Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Vaccination failure; diagnosed with disseminated herpes zoster/ severe HZ; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Zoster vaccine) for prophylaxis. Literature Reference. Co-suspect products included Herpes zoster (Zoster vaccine) for prophylaxis, prednisolone for crohn's disease, vedolizumab for crohn's disease and upadacitinib for crohn's disease. The patient's past medical history included stricturoplasty. Previously administered products included MERCAPTOPURINE with an associated reaction of drug ineffective, infliximab with an associated reaction of drug ineffective and ustekinumab with an associated reaction of drug ineffective. Concurrent medical conditions included crohn's disease (30-year history), ileal resection, crohn's disease aggravated, bloody diarrhea, abdominal pain, bloody diarrhea and inflammatory bowel disease. On an unknown date, the patient received Zoster vaccine and Zoster vaccine. In JUL-2023, the patient started prednisolone. On an unknown date, the patient started vedolizumab. In SEP-2023, the patient started upadacitinib (oral) 45 mg once a day (45 mg daily). The dose was changed to 30 mg once a day (30 mg daily). The dose was changed to 45 mg once a day (45 mg daily). On an unknown date, an unknown time after receiving Zoster vaccine and Zoster vaccine, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria hospitalization and GSK medically significant) and herpes zoster disseminated (Verbatim: diagnosed with disseminated herpes zoster/ severe HZ) (serious criteria hospitalization and GSK medically significant). The patient was treated with aciclovir (Acyclovir), valaciclovir (Valacyclovir) and risankizumab. Prednisolone was discontinued. Vedolizumab was discontinued. Upadacitinib was discontinued. The outcome of the vaccination failure was not reported and the outcome of the herpes zoster disseminated was resolving. The reporter considered the vaccination failure and herpes zoster disseminated to be related to Zoster vaccine and Zoster vaccine. The company considered the vaccination failure and herpes zoster disseminated to be unrelated to Zoster vaccine and Zoster vaccine. Additional Information: GSK receipt date: 03-FEB-2025 Author reported a 60-year-old female patient with a 30-year history of refractory Crohn's disease (CD) requiring ileocolic resection, multiple stricturoplasties, and failed medical treatment with mercaptopurine (6-MP), infliximab, ustekinumab, and vedolizumab who presented with disseminated Herpes zoster (HZ) while on upadacitinib. For context, the patient began having worsening CD symptoms while on vedolizumab in July of 2023 and was initiated on a prednisolone course with a slow taper. patient received first dose of the Recombinant Zoster Vaccine (RZV) while on prednisolone and vedolizumab. Two months later, patient developed frequent, bloody diarrhea and was transitioned from vedolizumab to upadacitinib. During the 12- week upadacitinib induction (45 mg/d) period and ongoing taper of prednisolone, patient received second dose of the RZV. patient was tapered to 30 mg/d of upadacitinib, but after 3 months had recurrence of abdominal pain, bloody diarrhea, and an elevated fecal calprotectin concerning for a CD flare. Upadacitinib was increased back to 45 mg/d, and, after 3 weeks, patient had symptomatic remission. patient completed prednisolone taper in March of 2024. In July of 2024, the patient presented to the emergency department and was found to be febrile and have a diffuse vesicular/bullous facial rash that crossed the midline with oral involvement and lesions of the right medial thigh, bilateral arms, bilateral groin, and across patient back. At the time of presentation, patients CD therapy was 45 mg/day of upadacitinib monotherapy. patient was diagnosed with disseminated HZ by Varicella zoster virus (VZV) polymerase chain reaction of the lesions and blood. patient was admitted to the hospital and ultimately treated with intravenous acyclovir for 8 days until all lesions had crusted over before transitioning to a 1-week course of high-dose oral valacyclovir, followed by an indefinite course of suppressive valacyclovir. Upadacitinib was held during hospitalization and on discharge. patient was discharged after 11 days. As an outpatient, after remaining off all immunosuppressive therapy for CD for a month and a half, patient was initiated on risankizumab and has remained in clinical remission. The lifetime risk of developing HZ increases with age (due to a decline in cell-mediated immunity), in female gender, in adults with IBD, and with exposure to immunosuppressive therapy. Completion of the two-dose RZV has been shown to have between 76 percent and 97 percent vaccine effectiveness in large cohort studies and is known to lower long-term risk of HZ in older patients with inflammatory bowel disease (IBD). However, despite RZV, this patient still developed severe HZ, in part due to patients multiple risk factors as detailed above, in addition to the fact that patient was on immunosuppressive therapy at the time of RZV (first dose on prednisolone and vedolizumab and second dose on prednisolone and upadacitinib). Although some of these studies examined non-IBD populations and non-RZV vaccines, the concept of decreased immunogenic response due to immunosuppressive therapy at the time of vaccination likely applies to this patient. The data suggest that patient may have had a blunted immune response to the RZV, given patient was on immunosuppressive therapy at the times of both vaccine administrations. This likely made patient more susceptible to HZ infection. presented a rare case of severe HZ in a patient with refractory CD on upadacitinib requiring inpatient management and transition of CD therapy. Notably, patient had completed the RZV and was on immunosuppressive agents at the time of vaccination In conclusion, the RZV has demonstrated clear benefit in reducing the risk of developing HZ in patients with IBD; however, this case demonstrates that consideration of individual risk factors of HZ, including immunosuppressive therapy at times of RZV, should be considered before initiation of a JAKi. This article corresponding to this case is not available for regulatory submission due to copyright restriction.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset) is considered unrelated to GSK Zoster vaccine. Herpes zoster disseminated is an unlisted event which is considered unrelated to GSK Zoster vaccine.
Abdominal pain; Bloody diarrhea; Crohn's disease (30-year history); Crohn's disease aggravated; Inflammatory bowel disease
Medical History/Concurrent Conditions: Ileal resection; Stricturoplasty
PREDNISOLONE; VEDOLIZUMAB; UPADACITINIB
Test Name: Body Temperature; Result Unstructured Data: (Test Result:found to be febrile,Unit:unknown,Normal Low:,Normal High:); Test Date: 202403; Test Name: fecal calprotectin; Result Unstructured Data: (Test Result:was elevated,Unit:unknown,Normal Low:,Normal High:); Test Date: 202403; Test Name: VZV polymerase chain reaction; Result Unstructured Data: (Test Result:diagnosed with disseminated Herpes Zoster,Unit:unknown,Normal Low:,Normal High:)