Rheumatology Patients' Experiences of a Mandatory Nationwide Transition to an Adalimumab Biosimilar.

OBJECTIVE: Transitions to biosimilars are common to reduce the cost burden of biologics. While brand changes can be daunting for patients, few studies have explored patients' experiences with the transitioning process. This study examined rheumatology patients' experiences with a mandatory nationwide brand change to an adalimumab biosimilar. METHODS: People with rheumatic diseases involved in the adalimumab transition in Aotearoa New Zealand completed a nationwide online survey. Participants (n = 117, 48% with rheumatoid arthritis) reported their satisfaction with the biosimilar, logistics and supply, information and communication, and availability of support. They also reported what did and did not go well during the transition and provided recommendations for future transitions. RESULTS: The mean [SD] satisfaction score with the transition was 6.2 [3.2] on a 0-10 scale, with 10 indicating high satisfaction. Participants were the least satisfied with the support and information from patient support organizations, and training for the device during the transition. Participants were most satisfied with the biosimilar supply, support from pharmacists, and how early they were informed before the transition occurred. After the transition, participants were less satisfied with the device quality, patient support program, biosimilar safety and efficacy, and the provision of alcohol wipes and sharps bins (p < 0.05 for all). Satisfaction with training for the biosimilar device (B = .25, p = .036) predicted overall satisfaction. Participants appreciated less injection pain and the ease of the biosimilar device. The lack of alcohol wipes and loss of the bio-originator support program were viewed negatively. CONCLUSION: Future biosimilar transitions should ensure the availability of alcohol wipes, sharps bins, and a comparable patient support program. Patient support organizations could be involved in providing information to patients about the change.

Health Care Providers' Experiences of a Mandatory Nationwide Transition to an Adalimumab Biosimilar.

OBJECTIVE: Transitioning patients to biosimilars has become common to reduce costs and improve access. However, it is unclear how the transition process impacts health care providers at the frontline of the brand change. This study explores health care providers' experiences of a mandatory brand change to an adalimumab biosimilar. METHODS: A cross-sectional study was conducted in Aotearoa New Zealand with 164 providers involved in the nationwide adalimumab brand change. Rheumatologists (n = 39), rheumatology nurses (n = 16), and pharmacists (n = 109) completed a survey that assessed their satisfaction with logistics and supply, information and education, support, and administrative workload and reported what did and did not go well during the transition. RESULTS: The mean satisfaction score (0-10) with the transition was 5.7 (SD = 2.6). Providers were the least satisfied with training for the biosimilar device, information from government agencies, and administrative workload during the transition. Satisfaction with adalimumab safety, efficacy and device quality, and the availability of sharps bins, alcohol wipes, and patient support was lower following the transition. Satisfaction with administrative workload (B = 0.37, P < 0.001) and training for the device (B = 0.20, P = 0.020) predicted overall satisfaction. Providers reported that a poorly implemented initial authorization process, loss of a patient support program, and insufficient communication between providers complicated the transition. The citrate-free preservative and longer authorization duration after the transition were viewed positively. CONCLUSION: Providers experienced an increased workload and reported less satisfaction with the biosimilar following the transition. Experiences may be improved by ensuring training for the device, a high-quality patient support program, and functioning authorization processes throughout the transition.

Impact of Television Depictions of Gout on Perceptions of Illness: A Randomized Controlled Trial.

OBJECTIVE: Gout is a chronic disease that can be effectively managed with long-term urate-lowering therapy. However, it is frequently portrayed on screen as an acute disease caused by a poor diet that should be managed with lifestyle changes. This study was undertaken to investigate the impact of a fictional television depiction of gout on perceptions of the disease and its management. METHODS: In a randomized controlled single-blind study, 200 members of the public watched either a 19-minute commercial television comedy episode that depicted gout as an acute disease caused by poor diet and managed with lifestyle changes, or a control episode from the same television series that did not mention gout or other diseases. Participants completed a survey regarding their perceptions of gout, its likely causes, and management strategies. RESULTS: Participants randomized to watch the gout-related episode believed gout had greater consequences (mean score of 7.1 versus 6.2 on an 11-point Likert scale; P < 0.001) and were more likely to rank the most important cause as poor eating habits compared to the control group (70% versus 38%; P < 0.001). They were also less likely to believe it is caused by genetic factors or chance. Participants watching the gout-related episode believed a change in diet would be a more effective management strategy (9.0 versus 8.4; P = 0.004) and long-term medication use would be less effective (6.9 versus 7.6; P = 0.007) compared to participants in the control group. CONCLUSION: Television depictions of gout can perpetuate inaccurate beliefs regarding causes of the disease and underemphasize effective medical strategies required in chronic disease management.

