Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial.

OBJECTIVE: The delivery of healthcare at home has expanded to intravenous infusions of monoclonal antibodies. A recently developed model of care for home infusions of natalizumab for people with relapsing-remitting multiple sclerosis was evaluated. This pilot study of home infusions of natalizumab and usual care (attendance in a hospital out-patients' clinic) compared safety, feasibility, patient satisfaction, effectiveness and costs. METHODS: In this randomised AB/BA crossover trial, 37 adults were randomised to usual care (n = 19) or home infusions (n = 18). After three infusions, patients crossed over to the alternate treatment for another three infusions. Patient safety outcomes and adherence, satisfaction, quality of life, disability and costs were compared. RESULTS: No adverse events were recorded from 207 infusions from 35 patients across both home and clinic infusions. There was no difference in adherence (p = 0.71) and infection rates (p = 0.84) between home and clinic settings. Satisfaction with "convenience" of home infusions was significantly greater (p = 0.008) but there were no differences in quality of life measures. Excluding pharmacy, costs were A$74 lower per infusion at home, including A$16 of patients" out-of-pocket costs. INTERPRETATION: There were no differences in safety and effectiveness between clinic and home infusions of natalizumab. The home infusions were shown to be feasible, more convenient and less expensive than usual care. Larger scale studies are required to verify these preliminary findings, particularly around safety and management of hypersensitivity adverse events in the home setting and for equivalence of clinical outcomes.

Developing a Model of Care for Home Infusions of Natalizumab for People With Multiple Sclerosis.

Natalizumab is an effective treatment for multiple sclerosis that requires 4-weekly infusions that are usually provided in hospital outpatient clinics. In this study, a model of care (MOC), an overarching design for the provision of a health care service, was developed to permit home infusions of natalizumab. The proposed new MOC comprised 9 dimensions, in addition to the central concept of patient-centered care at home. The new MOC is responsive to patient needs and prioritizes the nurse-patient therapeutic relationship. It provides practical examples of patient-centered care to guide clinical practice for this patient population in the home setting.

Incidence of pregnancy and disease-modifying therapy exposure trends in women with multiple sclerosis: A contemporary cohort study.

BACKGROUND: Exposure to disease-modifying therapy (DMT) during early pregnancy in women with relapsing-remitting MS (RRMS) may be increasing. OBJECTIVE: To retrospectively determine incidence of pregnancy, DMT exposure and pregnancy outcomes in women with RRMS. METHODS: We identified all women with RRMS aged 15-45 years in the MSBase Registry between 2005-2016. Annualised pregnancy incidence rates were calculated using Poisson regression models. DMT exposures and pregnancy outcomes were assessed. RESULTS: Of 9,098 women meeting inclusion criteria, 1,178 (13%) women recorded 1,521 pregnancies. The annualised incidence rate of pregnancy was 0.042 (95% CI 0.040, 0.045). A total of 635 (42%) reported pregnancies were conceived on DMT, increasing from 27% in 2006 to 62% in 2016. The median duration of DMT exposure during pregnancy was 30 days (IQR: 9, 50). There were a higher number of induced abortions on FDA pregnancy class C/D drugs compared with pregnancy class B and no DMT (p = 0.010); but no differences in spontaneous abortions, term or preterm births. CONCLUSIONS: We report low pregnancy incidence rates, with increasing number of pregnancies conceived on DMT over the past 12-years. The median duration of DMT exposure in pregnancy was relatively short at one month.

Disability and HIV: What drives this relationship in Eastern and Southern Africa?

The Eastern and Southern Africa (ESA) region is the epicentre of the global HIV epidemic and also home to a large number of people with disabilities. Both HIV and Disability are significant public health issues. While they are generally viewed as distinct and unrelated phenomena data seems to suggest that they are particularly closely intertwined in ESA. For the first time in history, by using the same disability indicator consistently, the publication of the World Report on Disability in 2011 has allowed for the comparison of disability data between countries, and across regions. This has the potential to shed some light on the relationship between disability and socio-economic markers and other health conditions in a way that was not possible previously. In the absence of disability and HIV-specific population-based surveys, this paper uses global socio-economic and HIV datasets and compares them to data contained in the most recent World Report on Disability. The analysis suggests that disability prevalence may be related to HIV-prevalence in ESA (Pearson 0.87). It identifies research and policy gaps and seeks to shed light on the relationship between the two phenomena. It concludes that, more than any other region in the world, ESA needs to ensure better data collection on disability and the inclusion of disability throughout its HIV programmes in order to provide a comprehensive and appropriate response to the epidemic.

Patterns of disclosure and antiretroviral treatment adherence in a South African mining workplace programme and implications for HIV prevention.

Social and psychological barriers to the disclosure of one's seropositive HIV status to significant others and poor adherence to taking medications pose significant challenges to the scaling-up of access to antiretroviral treatment (ART) in the workplace. Such barriers are predictive of sub-optimal treatment outcomes and bedevil HIV-prevention interventions at a societal level. Against this background, this article explores the lived experiences of 19 HIV-positive male participants, between the ages of 33 and 57 years, who were enrolled in an ART programme managed at an occupational health clinic at a mining company in South Africa. The majority of these mineworkers had been aware of their HIV status for between 5 and 7 years. The study explored psychological and relational factors, as aspects of these participants lived experiences, which had a bearing on their adherence to their ART regimen and the disclosure choices that they made regarding their HIV status. In our sample, those participants who were adherent demonstrated higher levels of control and acceptance of their HIV infection and were more confident in their ability to manage their treatment, while the group who were non-adherent presented with lower levels of adherence motivation and self-efficacy, difficulties in maintaining a healthy lifestyle and significant challenges in maintaining control over their lives. While most of the men favoured disclosing their HIV status to their partners for the sake of treatment support, they were less sure about disclosing to family members and non-family members, respectively, because of their need to protect these persons and due to their fear of being stigmatised. It was evident that treatment adherence choices and behaviours were impacted by psychological and relational factors, including disclosure decisions. We conclude with a bivariate model for understanding the adherence behaviours that influenced different patterns of ART adherence among the sample, and offer recommendations for HIV-prevention and treatment interventions in a mining workplace.