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Herpes Zoster Risk in Patients with Rheumatoid Arthritis and Its Association with Medications Used.

ABSTRACT: Rheumatoid arthritis (RA) was associated with the risk of incident herpes zoster (HZ), which might be influenced by medication use by RA patients. We aimed to investigate the association of RA with the risk of incident HZ and how the HZ risk effected by RA medications in CIC RA patients. We conducted an observational study including population-based representative insurance claims data of 19,673 patients with RA and 39,346 matched patients without RA during 1997-2010 from the Taiwan National Health Insurance Research Database; we identified 1651 patients with catastrophic illness-certified (CIC) RA and 11,557 matched patients with non-CIC RA. Exploratory analyses assessed the association between RA/CIC RA and risk of incident HZ and its complications. The association of prescribed medications with HZ risk in CIC RA patients was also estimated. The incidence rates of HZ were higher in CIC RA patients and non-CIC RA than in the matched people without RA (21.95 and 14.03 vs. 7.36 events per 1000 person-years, respectively). The adjusted incidence rate ratio (95% confidence interval (CI)) for HZ was 1.74 (1.65-1.84) in RA patients vs. matched non-RA and 1.65 (1.44-1.89) in CIC RA patients vs. non-CIC RA. For HZ complications, RA had a 2.85-fold higher risk than non-RA, and CIC RA had a 1.78-fold higher risk than non-CIC RA. Moreover, in CIC RA patients, prednisolone use was associated with incident HZ risk compared with prednisolone nonuse (adjusted odds ratio 1.48, 1.08-2.03); prolonged prednisolone use (approximately 5 years) increased the risk (adjusted odds ratio 2.16, 1.46-3.19). Our results suggested that RA was positively associated with HZ risk, particularly in RA patients with prednisolone use.

SUBMITTER: Dlamini ST

PROVIDER: S-EPMC9915285 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Herpes Zoster Risk in Patients with Rheumatoid Arthritis and Its Association with Medications Used.

Dlamini Sithembiso Tiyandza ST Htet Kyaw Moe KM Theint Ei Chue Chue ECC Mayadilanuari Aerrosa Murenda AM Li Wei-Ming WM Tung Yi-Ching YC Tu Hung-Pin HP

International journal of environmental research and public health 20230124 3

Rheumatoid arthritis (RA) was associated with the risk of incident herpes zoster (HZ), which might be influenced by medication use by RA patients. We aimed to investigate the association of RA with the risk of incident HZ and how the HZ risk effected by RA medications in CIC RA patients. We conducted an observational study including population-based representative insurance claims data of 19,673 patients with RA and 39,346 matched patients without RA during 1997-2010 from the Taiwan National Hea ...[more]

PMID: 36767490

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Project description:ObjectivePatients with rheumatoid arthritis (RA) are at increased risk for herpes zoster (HZ) (i.e., shingles). The aim of this study was to determine whether treatment with tofacitinib increases the risk of HZ in patients with RA.MethodsHZ cases were identified as those reported by trial investigators from the databases of the phase II, phase III, and long-term extension (LTE) clinical trials in the Tofacitinib RA Development Program. Crude incidence rates (IRs) of HZ per 100 patient-years (with 95% confidence intervals [95% CIs]) were calculated by exposure group. Logistic regression analyses were performed to evaluate potential risk factors for HZ (e.g., age, prednisone use).ResultsAmong 4,789 participants, 239 were identified as having tofacitinib-associated HZ during the phase II, phase III, and LTE trials, of whom 208 (87%) were female and whose median age was 57 years (range 21-75 years). One HZ case (0.4%) was multidermatomal; none of the cases involved visceral dissemination or death. Twenty-four patients with HZ (10%) permanently discontinued treatment with tofacitinib, and 16 (7%) were either hospitalized or received intravenous antiviral drugs. The crude HZ IR across the development program was 4.4 per 100 patient-years (95% CI 3.8-4.9), but the IR was substantially higher within Asia (7.7 per 100 patient-years, 95% CI 6.4-9.3). Older age was associated with HZ (odds ratio 1.9, 95% CI 1.5-2.6), and IRs for HZ were similar between patients receiving 5 mg tofacitinib twice daily (4.4 per 100 patient-years, 95% CI 3.2-6.0) and those receiving 10 mg twice daily (4.2 per 100 patient-years, 95% CI 3.1-5.8). In the phase III trials among placebo recipients, the incidence of HZ was 1.5 per 100 patient-years (95% CI 0.5-4.6).ConclusionIn the Tofacitinib RA Development Program, increased rates of HZ were observed in patients treated with tofacitinib compared with those receiving placebo, particularly among patients within Asia. Complicated HZ among tofacitinib-treated patients was rare.