Effect of a Three-Day Course of Dexamethasone on Acute Phase Response Following Treatment With Zoledronate: A Randomized Controlled Trial.

Zoledronate is a potent intravenous bisphosphonate effective in the management of osteoporosis, Paget's disease and skeletal-related events in malignancy. Its most frequent adverse effect is the acute phase response (APR), an inflammatory reaction characterized by fever, musculoskeletal pain, headache, and nausea. This randomized, placebo-controlled, double-blind study investigated the efficacy of a three-day course of dexamethasone 4 mg daily in reducing incidence of APR. Participants (n = 60) were randomized to receive either 4 mg of oral dexamethasone 1.5 hours before zoledronate and once a day for the following 2 days, or placebo. Oral temperature was measured at baseline and three times a day for the following 3 days, and questionnaires assessing symptoms of the APR were completed at baseline and for 3 days following zoledronate. Use of anti-inflammatory medication in the 3 days following zoledronate was recorded. The primary outcome was the temperature change from baseline. There was a significant difference in the primary outcome between the dexamethasone and placebo groups (p < 0.0001), with a mean decrease in temperature of 0.10°C (95% confidence interval [CI], -0.34 to 0.14) in the dexamethasone group compared with a mean increase in temperature of 0.84°C (95% CI, 0.53-1.16) in the placebo group on the evening following zoledronate. There was also a difference in APR-related symptom score over time between the two groups (p = 0.0005), with a median change in symptom score in the dexamethasone group 1 day after zoledronate of 0 (95% CI, 0-1) compared with 3 (95% CI, 0-5) in the placebo group. An increase in temperature of ≥1°C to a temperature of >37.5°C occurred in two of 30 (6.7%) participants in the dexamethasone group compared with 14 of 30 participants (46.7%) in the placebo group (p = 0.0005). This study demonstrates that a 3-day course of dexamethasone substantially reduces the APR following zoledronate infusion. © 2023 American Society for Bone and Mineral Research (ASBMR).

Quality of care in people requiring hospital admission for gout in Aotearoa New Zealand: a nationwide analysis.

BACKGROUND: The quality of care for patients admitted with a primary diagnosis of gout, both before and after admission, has not been systematically examined. AIMS: To understand national trends in hospital admission for a primary diagnosis of gout in Aotearoa New Zealand over the past 10 years and the quality of care for gout received by these patients before and after the admission. METHODS: Data from the Aotearoa New Zealand National Collections from 1 January 2007 to 31 December 2019 were analysed to determine rates of hospital admission for a primary diagnosis of gout. Admission data include cost-weight analysis, as well as quality of care data including gout-specific medication dispensing in the year prior and year after admission. RESULTS: There were 13 721 admissions with a primary diagnosis of gout over the analysis period, with an average cost per admission in 2019 of NZ$4301. The rate of admission per 100 000 population was highest in Pacific peoples followed by Maori. Although dispensing of any allopurinol increased in the year after admission, rates of regular allopurinol dispensing remained low; 38.1% for admissions in 2018. Patients who were younger (especially 20-44 years), not enrolled in a primary health organisation before admission and female had lower rate of regular allopurinol after admission. CONCLUSION: In this nationwide study, rates of admission for gout were highest in Pacific peoples and in Maori. Rates of regular allopurinol dispensing were low even after admission for a primary diagnosis of gout. These findings highlight the need for improvements in gout management in Aotearoa New Zealand, including in post-discharge planning from secondary care inpatient services.

Intensive Serum Urate Lowering With Oral Urate-Lowering Therapy for Erosive Gout: A Randomized Double-Blind Controlled Trial.

