INTRODUCTION
Psoriasis is a chronic, systemic, inflammatory skin disease with a risk of comorbidities and a potential high impact on patients’ quality of life. The introduction of biologic therapies has improved the management of psoriasis, but the high cost limits access to these medications. A biosimilar is a biological product that is highly similar to a reference product, for which there are no clinically meaningful differences from a reference product in terms of safety, purity and potency.1,2 Although regulatory approval pathways for biosimilars is abbreviated, the development of biosimilars requires extensive scientific analyses and stringent manufacturing processes.3 Biosimilars can lower treatment costs, thereby increasing patient access, which may lead to better overall outcomes.4
SB4 is an approved biosimilar of the reference etancercept in EU.5 Compared to other indications, such as rheumatological disorders or inflammatory bowel disease, there are few published real world experiences with biosimilars in psoriasis, and most of them are limited to short-term data.6,7 Here, we report clinical outcomes of SB4 in psoriasis patients enrolled in BADBIR, a prospective observational register of patients with psoriasis in the UK and Republic of Ireland.8 There is a strong uptake of biosimilars in the UK and uptake of etanercept biosimilars is reaching up to 86%.9 With the availability of biosimilars, clinical experience with biosimilar use may provide additional assurance that biosimilar is as effective and safe as the reference product.
SB4 is an approved biosimilar of the reference etancercept in EU.5 Compared to other indications, such as rheumatological disorders or inflammatory bowel disease, there are few published real world experiences with biosimilars in psoriasis, and most of them are limited to short-term data.6,7 Here, we report clinical outcomes of SB4 in psoriasis patients enrolled in BADBIR, a prospective observational register of patients with psoriasis in the UK and Republic of Ireland.8 There is a strong uptake of biosimilars in the UK and uptake of etanercept biosimilars is reaching up to 86%.9 With the availability of biosimilars, clinical experience with biosimilar use may provide additional assurance that biosimilar is as effective and safe as the reference product.
MATERIALS AND METHODS
Data of patients recorded in BADBIR and treated with SB4 from Jan 01, 2016 were transferred. Data cut off date was Sep 01, 2018. Transferred data included patient demographics, disease characteristics at registry enrollment, change in therapy and measurement of effectiveness.
Discontinuation of therapy was defined as any gap in treatment for more than 90 days and patients had recorded as discontinuation during the follow-up were regarded as discontinued. The discontinuation data were assessed with Kaplan Meier analysis. Baseline Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) were based on the highest PASI and DLQI recorded within 183 days prior to a specific time point. PASI and DLQI at 6 months represents PASI and DLQI score recorded between 4--8 months (12--243 days). Efficacy assessment was conducted based on patients who had PASI and DLQI score both at baseline and at 6 months.
Discontinuation of therapy was defined as any gap in treatment for more than 90 days and patients had recorded as discontinuation during the follow-up were regarded as discontinued. The discontinuation data were assessed with Kaplan Meier analysis. Baseline Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) were based on the highest PASI and DLQI recorded within 183 days prior to a specific time point. PASI and DLQI at 6 months represents PASI and DLQI score recorded between 4--8 months (12--243 days). Efficacy assessment was conducted based on patients who had PASI and DLQI score both at baseline and at 6 months.
RESULTS
Clinical data on 189 patients who were newly registered to BADBIR were available for analysis. Baseline enrollment characteristics were: Mean age was 47.3±13.1 year, 56.1% were male, and mean body mass index (BMI) was 30.7±6.7 kg/m2. 18.5% of patients had psoriatic arthritis. The mean disease duration was 22.6±13.5 years, and baseline PASI and DLQI were 11.6±7.3 and 13.1±8.9, respectively.
At the initation of SB4, 16 patients (8.5%) were previously exposed to biologic (13, reference etanercept; 3, adalimumab; 1, infliximab biosimilar; 1, secukinumab; 1, ustekinumab). Among these, 10 patients were transitioned from reference etanercept to SB4. The reasons for this transition were: financial consideration (8), inefficacy (1), and other (1).
Median treatment period for SB4 was 14.1 months (IQR, 7.6--20.1 months). There were 50 discontinuations out of 190 treatment sequences, 24.4% at 12 months and 29.3% at 24 months analyzed by Kaplan Meier method (Figure 1). Most discontinuation of SB4 occurred within 12 months and median time to discontinue SB4 from the start was 5.4 months (IQR, 3.5--9.1 months). Reasons for discontinuation included lack of effectiveness (30), adverse events (8), patient choice (3), patient non-compliance (2), contradiction (1), death (1), lack of effectiveness and adverse events (1), and others (4). Among the 10 patients who
At the initation of SB4, 16 patients (8.5%) were previously exposed to biologic (13, reference etanercept; 3, adalimumab; 1, infliximab biosimilar; 1, secukinumab; 1, ustekinumab). Among these, 10 patients were transitioned from reference etanercept to SB4. The reasons for this transition were: financial consideration (8), inefficacy (1), and other (1).
Median treatment period for SB4 was 14.1 months (IQR, 7.6--20.1 months). There were 50 discontinuations out of 190 treatment sequences, 24.4% at 12 months and 29.3% at 24 months analyzed by Kaplan Meier method (Figure 1). Most discontinuation of SB4 occurred within 12 months and median time to discontinue SB4 from the start was 5.4 months (IQR, 3.5--9.1 months). Reasons for discontinuation included lack of effectiveness (30), adverse events (8), patient choice (3), patient non-compliance (2), contradiction (1), death (1), lack of effectiveness and adverse events (1), and others (4). Among the 10 patients who