Project description:IntroductionRisk of herpes zoster (HZ) is increased with Janus kinase inhibitor use. We evaluated clinical study data relating to HZ management in patients with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) receiving tofacitinib.MethodsThis post hoc analysis included data from 21 RA and 3 PsA clinical studies; data were pooled for tofacitinib doses. Outcomes of HZ events (serious and non-serious) and tofacitinib treatment changes were evaluated in response to first and second HZ events. Median time to resolution was stratified by dermatomal involvement, history of HZ prior to tofacitinib, changes to tofacitinib treatment, anti-viral and corticosteroid use, and tofacitinib dose.ResultsSeven hundred eighty-three (11.1%, N = 7061) patients with RA experienced ≥ 1 HZ event, 63 (8.0%) of whom had ≥ 2 HZ events. In patients with PsA, 36 (4.6%, N = 783) experienced ≥ 1 HZ event, 1 (2.8%) of whom had ≥ 2 HZ events. For most HZ events, tofacitinib treatment was unchanged or temporarily discontinued. The majority of patients received anti-viral treatment, most within 3 days of onset. Post-herpetic neuralgia developed in 6.9% and 3.2% of patients with RA with first and second events, respectively, and in 2.8% of patients with PsA with a first event. Most first and second events resolved (RA: 97.6% and 96.8%, respectively; PsA: 94.4% and 100%, respectively). Median time to resolution was 22.0 days for first and 15.0 days for second events for RA and 20.5 days for first and 11.0 days for second events (n = 1) for PsA. Time to resolution of first events for RA and PsA was generally numerically shorter for patients with single dermatomal HZ, history of HZ, or anti-viral use versus those without.ConclusionAmong patients receiving tofacitinib, recurrent events were more common in patients with RA versus PsA; HZ duration was shorter for repeat events.Trial registrationNCT01262118, NCT01484561, NCT00147498, NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT01164579, NCT00976599, NCT01059864, NCT01359150, NCT02147587, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01039688, NCT02187055, NCT00413699, NCT00661661, NCT01877668, NCT01882439, NCT01976364.

Project description:ImportanceThe recombinant zoster vaccine (RZV) is currently recommended for immunocompetent adults aged 50 years or older and immunocompromised adults aged 19 years or older and is effective in preventing herpes zoster ophthalmicus (HZO). However, questions about the safety of RZV in patients with a history of HZO remain.ObjectiveTo evaluate whether there is an increased risk of HZO recurrence after RZV in patients with a history of HZO.Design, setting, and participantsThis retrospective cohort study used medical and outpatient pharmacy claims data for commercial and Medicare Advantage enrollees from the Optum Labs Data Warehouse. Patients with incident HZO from January 1, 2010, to December 31, 2021, were identified; the study period ended on March 31, 2022. The vaccinated group consisted of patients with at least 1 dose of RZV more than 90 days following the initial HZO diagnosis. The unvaccinated group consisted of patients without any record of RZV in the study period. Vaccinated and unvaccinated patients were matched using exact k:1 matching without replacement.ExposureRecombinant zoster vaccination.Main outcomes and measuresThe main outcome was the number of HZO recurrences with and without RZV exposure.ResultsA total of 16 408 patients were included in the matched analysis, of whom 12 762 were unvaccinated (7806 [61.2%] female; mean [SD] age at diagnosis, 68.8 [10.3] years) and 3646 were vaccinated (2268 [62.2%] female; mean [SD] age at diagnosis, 67.4 [9.8] years). Within the primary risk period of 56 days after the index date (ie, the start of follow-up for the outcome), the incidence of HZO recurrence after any RZV exposure was 37.7 per 1000 person-years compared with 26.2 per 1000 person-years in the unexposed group. After controlling for race and ethnicity, inpatient stays, emergency department visits, concomitant vaccines, and eye care practitioner visits, the association between vaccination status and HZO exacerbation in the primary risk period had an adjusted hazard ratio for any RZV exposure of 1.64 (95% CI, 1.01-2.67; P = .04).Conclusions and relevanceIn this study, RZV exposure was associated with a higher likelihood of HZO recurrence in patients with a history of HZO compared with no RZV exposure. These findings support consideration that patients with a history of HZO may benefit from monitoring after receiving RZV in case of HZO recurrence.

Dataset Information

Herpes Zoster Risk in Patients with Rheumatoid Arthritis and Its Association with Medications Used.

Publications

Herpes Zoster Risk in Patients with Rheumatoid Arthritis and Its Association with Medications Used.

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