Real-World UK, Ireland Study Confirms Long-Term Efficacy of SB5 in Psoriasis

Patients with psoriasis who were administered SB5, Samsung Bioepis’ adalimumab biosimilar (Hadlima; adalimumab-bwd), showed good tolerance to the drug and low treatment discontinuation rates, demonstrating that the biosimilar is safe and effective for patients to receive long term, according to a study conducted in the UK and Ireland.¹

Psoriasis is a chronic immune-mediated inflammatory disease that impacts the skin, joints, and other organs that is estimated to affect over 60 million people of all ages worldwide. | Image credit: Dragana Gordic - stock.adobe.com

Psoriasis is a chronic immune-mediated inflammatory disease that impacts the skin, joints, and other organs that is estimated to affect over 60 million people of all ages worldwide.² Managing psoriasis requires long-term treatment, which can have a significant impact quality of life and pose a considerable social and economic burden.

Reference adalimumab (Humira) is a widely used biologic for moderate to severe chronic plaque psoriasis, but its high price limits patient access.¹ In 2023, 9 adalimumab biosimilars launched on the US market, including SB5, as cost-effective alternatives.³ In particular, SB5 was approved based on phase 3 study results showing its effectiveness in moderate to severe rheumatoid arthritis and a separate study confirming its interchangeability with Humira for plaque psoriasis.⁴

However, real-world data on the long-term use, effectiveness, and safety of adalimumab biosimilars in patients with psoriasis remain limited.¹ Additionally, biologic treatments can often lead to adverse effects (AEs) that contribute to therapy discontinuation.

Researchers analyzed data from the British Association of Dermatologists’ Biologic Interventions Register, a multicenter observational cohort tracking the long-term effectiveness and safety of biologics in patients with psoriasis across the UK and Ireland. Eligible participants were adults with mild to moderate to severe psoriasis, as determined by baseline absolute Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores.

The study included data on adult patients with mild (PASI or DLQI <10) or moderate to severe psoriasis (PASI and DLQI ≥10) who initiated SB5 treatment between June 2018 and August 2022. Baseline demographics, disease characteristics, treatment changes, and discontinuation rates were assessed.

Overall, 1195 patients with psoriasis treated with SB5 from June 1, 2018, to August 31, 2022, were enrolled in the study. The mean age was 45.7 years, and the mean body mass index (BMI) was 31.8 kg/m². The mean treatment duration was 25.2 months, with patients who discontinued treatment doing so after an average of 11.2 months. Treatment discontinuation rates at years 1, 2, 3, and 4, were 26.5%, 37.2%, 41.9%, and 43.3%, respectively. Of the patients who discontinued, 13.3% did so due to inefficacy, and 12.6% due to AEs. No significant predictors were found for SB5 persistence, as covariates like age, BMI, comorbidities, and previous treatments had no impact on discontinuation rates.

Real-world evidence on SB5’s long-term drug survival in over 1000 patients with psoriasis showed that 73.5% stayed on treatment after 1 year, and 56.7% continued after 4 years. The main reasons for discontinuation were inefficacy, AEs, and patient choice. Compared with other studies, SB5's persistence rates were in line with studies assessing reference adalimumab. Obesity was associated with a higher risk of discontinuation, which the authors theorized could be due to the impact obesity can have on inflammation and the pharmacokinetics of tumor necrosis factor agonists.⁵

Study limitations included the absence of a control group, geographic restrictions to the UK and Ireland, potential social influences on drug persistence, a small number of switching cases, and limited real-world effectiveness data.

The authors also warned about the study’s generalizability.

“Accordingly, appropriate caution should be taken when generalizing the results from this study to other populations, and different social settings on drug persistence such as familiarity and attitude toward biosimilars should be considered.

References

1. Girolomoni G, Feldman SR, Egeberg A, et al. Long-term real-world evidence of SB5 (adalimumab biosimilar) treatment in patients with moderate-to-severe psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR). J Dermatolog Treat. 2024;35(1):2434091. doi:10.1080/09546634.2024.2434091

2. Griffiths CEM, Armstrong AW, Gudjonsson JE, et al. Psoriasis. Lancet. 2021;397(10281):1301-1315. doi:10.1016/S0140-6736(20)32549-6.

3. Jeremias S. The age of adalimumab is upon us: how stakeholders can prepare. The Center for Biosimilars^®. June 28, 2024. Accessed January 29, 2025. https://www.centerforbiosimilars.com/view/the-age-of-adalimumab-is-upon-us-how-stakeholders-can-prepare

4. Jeremias S. First round of adalimumab biosimilar launches in July. The Center for Biosimilars. July 2, 2023. Accessed January 30, 2025. https://www.centerforbiosimilars.com/view/first-round-of-adalimumab-biosimilar-launches-in-july

5. Singh S, Facciorusso A, Singh AG, et al. Obesity and response to anti-tumor necrosis factor-alpha agents in patients with select immune-mediated inflammatory diseases: a systematic review and meta-analysis. PLoS One. 2018;13(5):e0195123. doi:10.1371/journal.pone.0195123