Making Information About Cladribine Tablets Accessible to People with Multiple Sclerosis: A Patient-Survey-Led Narrative Review for Healthcare Professionals.

Cladribine tablets have been granted marketing authorization in Europe and approved by the Food and Drug Administration (FDA) in the USA to treat relapsing forms of multiple sclerosis (MS). However, people with MS (PwMS) may be more familiar, and therefore more confident, with treatments requiring long-term and frequent dosing. Differences in such treatment strategies can lead to questions relating to how short-course non-continuous treatments, such as cladribine tablets, can work and how well they are tolerated. In response to this, we aimed to create an evidence-based report on patient-focused aspects of treatment with cladribine. To inform development, MS experts, including healthcare professionals (HCPs) and PwMS, proposed topics that PwMS and their families and caregivers would most like to discuss with HCPs during consultations to help them better understand cladribine treatment. The statements regarding each topic were then ranked by PwMS and used to inform the topics covered in this report. We explain here the use of cladribine tablets, which includes explanations of how cladribine tablets work, how to take cladribine tablets, and considerations required prior to and while taking cladribine tablets. We also describe how cladribine tablets affect relapse rate and quality of life and detail side effects, when they are likely to happen, and for how long. We also discuss how cladribine tablets affect family planning, fertility, and the use of vaccines. Alongside each section is a brief, plain language description of what is covered and an accompanying visual to aid conversations between HCPs and PwMS. Improved understanding by PwMS of treatments, such as cladribine, can empower them to play a bigger role in shared decision-making regarding their treatment. Additionally, the open dialogue we aim to promote with this type of report could lead to treatment choices being better tailored for individuals with chronic diseases on the basis of personal experiences, preferences, and circumstances.

Quantifying the administration and monitoring time burden of several disease-modifying therapies for relapsing multiple sclerosis in the United Kingdom: A time and motion study.

BACKGROUND: The treatment landscape for relapsing multiple sclerosis (MS) has changed dramatically in recent decades, including an increasing number of high-efficacy disease-modifying therapies (DMTs) with varied administration and monitoring requirements. Coupled with greater focus on earlier treatment, these factors have resulted in stretching of the capacity of MS specialist services and allied healthcare professionals (HCPs). To assist with the effective planning of MS services in the UK NHS, this study quantified the administration and monitoring time burden associated with high-efficacy DMTs (alemtuzumab, cladribine tablets, fingolimod, natalizumab, and ocrelizumab) for relapsing MS. METHODS: A Time and Motion (T&M) study was conducted across four MS centres in the UK, over 3-4 months per centre (Aug 2019-Feb 2021). Time dedicated by HCPs (including but not limited to neurologists, MS specialist nurses, infusion nurses, and healthcare assistants) to pre-specified drug administration and monitoring activities, elicited during pre-study interviews at each centre, was assessed for each of the selected DMTs. Administration activities included: installing peripheral access; pre-medication administration (if needed); preparing drug for infusion; infusion initiation, monitoring, and disconnection; and patient monitoring post-infusion. Monitoring activities included: booking appointments for blood draws; blood draw; retrieval and review of blood results; maintaining blood records and follow-up with the patient; checking availability of MRI results and follow-up with the patient; booking appointments for neurologist or nurse consultations; and checking patient files prior to clinic visits. A T&M model was built using observational T&M study results, data obtained through pre-study interviews, as well as stipulated monitoring intervals from relevant Summaries of Product Characteristics for the selected DMTs, to estimate active HCP time with each DMT, extrapolated over a period of 4 years per-patient. RESULTS: For oral DMTs, projected total active HCP time (monitoring only) per-patient over 4 years was 14.7 h for cladribine tablets and 19.2 h for fingolimod. For infused DMTs, total time (administration and monitoring) for alemtuzumab was 37.7 h (6.0 and 31.6 h, respectively), 48.1 h for natalizumab (17.4 and 30.8 h, respectively), and 23.5 h for ocrelizumab (6.1 and 17.4 h, respectively). CONCLUSIONS: While active HCP time varied across centres, infused DMTs were projected to require the greatest amount of HCP time associated with administration and monitoring over 4 years versus oral DMTs. These findings may assist MS-specific HCPs in planning and delivering the equitable provision of DMT services for patients with relapsing MS.

