Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease

Satyam, Venkata R.; Li, Pei-Hsuan; Reich, Jason; Qazi, Taha; Noronha, Ansu; Wasan, Sharmeel K.; Farraye, Francis A.

doi:10.1007/s10620-019-06016-4

Cited by 29 publications

(18 citation statements)

References 27 publications

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“…85 On the other hand, the response appears to improve with second vaccination in studies evaluating influenza 85 and hepatitis A 86 vaccines in patients receiving methotrexate (15-20 mg per week), 85,86 azathioprine, or cyclosporine. 85,87,88 Satisfactory immune responses to influenza vaccine and nonviral vaccine (PPSV23, tetanus toxoid) in JAK inhibitoretreated patients with rheumatoid arthritis 89 and inflammatory bowel disease have been observed when vaccines were administered either before the initiation of therapy [90][91][92][93] or after temporary withdrawal of JAK inhibitors 2 to 3 weeks before vaccination, 89,94,95 which is consistent with most consensus guideline recommendations. 3,70,71 Overall, vaccine efficacy may be reduced in patients receiving systemic immune-targeting therapies because of the impaired immune response in these patients; however, temporary withdrawal and/or additional vaccinations may be considered to achieve adequate protection.…”

Section: Systemic Immunotherapies and Vaccinesmentioning

confidence: 59%

An evidence-based guide to SARS-CoV-2 vaccination of patients on immunotherapies in dermatology

Gresham

Marzario

Dutz

et al. 2021

Journal of the American Academy of Dermatology

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Immune-mediated diseases and immunotherapeutics can negatively affect normal immune functioning and, consequently, vaccine safety and response. The COVID-19 pandemic has incited research aimed at developing a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. As SARS-CoV-2 vaccines are developed and made available, the assessment of anticipated safety and efficacy in patients with immune-mediated dermatologic diseases and requiring immunosuppressive and/or immunomodulatory therapy is particularly important. A review of the literature was conducted by a multidisciplinary committee to provide guidance on the safety and efficacy of SARS-CoV-2 vaccination for dermatologists and other clinicians when prescribing immunotherapeutics. The vaccine platforms being used to develop SARS-CoV-2 vaccines are expected to be safe and potentially effective for dermatology patients on immunotherapeutics. Current guidelines for the vaccination of an immunocompromised host remain appropriate when considering future administration of SARS-CoV-2 vaccines.

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Section: Systemic Immunotherapies and Vaccinesmentioning

confidence: 59%

An evidence-based guide to SARS-CoV-2 vaccination of patients on immunotherapies in dermatology

Gresham

Marzario

Dutz

et al. 2021

Journal of the American Academy of Dermatology

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“…Further, herpes zoster is theoretically preventable with vaccination, and guidance on the management and prevention of herpes zoster in such patients has recently been published. 30 For example, one option to reduce herpes zoster risk in susceptible patients is vaccination with the newly developed non-live herpes zoster vaccine, Shingrix [zoster vaccine recombinant, adjuvanted; GlaxoSmithKline] 43 ; however, there are currently limited published data on the safety of this adjuvanted vaccine or its effectiveness in patients with immune-mediated inflammatory diseases such as UC, 44 or in patients receiving tofacitinib. The live vaccine, Zostavax (shingles [herpes zoster] vaccine live; MSD), also remains an option and appeared to be safe and adequately immunogenic in a study of patients with RA, when given 2–3 weeks before starting tofacitinib.…”

Section: Discussionmentioning

confidence: 99%

Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Infection Rates from the Ulcerative Colitis Clinical Programme

