ObjectivesHerpes zoster (HZ) is caused by reactivation of varicella-zoster virus which remains latent in individuals after a varicella infection. It is expected that HZ will be more frequent in immunocompromised (IC) individuals than in immunocompetent (IC-free). This study assessed the incidence rate (IR) of HZ in individuals with a wide set of IC conditions and in IC-free individuals.SettingA retrospective cohort study was conducted in England using data (January 2000 to March 2012) from the Clinical Practice Research Datalink with linkage to the Hospital Episodes Statistics.ParticipantsA cohort of 621 588 individuals with 16 selected IC conditions and a gender/age-matched cohort of IC-free individuals were identified. The IC conditions included haematopoietic stem cell transplant (HSCT), solid organ transplant, malignancies, autoimmune diseases and users of immunosuppressive medications.OutcomesIR of HZ per 1000 person-years (PY) was estimated. Proportions of postherpetic neuralgia (PHN) and other HZ complications within 90 days of HZ onset were also estimated among patients with HZ. Risk factors for PHN in IC individuals with HZ were assessed by a multivariate regression model.ResultsThe overall IR of HZ in the IC cohort was 7.8/1000 PY (95% CI 7.7 to 7.9), increasing with age from 3.5/1000 PY (3.4–3.7) in individuals aged 18–49 years to 12.6/1000 PY (12.2–13.0) in individuals aged ≥80 years. This IR in the IC-free cohort was 6.2/1000 PY (6.1–6.3). The overall IR of HZ varied across IC conditions, ranging from 5.3 (5.1–5.5) in psoriasis to 41.7/1000 PY (35.7–48.4) in HSCT. The proportions of PHN and other HZ complications were 10.7% (10.2–11.1) and 2.9% (2.7–3.2) in the IC cohort, but 9.1% (8.7–9.5) and 2.3% (2.1–2.6) in the IC-free cohort, respectively.ConclusionIC population contributes to the public health burden of HZ in England. Vaccination might be the most preferable HZ preventive measure for the IC population.

Background and Methods:Limited data are available on the safety of fingolimod in pregnant women. We estimated the risk of adverse pregnancy outcomes in women with multiple sclerosis (MS) exposed to fingolimod either shortly before or during pregnancy in prospectively collected cases from clinical trials, observational studies, surveillance programs, and spontaneous reports.Results:The prevalence of major malformations among live births does not appear to be significantly higher than those in the general population and the unexposed MS population. Similarly, the prevalence of cardiac malformations observed in this analysis was not significantly different from that of the general population. Proportions of miscarriage were in line with those of the general and unexposed MS population and no specific pattern of birth defects was identified.Conclusions:These data can help inform healthcare professionals and women with MS exposed to fingolimod during conception.

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INTRODUCTION: Inflammatory bowel disease (IBD) patients in Western countries frequently experience suboptimal response to anti-tumor necrosis factor (TNF) treatment (Tx). The EXPLORE study aimed to assess the incidence and indicators of suboptimal response to first-line anti-TNF agents in IBD patients in real-world practice in newly industrialized countries, where data are limited. METHODS: A retrospective chart review study was conducted in Asia-Pacific (APAC; South Korea, China, Taiwan, Singapore), Latin America (LatAm; Argentina, Colombia, Mexico) and Russia-Middle East (RME; Russia, Saudi Arabia, Turkey) in adult patients diagnosed with ulcerative colitis (UC) or Crohn’s disease (CD), who initiated anti-TNF Tx between March 2010 and March 2015. The cumulative incidence (CI) of suboptimal response (Kaplan-Meier method) was assessed over the first 24 months of Tx, as the occurrence of a first indicator of: IBD-related hospitalization, dose escalation (increase in frequency and/or dose), discontinuation including switch to another anti-TNF, non-biologic Tx augmentation, or IBD-related surgery. Primary non-response (PNR) and secondary loss of response (SLOR) were defined as any suboptimal response indicator at < 4 and ≥4 months after anti-TNF initiation (excluding PNR patients), respectively. RESULTS: Overall, 1674 first-line anti-TNF treated patients (570 UC; 1104 CD) were included: male, UC 56.1%, CD 61.2%; median (min-max) age (years), UC 39.0 (18-82), CD 31.0 (19-83); median (min-max) disease duration (years), UC 3.0 (0-34), CD 1.0 (0-33); median (min-max) follow-up (months), UC 45.9 (24-60), CD 46.5 (14-60). At 24 months, the CI of suboptimal response to first anti-TNF Tx was 32.9% in UC and 41.2% in CD patients (unadjusted log-rank: P < 0.01); the APAC region had the highest CI (UC 45.1%; CD 54.1%) (Table 1). The CI of PNR was 13.6% and 16.9% in UC and CD patients, respectively. The CI of SLOR was 22.3% in UC and 29.2% in CD patients at 24 months. The most frequent first suboptimal response indicator was ‘IBD-related hospitalization’ (UC 33.0%; CD 36.1%) followed by ‘non-biologic augmentation’ (UC 30.3%; CD 23.8%) (Table 1). CONCLUSION: Suboptimal response to first-line anti-TNF agents is common in IBD patients in newly industrialized countries and is more frequently experienced in CD than in UC. Observed regional differences in the rates of suboptimal response, PNR and SLOR, may reflect local practice variations and restrictions in the management of anti-TNF treated patients.