Intest Res.  2024 Jul;22(3):378-386. 10.5217/ir.2023.00203.

Live-attenuated vaccination in patients with inflammatory bowel disease while continuing or after elective switch to vedolizumab

• Shiga H
• Nagai H
• Shimoyama Y
• Naito T
• Moroi R
• Kakuta Y
• Kinouchi Y
• Masamune A

• KMID: 2558197
• DOI: http://doi.org/10.5217/ir.2023.00203

Abstract

Background/Aims
Vedolizumab (VDZ) is a gut-selective agent with a favorable safety profile. We aimed to assess the feasibility of elective switch from other advanced therapies to VDZ and subsequent live-attenuated vaccination while continuing VDZ in patients with inflammatory bowel diseases (IBD).
Methods
We measured antibody titers specific for measles, rubella, mumps, and varicella viruses in IBD patients under immunosuppressive therapy. Those with negative titers and without vaccination history were judged unimmunized. Patients were administered vaccines while continuing VDZ or switched to VDZ if receiving other advanced therapies and then administered vaccines. Co-primary outcomes were the rate of maintaining disease severity after vaccination and the rate without vaccine-induced infection.
Results
Among 107 unimmunized patients, 37 agreed to receive live-attenuated vaccines while continuing VDZ (17 patients) or after switching to VDZ (20 patients). In the 20 patients who electively switched to VDZ, disease severity was maintained except for 1 patient who developed intestinal infection. After 54 weeks, 18 patients (90%) continued to receive VDZ, excluding 2 patients who reverted to their originally administered biologics. In all 37 patients administered live-attenuated vaccines under VDZ treatment, disease severity was maintained after vaccination. Antibody titers became positive or equivocal in 34 patients (91.9%). There were no cases of vaccine-induced infection during a median observation period of 121 weeks.
Conclusions
While live-attenuated vaccines are contraindicated under immunosuppressive therapy, they may be safely administered while receiving VDZ immunotherapy. Switching from other advanced therapies to VDZ and subsequently receiving live-attenuated vaccines may be a safe alternative in unimmunized patients.

Keyword

Immunosuppressive therapy; Measles; Vaccination; Varicella zoster; Vedolizumab

Figure

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  Fig. 1. Patient flow in this study. Among 411 patients with inflammatory bowel diseases during immunosuppressive therapy, 107 patients were determined to be unimmunized for any 1 of 4 viral diseases (measles, rubella, mumps, and varicella). Of these 107 patients, 37 patients agreed to be vaccinated while continuing vedolizumab (17 patients) or after elective switch from another advanced therapy to vedolizumab (20 patients).

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  Fig. 2. Changes in disease severity before and after elective switch from another agent to vedolizumab. Advanced therapy was changed from another agent to vedolizumab in 20 patients. (A) In 16 patients with Crohn’s disease, Crohn’s Disease Activity Index (CDAI) was maintained from a median of 56 (IQR, 23-180) before switching to 51 (25–130) at 6 weeks and 52 (40–158) at 54 weeks. (B) In 4 patients with ulcerative colitis, the partial Mayo score remained from a median of 0.5 (IQR, 0–1) before switching to 0.5 (0–1) at 6 weeks and 0 (0–1) at 54 weeks. (C) The C-reactive protein (CRP) levels in all 20 patients slightly increased from a median of 0.04 (IQR, 0.02–0.19) before switching to 0.14 (0.02–0.50) at 6 weeks and 0.16 (0.03–0.31) at 54 weeks. IQR, interquartile range.

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  Fig. 3. Changes in disease severity before and after live-attenuated vaccination. A total of 37 patients (17 remaining on vedolizumab and 20 switched to vedolizumab) received live-attenuated vaccines. (A) In 23 patients with Crohn’s disease, Crohn’s Disease Activity Index (CDAI) was maintained from a median of 69.5 (IQR, 42-139) before vaccination to 52 (36–157) at 8 weeks and 65 (42–109) at 48 weeks. (B) In 14 patients with ulcerative colitis, the partial Mayo score remained from a median of 0 (IQR, 0–1) before vaccination to 0 (0–1) at 8 weeks and 0 (0–1) at 48 weeks. (C) The C-reactive protein (CRP) levels in all 37 patients were maintained from a median of 0.11 (IQR, 0.03–0.33) before vaccination to 0.11 (0.04–0.36) at 8 weeks and then slightly increased to 0.16 (0.05–0.42) at 48 weeks. IQR, interquartile range.

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