Winthrop

Loftus

Baumgart

et al. 2020

Journal of Crohn's and Colitis

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Background and Aims Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis. We report integrated analyses of infections in the Phase [P]2 and P3 OCTAVE programmes. Methods Three cohorts were analysed: Induction [P2/3 induction studies]; Maintenance [P3 maintenance study]; and Overall [all tofacitinib-treated patients in induction, maintenance or ongoing, open-label, long-term extension studies; as of May 2019]. Proportions and incidence rates [IRs; unique patients with events/100 patient-years] of serious infections [SIs], herpes zoster [HZ] [non-serious and serious] and opportunistic infections [OIs] are reported [censored at time of event]. Results In the Induction Cohort [N=1220], no patients receiving placebo and eight [0.9%] receiving tofacitinib 10mg twice daily [BID] developed SIs. Maintenance Cohort [N=592] SI IRs [95% CI] were 1.94 [0.23–7.00] for placebo, and 1.35 [0.16–4.87] and 0.64 [0.02–3.54] for tofacitinib 5 and 10mg BID, respectively; HZ IRs were 0.97 [0.02–5.42], 2.05 [0.42–6.00] and 6.64 [3.19–12.22], respectively. In the Overall Cohort [N=1157; 82.9% predominantly received tofacitinib 10mg BID], SI, HZ and non-HZ OI IRs were 1.70 [1.24–2.27], 3.48 [2.79–4.30] and 0.15 [0.04–0.38], respectively. No SIs resulted in death. Conclusions During induction, SIs were more frequent with tofacitinib versus placebo. SIs were generally infrequent in the Maintenance and Overall Cohorts, with rates comparable between treatment groups. Maintenance Cohort HZ IR was numerically higher with tofacitinib 10 versus 5mg BID. Overall Cohort HZ IRs remained stable over time. Non-HZ OIs and viral infections were rare.

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“…As an alternative, an adjuvanted recombinant Zoster vaccine (RZV) has been developed and was first approved in Canada followed by the US in 2017 for its use in adults aged 50 years and older [20,21]. Clinical studies on immunogenicity, safety and efficacy of RZV have been completed or are ongoing for different IC conditions such as HIV, haematopoietic stem cell transplant (HSCT) or transplant recipients or Inflammatory bowel disease (IBD) [22][23][24][25]. Their results will allow broadening the approved indication of RZV [21].…”

Section: Introductionmentioning

confidence: 99%

Herpes zoster risk and burden of disease in immunocompromised populations: a population-based study using health system integrated databases, 2009–2014

et al. 2020

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Background Estimate the incidence of herpes zoster (HZ), its complications and healthcare utilization rates in adults (≥ 18-years-old) with a wide range of immunocompromised (IC) conditions compared to IC-free cohort. Method A population-based retrospective study using the Valencia healthcare Integrated Databases (VID) (2009–2014). HZ and IC were defined using ICD-9 codes in primary care (PC) and hospitalization registers. Incidence rates (IR), risk of HZ, HZ-recurrence, HZ-complications and healthcare utilization rates were estimated in the IC-cohort compared to IC-free. Results The study population consisted of 4,382,590 subjects, of which 578,873 were IC (13%). IR (in 1000 persons-year) of HZ overall, in IC and in IC-free cohort was 5.02, 9.15 and 4.65, respectively. IR of HZ increased with age in both cohorts and it was higher for all IC conditions studied, reaching up to twelvefold in subjects with stem cell transplantation. IC subjects had 51% higher risk of developing HZ, 25% higher HZ-recurrence and the risk of HZ-complications was 2.37 times higher than in IC-free. HZ-related healthcare utilization was higher in the IC-cohort than in IC-free (number of hospitalizations 2.93 times greater, hospital stays 12% longer, 66% more HZ-specialist visits, 2% more PC visits, sick leaves 18% longer and 20% higher antiviral dispensation). Conclusions Patients suffering from all the IC conditions studied are at higher risk of developing HZ, HZ-recurrence and post-herpetic complications, which implies a substantial morbidity and a high consumption of resources. These results should be considered for vaccine policy implementation.

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Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease

Cited by 29 publications

References 27 publications

An evidence-based guide to SARS-CoV-2 vaccination of patients on immunotherapies in dermatology

An evidence-based guide to SARS-CoV-2 vaccination of patients on immunotherapies in dermatology

Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Infection Rates from the Ulcerative Colitis Clinical Programme

Herpes zoster risk and burden of disease in immunocompromised populations: a population-based study using health system integrated databases, 2009–2014

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