Tolerability of subcutaneous ofatumumab with long-term exposure in relapsing multiple sclerosis.

Background: Ofatumumab is approved for treating relapsing multiple sclerosis (RMS). Examining tolerability will enable understanding of its risk-benefit profile. Objective: Report the tolerability profile of ofatumumab in RMS during treatment of up to 4 years and the effect of pre-medication. Methods: Cumulative data from the overall safety population included patients taking continuous ofatumumab or being newly switched from teriflunomide. Injection-related reactions (IRRs) by incidence and severity, and post-marketing surveillance data, with an exposure of 18,530 patient-years, were analyzed. Results: Systemic IRRs affected 24.7% of patients (487/1969) in the overall safety population; most (99.2% [483/487]) were mild (333/487) to moderate (150/487) in Common Terminology Criteria for Adverse Events severity; most systemic IRRs occurred after first injection. Local-site IRRs affected 11.8% (233/1969) and most (99.6% [232/233]) were mild/moderate. Incidence and severity of systemic and localized IRRs were similar between continuous and newly switched patients across repeated injections. Systemic IRR incidence and severity were not substantially affected by steroidal or non-steroidal pre-medication. Post-marketing surveillance identified no new tolerability issues. Conclusion: Ofatumumab is well tolerated, displays a consistent safety profile during continuous use or after switching from teriflunomide and does not require pre-medication. This enables home management of RMS with a high-efficacy treatment.

Patient and nurse preference for Sensoready autoinjector pen versus other autoinjectors in multiple sclerosis: results from a pilot multicenter survey.

BACKGROUND: Sensoready® autoinjector pen facilitates self-administration of subcutaneous ofatumumab injections at home. We aim to investigate patient and nurse preference for using Sensoready® versus comparator autoinjectors in multiple sclerosis (MS). METHODS: A pilot survey was conducted in Germany followed by in-field interviews across United States, Germany, France, and Italy. The survey recruited 80 MS patients and 50 MS nurses. Respondents were interviewed for 45-min on qualitative open-ended and quantitative close-ended survey consisting of 31 questions for patients and 41 for nurses. Ratings were measured on Likert scale from 1 (not at all important) to 10 (extremely important). RESULTS: "Easy to perform self-injection with the pen" and "Patient able to use independently" (both, mean overall score 9.4) were the most important attributes for both patients and nurses. Sensoready® scored high across most important attributes for both patients and nurses (p < 0.05). Sensoready® was preferred over comparator devices across majority of the important attributes (84%; p < 0.05), especially ease of use of the pen (mean overall score 9.4). Sensoready® was preferred over their current device by 9/10 nurses and 8/10 patients if they had to choose a treatment based on the device alone. CONCLUSION: Both MS patients and nurses preferred the Sensoready® (ofatumumab) over comparator autoinjectors for their treatment, mostly driven by ease of administration.

The prevention and management of hospital admissions for urinary tract infection in patients with multiple sclerosis.

INTRODUCTION: Urinary tract infections (UTIs) are one of the commonest reasons for patients with multiple sclerosis (PwMS) presenting to hospital. Management of recurrent UTIs in PwMS can be challenging and characteristics of such patients are not well described. AIMS: To describe the neurological and urological features of PwMS presenting to hospital for UTIs and identify areas of management that could be improved to reduce UTI frequency. METHODS: Health episode statistics data were used to identify PwMS presenting to a tertiary hospital with UTI over a 5-year period. Medical records were reviewed for demographic, MS and urological history. The seven PwMS with the highest numbers of encounters were seen in a multidisciplinary clinic to enable detailed assessments. RESULTS: 52 PwMS (25 female, 27 male) with mean age of 60 had 112 emergency department presentations and 102 inpatient admissions for UTI. 24 presented multiple times and were more likely to be older and male with progressive MS. Almost two-thirds were using a urinary catheter. Less than half were under current urological and neurological follow-up. Escherichia coli and Pseudomonas spp were the commonest organisms cultured. Resistance to antibiotics was more frequent in patients with multiple presentations. CONCLUSIONS: PwMS presenting to hospital for UTIs are more often male, older, with progressive MS and high levels of disability. A small group of PwMS accounted for a large number of encounters. Preventative and management strategies can be applied in primary and secondary care settings, with an emphasis on bladder, catheter and general physical care.