Among anti-TNF users in USA, mycobacterial disease rates are elevated, and NTM is associated with RA.

No consensus has previously been formed regarding the types and presentations of infectious pathogens to be considered as 'opportunistic infections' (OIs) within the setting of biologic therapy. We systematically reviewed published literature reporting OIs in the setting of biologic therapy for inflammatory diseases. The review sought to describe the OI definitions used within these studies and the types of OIs reported. These findings informed a consensus committee (infectious diseases and rheumatology specialists) in deliberations regarding the development of a candidate list of infections that should be considered as OIs in the setting of biologic therapy. We reviewed 368 clinical trials (randomised controlled/long-term extension), 195 observational studies and numerous case reports/series. Only 11 observational studies defined OIs within their methods; no consistent OI definition was identified across studies. Across all study formats, the most numerous OIs reported were granulomatous infections. The consensus group developed a working definition for OIs as 'indicator' infections, defined as specific pathogens or presentations of pathogens that 'indicate' the likelihood of an alteration in host immunity in the setting of biologic therapy. Using this framework, consensus was reached upon a list of OIs and case-definitions for their reporting during clinical trials and other studies. Prior studies of OIs in the setting of biologic therapy have used inconsistent definitions. The consensus committee reached agreement upon an OI definition, developed case definitions for reporting of each pathogen, and recommended these be used in future studies to facilitate comparison of infection risk between biologic therapies.

Background More than one million herpes zoster (HZ) cases occur in the United States every year. Currently, the live zoster vaccine is recommended for healthy older patients age ≥60 years. Whether the absolute risk for younger patients who have autoimmune or inflammatory conditions might be high enough to warrant vaccination of younger patients with these diseases is unclear. Objectives To evaluate the overall and age-stratified absolute incidence of HZ infections associated with different autoimmune and inflammatory diseases compared to the general population currently recommended for vaccination by the CDC. Methods We assembled 7 autoimmune and inflammatory disease cohorts using the Multi-Payer Claims Database (MPCD) using data from 2007-2010. All patients with at least one prescription and two diagnoses of RA, PsA, PsO, AS, IBD, SLE, gout were included and compared with two comparison cohorts: a cohort of diabetic patients and patients without any autoimmune disease or diabetes. Eligible patients in the nine cohorts were required to have at least 13 months continuous medical and pharmacy coverage. Patients were followed until they experienced HZ, died, lost coverage or December 31, 2010. We identified HZ using diagnosis codes and antiviral medication ±30 days. Age standardized incidence rates (IR) per 1,000 person-years were calculated for each cohort. Results The study population consisted of 66,941 subjects with RA, 4,460 with PsA, 5,986 with Pso, 1,891 with AS, 11,494 with IBD, 12,984 with SLE, 80,022 with gout, 192,676 with diabetes and 355,884 in the healthy cohort. The age standardized IRs among the 7 autoimmune and inflammatory disease cohorts (Table) ranged from a high of 14.1 per 1,000 person years (SLE) to a low of 3.9 (gout). For diabetes, the associated age-standardized rate was 3.5/1000 and for healthy cohorts was 3.0/1000. The age-specific rate of HZ for RA, IBD and SLE patients age ≥40 was greater than the corresponding rate in healthy individuals age ≥60. Table 1. Age, gender standardized incidence rate for herpes zoster per 1000 pys Cohorts All Male Female SLE 14.1 7.2 6.4 IBD 8.4 5.4 3.3 RA 7.5 4.6 1.9 Psa 4.7 3.9 0.7 PsO 4.7 3.8 0.9 AS 4.1 4.5 0.5 Gout 3.9 2.9 1.2 Diabetes 3.5 1.6 1.1 Healthy 3.0 1.5 0.5 Conclusions SLE, IBD and RA are associated with an increased incidence rate of HZ infection compared to healthy older people. Based upon comparable absolute risk to healthy individuals age ≥60, SLE, IBD and RA patients age ≥40 might reasonably be considered as appropriate candidates for vaccination for HZ. Disclosure of Interest J. Curtis Grant/research support: Research grants and/or consulting for unrelated work with Amgen, Abbott, BMS, Celgene, Centocor, CORRONA, Crescendo, Genentech, Janssen, Pfizer, Roche, UCB, H. Yun Grant/research support: unrelated work from AMGEN, S. Yang: None declared, L. Chen: None declared, K. Winthrop Grant/research support: Research grants and/or consulting for unrelated work with Pfizer, UCB, Genentech, F. Xie: None declared...

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OBJECTIVES:To review the changes in HIV in terms of course of the disease over the past five years and its consequences, to assess whether existing economic models in HIV would need to be updated to account for these changes in case these were used for the economic evaluation of new treatments in HIV. METHODS: A systematic literature review was carried out in PubMed, using both MeSH and key words, focusing on the following areas: opportunistic infections (OIs), health consequences, costs, quality of life, adherence and compliance and efficacy of treatments. In addition, current guidelines were identified and reviewed. For treatments we focussed on maraviroc, etravirine and raltegravir. RESULTS: At total of 1787 hits were obtained from the above-mentioned strategy. Finally data on 341 articles extracted. For treatments, data from six trials on efficacy and adverse event data were extracted and used in a meta-analysis (not reported here). In terms of OIs it was clear that fewer patients suffer from these infections compared to the early 2000s. Data on costs indicated that new costs were available by CD4 cell count. There are substantial new data available on quality of life in HIV, however, with several publications providing data by CD4-cell strata. Data on health consequences showed that patients increasingly live long enough to suffer from LT health consequences such as cardiovascular disease and cancer. Guidelines indicated that treatment algorithms had changed markedly in the last five years and that comparison to OBT is no longer an acceptable comparator strategy in economic modelling. CONCLUSIONS: The management of HIV has changed substantially since 2006. Patients live longer, are healthier and suffer from "common" health consequences such a cardiovascular disease and cancer. Any health economic model in this disease area should take these aspects into consideration.