OBJECTIVE: To determine whether a therapeutic approach of intensive serum urate lowering results in improved bone erosion scores in patients with erosive gout. METHODS: We undertook a 2-year, double-blind randomized controlled trial of 104 participants with erosive gout who were receiving serum urate-lowering therapy orally and who had serum urate levels of ≥0.30 mmoles/liter at baseline. Participants were randomly assigned to either an intensive serum urate target of <0.20 mmoles/liter or a standard target of <0.30 mmoles/liter (considered the standard according to rheumatology guidelines). Oral serum urate-lowering therapy was titrated to target using a standardized protocol (with the maximum approved doses of allopurinol, probenecid, febuxostat, and benzbromarone). The primary end point was the total computed tomography (CT) bone erosion score. Outcome Measures in Rheumatology (OMERACT) gout core outcome domains were secondary end points. RESULTS: Although the serum urate levels were significantly lower in the intensive target group compared to the standard target group over the study period (P = 0.002), fewer participants in the intensive target group achieved the randomized serum urate target level by year 2 (62% versus 83% of patients in the standard target group; P < 0.05). The intensive target group required higher doses of allopurinol (mean ± SD 746 ± 210 mg/day versus 497 ± 186 mg/day; P < 0.001) and received more combination therapy (P = 0.0004) compared to the standard target group. We observed small increases in CT bone erosion scores in both serum urate target groups over 2 years, with no between-group difference (P = 0.20). OMERACT core outcome domains (gout flares, tophi, pain, patient's global assessment of disease activity, health-related quality of life, and activity limitation) improved in both groups over 2 years, with no between-group differences. Adverse event and serious adverse event rates were similar between the groups. CONCLUSION: Compared to a serum urate target of <0.30 mmoles/liter, more intensive serum urate lowering is difficult to achieve with an oral urate-lowering therapy. Intensive serum urate lowering leads to a high medication burden and does not improve bone erosion scores in patients with erosive gout.

Gout, Hyperuricaemia and Crystal-Associated Disease Network (G-CAN) common language definition of gout.

OBJECTIVE: To develop a Gout, Hyperuricaemia and Crystal-Associated Disease Network (G-CAN) common language definition of gout, with the goal of increasing public understanding and awareness, and ensure consistent and understandable messages about gout. METHODS: A G-CAN working group that included patients, physicians and nongovernmental organisation (NGO) representatives was formed to develop a common language definition of gout for use with the public, media, healthcare providers and stakeholders. A literature search and interviews with patients, healthcare workers and stakeholders informed development of the definition. Following consultation with G-CAN members and partners, the definition was endorsed by the G-CAN board. RESULTS: The G-CAN common language definition of gout describes the epidemiology, pathophysiology, symptoms and impact, risk factors, comorbidities, management and healthcare and workforce considerations. Detailed information is provided to support the content of the definition. After the publication of the English-language version, the definition will be available for translation into other languages by G-CAN members. CONCLUSION: G-CAN has developed a concise and easily understandable statement describing gout in language that can be used in conversations with the lay public, media, NGOs, funders, healthcare providers and other stakeholders.

"An apple pie a day does not keep the doctor away": Fictional depictions of gout in contemporary film and television.

BACKGROUND: Fictional portrayals of illness and medical management in film and television can reflect and perpetuate cultural stereotypes about illness. The aim of this study was to analyse fictional depictions of gout in contemporary film and television. METHODS: We conducted a search for English language depictions of gout in film and television since 1990 using the Internet Movie Database (IMDb), other internet media databases, and member suggestions from the Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN). Film and television episodes with gout content were analysed for depictions of characters with gout, causal factors, and management strategies (n=44). RESULTS: Gout was used to denote royalty or nobility in historical settings, and as a plot device to explain the absence of characters from key events. The most commonly depicted causes of gout were overindulgence of food and alcohol (61%), and portrayals of biological causes were infrequent (12%). Common management strategies were change in diet (36%) and short-term pain relief (32%), with only one mention of urate-lowering therapy (5%). The majority of films and television episodes depicted gout as humorous (59%) and embarrassing (50%). CONCLUSIONS: In contemporary film and television, gout is portrayed as a humorous and embarrassing condition, caused by dietary indulgence. These depictions may reinforce inaccurate beliefs about the causes of gout and its management.