Tofacitinib Use in Adults with Chronic Inflammatory Disease During the Severe Acute Respiratory Syndrome Coronavirus 2 Pandemic: What Is Known So Far?

BACKGROUND: Concerns have been raised that the risk of severe acute respiratory syndrome coronavirus 2 infection, or more severe or critical coronavirus disease 2019 (COVID-19), may be higher in immunocompromised individuals receiving immunomodulatory therapies compared with immunocompetent individuals. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. To date, data on tofacitinib treatment during the COVID-19 pandemic are limited. OBJECTIVES: To summarize current understanding of the use of tofacitinib in adults during the COVID-19 pandemic, and discuss research questions that are yet to be addressed, to further inform the safe and effective use of tofacitinib in clinical practice. METHODS: We conducted a review of the literature (as of February 2021), to summarize the expert recommendations for the management of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis in the context of COVID-19, and to assess the current data regarding the use of tofacitinib in adult patients during the pandemic. RESULTS: Current recommendations for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis state that tofacitinib treatment should be continued during the pandemic, except in cases of positive or presumed severe acute respiratory syndrome coronavirus 2 infection. However, limited data are available; analyses of data from international rheumatology and gastroenterology registries have suggested that tofacitinib may not be associated with an increased risk of hospitalization or treatment switching in adults with COVID-19. CONCLUSIONS: Further assessment of tofacitinib use in patients with rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis will be required to elucidate and establish the benefit:risk profile of tofacitinib during the current COVID-19 pandemic.

Strategic leadership: the essential skills.

The more uncertain your environment, the greater the opportunity--if you have the leadership skills to capitalize on it. Research at the Wharton school and at the authors' consulting firm, involving more than 20,000 executives to date, has identified six skills that, when mastered and used in concert, allow leaders to think strategically and navigate the unknown effectively. They are the abilities to anticipate, challenge, interpret, decide, align, and learn. This article describes the six skills in detail and includes a self-assessment that will enable you to identify the ones that most need your attention. The authors have found that strength in one skill cannot easily compensate for a deficit in another. An adaptive strategic leader has learned to apply all six at once.

Designing a brief and simple intervention to help young people with type 1 diabetes to live well: Protocol for developing a novel intervention with participation from young people.

Young people living with type 1 diabetes (T1D) navigate daily complex diabetes related tasks as they take on increasing (and eventually full) responsibility for managing their condition, in addition to developing their lives as independent adults. Alongside the need for careful day-to-day diabetes management, the psychosocial burden and mental health impact and stigma are well recognised. Despite advances in psychological care, many young people with diabetes still experience a greater mental health burden than those without diabetes. This study aims to develop a brief and simple intervention for young people with T1D that will support their wellbeing day to day, as required, and grow their ability to live confidently with their condition that requires lifelong meticulous management. Insights gained in this participatory study will guide the development and focus of the intervention which may involve a toolkit containing self-guided resources or which could be a series of recommendations on how to design a healthcare service with a support network that is tailored to the needs of young people. This study will consist of qualitative research and collaboration with young people with T1D and their siblings, friends, and peers to co-create a testable intervention. In Part 1, research interviews will be conducted with young people (16-24 years old) with T1D and, where possible, their siblings/peers to understand the day-to-day challenges of type 1 and what a novel intervention should address. Thematic analysis of interviews will inform the generation of a prototype intervention to take into part two, focus group discussions. Focus groups with (i) young people with T1D and, separately (ii) carers (comprising parents, carers, teachers, specialist nurses). Collaborative principles will be used to review, redesign and evolve the intervention to meet user needs. A blend of narrative and thematic analysis will inform the findings and report. Insights from Parts 1 and 2 will shape a user-defined and formatively analysed brief and simple intervention and future study design ready for pilot testing. The aim of this part of the research is to maximise acceptability and usability of a testable intervention by the target population. To aim of the future intervention will be to demonstrate effectiveness in helping young adults to live well with T1D.

Characterising meaningful patient and public involvement in the pharmaceutical industry research setting: a retrospective quality assessment.

OBJECTIVES: Patient and public involvement (PPI) in clinical research has a well-established infrastructure in the UK, and while there has been good progress within pharmaceutical-industry-sponsored research, further improvements are still needed. This review aims to share learnings from quality assessments of historical PPI projects within Pfizer UK to inform future projects and drive PPI progress in the pharmaceutical industry. DESIGN AND SETTING: Internal assessments of Pfizer UK PPI projects were conducted to identify all relevant projects across the medicines development continuum between 2017 and 2021. Five sample projects were developed into case studies. OUTCOME MEASURE: Retrospective quality assessments were performed using the Patient Focused Medicines Development (PFMD) Patient Engagement Quality Guidance (PEQG) tool. Recommendations for improvement were developed. RESULTS: Retrospective case study analysis and quality framework assessment revealed benefits of PPI to both Pfizer UK and to external partners, as well as challenges and learnings to improve future practice. Recommendations for improvement based on these findings focused on processes and procedures for PPI, group dynamics and diversity for PPI activities, sharing of expertise, the importance of bidirectional and timely feedback, and the use of understandable language in materials. CONCLUSIONS: PPI in medicines development is impactful and beneficial but is still being optimised in the pharmaceutical industry. Using the PFMD PEQG tool to define gaps, share learnings and devise recommendations for improvement helps to ensure that PPI is genuine and empowering, rather than tokenistic. Ultimately, these recommendations should be acted on to further embed PPI as an integral part of medicines development and health research within the pharmaceutical industry. This article includes a plain language summary in the supplement.

