SB5 is Effective and Safe for Long-Term Psoriasis Treatment

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SB5 (adalimumab-bwwd, Hadlima) an FDA-approved adalimumab biosimilar that targets tumor necrosis factor (TNF), was found to be safe, effective, and tolerable in patients with moderate-to-severe psoriasis.¹ The long-term, follow-up study included patients from the UK and Ireland and found the average SB5 persistence to be 2.5 years, confirming what was found in trials from other countries.

The observational, real-world study involved 1195 patients in the British Association of Dermatologists’ Biologic Interventions Register (BADBIR). More than half of the participants were male (62.8%) with a mean age of 45.7 years. Additionally, 63% of patients had no other comorbidities. Information was collected between June 2018 and August 2022.

Patients had mild or moderate-to-severe psoriasis, which was assessed by Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) at enrollment. The mean baseline PASI was 9.1 and the mean baseline DLQI was 14.6. Throughout the study, investigators measured baseline demographics, disease characteristics, therapy changes, and drug discontinuation. Nearly all patients were biologic-naïve (98.7%). Kaplan-Meier analysis was used to measure discontinuation rates.

Over half of patients (73.5%) remained on SB5 for 1 year. After 4 years, 56.7% continued to receive the drug. Moreover, the average treatment duration was 25.2 months. Of the 490 patients who discontinued treatment (41%), the average was 11.2 months.

13.3% of patients stopped treatment because it was ineffective while 12.6% halted use due to adverse events. Most of these discontinuations occurred within 1 year. For some patients, the timing of the COVID-19 pandemic’s onset may have impacted the decision to discontinue use.

Discontinuation rates were calculated at 1-, 2-, 3-, and 4-year intervals. The rate after 1 year was 26.5% and 37.2% after 2 years. These increased after 3 and 4 years to 41.9% and 43.3%, respectively.

No factors such as age, sex, race, presence of psoriatic arthritis, number of comorbidities, duration of psoriasis, subtype of psoriasis, baseline PASI score, baseline DLQI, and previous biologic therapy use, significantly affected the discontinuation rate. Certain BMI scores may have contributed to a reduced clinical response, but this correlation was not significant and is worth exploring in future research.

“Obesity is a complex disease associated with an increase in several inflammatory markers, leading to chronic low-grade inflammation,” the study authors noted. “Besides its direct impact on inflammation, obesity can also modify the pharmacokinetics (PK) of anti-TNF and other biologic agents. Thus, the impact of obesity on PK may have partially contributed to a reduced clinical response to SB5, i.e., treatment discontinuation.”

The reliance on registry data and the lack of a control group could be considered potential limitations of the research. It can also be difficult to generalize the results to other populations, since the study only included registered patients in the UK and Ireland.

Across the world, adalimumab is currently the most commonly prescribed biologic drug for psoriasis.² However, access may be limited for certain patients due to its high cost. 

SB5, a biosimilar to Humira, was approved for plaque psoriasis and hidradenitis suppurativa treatment by the FDA in November 2023, along with several adalimumab biosimilars.³ With SB5 being an effective and safe treatment option, this could reduce the socio-economic burden for patients who may not have access to other innovator and adalimumab biosimilars.

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. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. doi:10.1016/j.jaad.2018.11.057

3. Samsung Bioepis & Organon announce FDA acceptance of supplemental biologics license application (SBLA) for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira. News release. GlobeNewswire. November 7, 2023. Accessed December 11, 2024. https://www.globenewswire.com/news-release/2023/11/07/2775667/0/en/Samsung-Bioepis-Organon-Announce-FDA-Acceptance-of-Supplemental-Biologics-License-Application-sBLA-for-Interchangeability-Designation-for-HADLIMA-adalimumab-bwwd-a-Biosimilar-to-Hu.html