Expert consensus on vaccination in patients with inflammatory bowel disease in Japan

Abstract

Immunosuppressive therapies can affect the immune response to or safety of vaccination in patients with inflammatory bowel disease (IBD). The appropriateness of vaccination should be assessed prior to the initiation of IBD treatment because patients with IBD frequently undergo continuous treatment with immunosuppressive drugs. This consensus was developed to support the decision-making process regarding appropriate vaccination for pediatric and adult patients with IBD and physicians by providing critical information according to the published literature and expert consensus about vaccine-preventable diseases (VPDs) [excluding cervical cancer and coronavirus disease 2019 (COVID-19)] in Japan. This consensus includes 19 important clinical questions (CQs) on the following 4 topics: VPDs (6 CQs), live attenuated vaccines (2 CQs), inactivated vaccines (6 CQs), and vaccination for pregnancy, childbirth, and breastfeeding (5 CQs). These topics and CQs were selected under unified consensus by the members of a committee on intractable diseases with support by a Health and Labour Sciences Research Grant. Physicians should provide necessary information on VPDs to their patients with IBD and carefully manage these patients’ IBD if various risk factors for the development or worsening of VPDs are present. This consensus will facilitate informed and shared decision-making in daily IBD clinical practice.

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

“…Live-attenuated vaccines against measles, rubella, mumps, or varicella viruses are contraindicated under immunosuppressive therapy, especially under biologic therapy. [15][16][17][18][19][20] In a previous review, 25 the safety of live-attenuated vaccination under immunosuppressive therapy was assessed in 20,556 patients with immune-mediated inflammatory diseases, including 2,852 IBD patients. Of these 20,556 patients, 474 received measles, mumps, and rubella (MMR) vaccination, and only 1 vaccine-induced infection was seen.…”

“…13,14 It is important to measure viral antibody titers and vaccinate if necessary prior to initiating immunosuppressive therapy. [16][17][18][19][20] However, even if antibody titers are measured prior to therapeutic intervention, most cases with moderate to severe disease do not allow sufficient time for vaccination. Our current study provides a possible solution of how to administer live-attenuated vaccines for those with negative antibody titers under immunosuppressive therapy by switching to VDZ treatment once disease activity is under control.…”

“…22,23 Using enzyme-linked immunosorbent assays (SRL Inc., Tokyo, Japan), specific IgG titers of < 2.0, 2.0-4.0, and > 4.0 IU/mL were considered seronegative, equivocal, and seropositive, respectively. 8 Considering the childhood immunization schedule in Japan, 8,20 patients with negative antibody titers and without a verified vaccination history were judged to be unimmunized. Even in cases with negative or equivocal immunity, certification of recommended childhood vaccinations was sufficient to be considered immunized.…”

“…To further reduce the risk of vaccination, thiopurines were also discontinued after discussion with the pa-tient. According to the recommended vaccination schedule, 15,17,20 if the patient had a history of childhood vaccination at 1 year of age or older, he or she was vaccinated once. If no history of childhood vaccination could be confirmed, he or she was vaccinated twice with an interval of at least 4 weeks.…”

“…[15][16][17] Live-attenuated vaccination is contraindicated for approximately 4 weeks prior to initiating or 3 months after discontinuing immunosuppressive agents. [15][16][17][18][19][20] Ideally, live-attenuated vaccines should be administered at the time of diagnosis or prior to the initiation of immunosuppressive therapy; however, in practice, there may be insufficient time for vaccination due to disease severity. After starting immunosuppressive therapy, drug cessation for vaccination may result in an increased risk of disease flare.…”