observation period. The most common was intolerance of vedolizumab (n = 5) (Table 4). About 9% of patients were admitted with infections, with respiratory tract infections being the most common. Three patients were diagnosed with a malignancy during the observation period. One patient was diagnosed with basal cell carcinoma and treated with surgery. They received 14 doses of vedolizumab which was later stopped due to loss of response. Another patient who received four doses of vedolizumab (which was later stopped due to non-response) was diagnosed with acute myeloid leukaemia and was started on chemotherapy. The final patient underwent a prostatectomy for prostate cancer. The vedolizumab was continued for more than 12 months by the end of the observation period.
Higher vedolizumab serum levels do not increase the risk of adverse events in patients with inflammatory bowel disease
Published in Scandinavian Journal of Gastroenterology, 2020
Neil K. Sengupta, Ahmad Azizov, Smita Halder, Ted Xenodemetropoulos, David Armstrong, Frances Tse, John K. Marshall, Neeraj Narula
No study to date has investigated the relationship of adverse reactions with respect to vedolizumab serum concentrations. The landmark studies [3,4] and subsequent real-world cohorts [8,21] have reported rates of adverse events with vedolizumab at approximately 25–30% of users, consistent with our findings. Gut selective alpha integrin inhibitors such as vedolizumab are generally thought to have favourable safety profiles compared to TNFα inhibitors. However, they may be associated with risk of certain adverse events, such as nasopharyngitis and infectious colitis [22]. The rates of serious adverse events are also higher with treatment using vedolizumab than to placebo [3,4]. However, recent work from the VICTORY study has suggested that vedolizumab adverse events may be as low as 6 in 1000 infusions [23]. The present study identified no significant difference in adverse events between the higher serum level cohort and the lower serum level cohort, and provides further evidence supporting the safety profile of vedolizumab.
Special considerations for biologic medications in pediatric ulcerative colitis
Published in Expert Opinion on Biological Therapy, 2020
Logan Jerger, Jeffrey S. Hyams
Given its effectiveness in adults with IBD, this medication has been used in pediatric patients, including both Crohn’s disease and UC. One multicenter, retrospective study evaluated its use in pediatric IBD, and when stratifying data for pediatric UC, 76% of patients were found to be in clinical remission based on PUCAI [48]. In both Crohn’s disease as well as UC, this study found that in the pediatric population, patients with colon-only disease had higher rates of remission at multiple time points during the study. An additional discussion point worth noting here is that anti-TNF-naïve patients had statistically significantly higher rates of remission (100% vs. 45%; p = 0.04). During the study period, safety was also illustrated with a lack of serious adverse events. The results were also evidenced by smaller studies as well, including those with prior anti-TNF-α failure [49,50]. From this literature, the use of vedolizumab, particularly in colonic disease, has been suggested as beneficial with limited side effects noted as well. It is also worth mentioning that limited data support its use in those not responding to anti-TNF-α biologic medications. However, controlled trial data are lacking and further studies are needed.