Objectives We aimed to evaluate the use of an eHealth platform and a self-management outpatient clinic in patients with rheumatoid arthritis (RA) in a real-world setting. The effect on healthcare utilization and disease activity were studied. Methods Using hospital data of patients with RA between 2014 and 2019, the use of an eHealth platform and participation in a self-management outpatient clinic were studied. An interrupted time series analysis compared the period before and after the introduction of the eHealth platform. The change in trend (relative to the pre-interruption trend) for the number of outpatient clinic visits and the disease activity score 28-joints (DAS28) was determined for several scenarios. Results After the platform’s implementation in April 2017, the percentage of patients using it was stable around 37%. On average, the users of the platform were younger, more highly educated and had better health outcomes than the total RA population. After the implementation of the platform, the mean number of quarterly outpatient clinic visits per patient decreased by 0.027 per quarter (CI = [-0.045;-0.08], p-value = 0.007). This was accompanied by a significant decrease in DAS28 of 0.056 per quarter (CI = [-0.086;-0025], p-value = 0.001). On average this resulted in 0.955 less visits per patient per year and a 0.503 reduction in the DAS28 Conclusions The implementation of remote patient monitoring has a positive effect on healthcare utilization, while maintaining low disease activity. This should encourage the use of this type telemedicine in the management of RA, especially, when many routine outpatient clinic visits are cancelled due to COVID-19.

Objective Study the effect of non-mandatory transitioning from etanercept originator to etanercept biosimilar on retention rates in a shared decision making-promoting setting. Methods In 2016 all patients treated with etanercept originator and stable disease at the Rheumatology department in Bernhoven were offered transitioning to etanercept biosimilar by opt-in approach. A historical cohort of patients treated with etanercept originator in 2015 was identified as control group. Etanercept discontinuation was compared between the cohorts using Cox-regression. To study the nocebo-effect reasons for discontinuation were categorized into objective reasons (e.g., laboratory abnormalities, increase in swollen joint count, allergic reaction) and "subjective health complaints" (symptoms only perceptible to the patient, e.g., tiredness, arthralgia). An adjusted Kaplan-Meier curve for retention of the etanercept biosimilar was made, censoring subjective health complaints as reason for discontinuation. Results 70 of the 79 patients eligible for transitioning agreed to transition (89%). The one year crude retention rate of etanercept in the transition cohort was 73% (95% CI 0.62-0.83), compared to a retention rate of 89% (95% CI 0.81-0.95) in the historical cohort, p-value= 0.013. This resulted in a higher risk of treatment discontinuation in the transition cohort (adjusted hazard ratio=2.73; 95%CI 1.23-6.05, p-value= 0.01). After adjusting for the nocebo-effect, the cohorts had comparable retention rates (86% vs. 89%, p-value= 0.51). Conclusion Non-mandatory transition from etanercept originator to its biosimilar using an opt-in approach in a shared decision-making promoting setting resulted in a higher discontinuation of etanercept compared to the historical cohort. This could largely be attributed to the nocebo-effect.

Objective The market entry of biosimilars is expected to bring budgetary relief. Our objective was to determine how the introduction of biosimilars influences medication cost in patients with rheumatoid arthritis and which patients gain access to biologicals due to the availability of biosimilars. Methods Using hospital data of patients with rheumatoid arthritis between 2014 and 2018, an interrupted time series was performed. The interruption in the time series was placed at June 2016, i.e., the introduction of the etanercept biosimilar. The changes in trends for rheumatic medication cost before and after the interruption were measured. Secondary analyses focused on explaining these trends. Results In the first quarter after the interruption, there was a decrease in total cost for biologic users of €-63020 (CI=[€-96487;-€-29553]; P=0.001). The post-interruption trend did not differ from the pre-interruption trend (CI=[-€6695;€6715]; P=0.998) and after three quarters the medication cost were back at the interruption level. After the interruption, the average cost per biologic user decreased by €-370 (CI=[€-602;€-138]; P=0.005), followed by a quarterly decrease (relative to the pre-interruption trend) (CI=[€-86;€-14] P=0.010), bending the average cost curve. The percentage of patients being treated with biologics increased in post-interruption by 0.50 percentage points quarterly (CI=[0.38-0.62]; P<0.001). Also the average age at the start of the first biologic increased after the interruption (p=0.057). Conclusion The average cost per patient treated with biologicals decreased after the introduction of biosimilars with a persistent trend. However, the budgetary relief due to market entry of biosimilars vanished quickly due to an increase in patients treated with biologics.

BackgroundWith biological patents expiring, biosimilars are becoming a realistic, less costly alternative to their originator. The data from numerous randomised clinical trials support that it is safe, effective and cost saving to switch to a biosimilar. However, real world data about efficacy, safety, and cost-effectiveness of such a switch are lacking.Since shared decision making (SDM) is a key factor in the treatment of rheumatic diseases, a non-mandatory open label transitioning from Etanercept originator to its biosimilar was performed at the rheumatology department of Bernhoven.ObjectivesThe first goal of this study was to investigate the effect of switching from Etanercept originator to its biosimilar on the effectiveness of treatment. The second aim was to analyse the effect of SDM on the 1 year retention rates and reasons for withdrawal in daily clinical practice.MethodsAll patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) that were using Etanercept originator between 01–06–2016 and 23–10–2017 were informed by letter of the possibility to switch to its biosimilar. During the next outpatient visit with their rheumatologist the possibility to switch was discussed. Patients had the opportunity to ask questions regarding biosimilars and the switch to a biosimilar. If patients agreed the switch was made, with the reservation that they could switch back to the originator if they encountered difficulties with the biosimilar.Using the registry of the rheumatology department at Bernhoven data were collected on disease activity (DA), medication use and adverse events from the moment of switch till 23–10–2017. As measure for DA the DAS28 was used for RA and PsA, the ASDAS was used for SpA. Stop reasons for biosimilars were verified using the health record system of the hospital. Reasons for change in disease activity and discontinuation of biosimilar treatment were assessed.ResultsBetween 01–06–2016 and 23–10%–2017 80% (69 patients) of the Etanercept originator users switched to its biosimilar. These patients switched to biosimilar after a median time of 5.1 (IQR 2.8–8.3) years. By 23–10–2017, median follow-up of 307 (IQR 196–357) days, the mean DA did not significantly differ from the DA at baseline, 3.1 (95%>CI 2.5–3.7) vs. 2.8 (95%>CI 2.5–3.1). At end of follow-up 25% of the patients had discontinued there treatment and either switched back to originator (18%), switched to another biological (3%) or stopped treatment with biologicals (4%).Reasons for switching back to originator were adverse events (58%), lack of effect (17%) and “adverse event and lack of effect” (25%). Only one serious adverse event was reported. This was a drug hypersensitivity reaction. After the patient was recovered, the originator was restarted without any difficulties.ConclusionsAn open label non-mandatory switch from Etanercept originator to its biosimilar showed that around 80% of the patients is willing to perform this switch. Switching did not affect effectiveness of treatment during ...