Exploring the Quality of Communication Between Patients with Psoriatic Arthritis and Physicians: Results of a Global Online Survey.

INTRODUCTION: Effective communication between patients with psoriatic arthritis (PsA) and their physicians is important for optimizing treatment outcomes. We assessed the quality of patient-physician communication in terms of awareness and impact of PsA symptoms, their levels of satisfaction, and their perceptions of communications. METHODS: A global online survey was conducted by The Harris Poll in adult patients with PsA and physicians managing patients with PsA in eight countries. Participating physicians were either rheumatologists or dermatologists seeing ≥ 10 and ≥ 5 patients with PsA per month, respectively. Patient and physician groups were unmatched. Patient-physician communication was assessed with 35-60 questions regarding discussion topics during consultations, levels of satisfaction with communication, and specific communication issues. RESULTS: A total of 1286 patients with PsA (983 and 303 whose primary treating physician was a rheumatologist or dermatologist, respectively) and 1553 physicians (795 rheumatologists and 758 dermatologists) completed the survey. Regardless of whether they were primarily treated by a rheumatologist or dermatologist, most patients reported a social (84% and 81%, respectively) or work (81% and 80%, respectively) impact of PsA, and a major/moderate negative impact on their physical activity levels (79% and 74%, respectively) or emotional/mental wellbeing (69% and 68%, respectively). Physician responses were generally consistent with this; however, physicians often appeared to under-recognize the extent to which PsA affects patients. Most (≥ 85%) patients and physicians were very/somewhat satisfied with their patient-physician communication, and most (≥ 86%) patients were comfortable raising their concerns/fears with their physician. However, > 40% of patients were identified as being at risk of suboptimal communication. These patients were significantly less likely to report their PsA symptoms even when asked, were less comfortable discussing the impacts of PsA with their physician, and were more likely to experience major/moderate impacts of PsA on their health-related quality of life (HRQoL). CONCLUSIONS: Physicians often underestimate the impacts of PsA, compared with patients, and some patients may be at risk of suboptimal communication with their attending physician, which may worsen the HRQoL impacts of PsA. These findings highlight a need for ways to improve communication between patients with PsA and their healthcare providers.

Psoriatic arthritis (PsA) is a disease that can cause swollen and painful joints, as well as skin psoriasis. To effectively treat PsA, it is important that doctors and patients communicate well. We used a survey to ask patients with PsA and doctors from around the world about their communications about PsA. We also asked how PsA affects patients' quality of life. In total, 1286 patients and 1553 doctors took the survey. Most patients said that PsA affected their social and work lives. Similarly, PsA had a negative impact on physical activity and on emotional and/or mental wellbeing in most patients who answered the survey. Doctors answered similarly, but they were generally less likely to recognize how severely PsA can impact patients, compared with patients themselves. Most patients and doctors were happy with their patient­doctor communication, and most patients felt comfortable talking about their worries and/or fears with their doctor. However, some patients (about four out of 10) felt that communication with their doctors was not good; these patients were less likely/comfortable to talk about their PsA symptoms and the impacts of PsA with their doctor. PsA was also more likely to negatively impact these patients' quality of life. This survey shows that it is important to find ways to improve communication between patients with PsA and their doctors.

Looking through the patient lens - Improving best practice for young people with juvenile idiopathic arthritis transitioning into adult care.

We describe a qualitative study to establish the emerging needs of young people with juvenile idiopathic arthritis (JIA) as they go through the transition process, identifying which elements are valued and where support gaps exist. Qualitative interviews with healthcare professionals, young people with JIA and their parents explored the lived experience of transition to care in an adult rheumatology clinic. Perspectives of the experience and reflections of the process of transitioning were captured along with the young people's views of optimal support. Service provision in the clinical environment varied. Service design for this particular patient group has an impact on how young people optimise management of, and engagement with, their condition during young adulthood. Two specific themes emerged that had the greatest impact on defining a positive user experience of transitioning care: tailored service provision within the clinical environment and support for those living with JIA beyond the clinic doors (we have termed these the lived experience). Factors of importance to young people with JIA were grouped into key domains, namely: day-to-day life with JIA, emotional and developmental factors and a desire for independence. The young people and healthcare professionals interviewed in this small qualitative study highlighted some common themes considered critical in the development and organisation of an excellent care pathway from paediatric to adult healthcare. Aligning the clinical process with young people's individual needs and lifestyle creates stronger beginnings in adult care.