Humira Biosimilar Effective in Treating Moderate to Severe Chronic Plaque Psoriasis

Samsung Bioepis Co., Ltd. and Organon & Co. recently showcased results from an interchangeability study for SB5 (adalimumab-bwwd), marketed under the brand name Hadlima as a biosimilar to adalimumab (ADL) (Humira; AbbVie), in patients with plaque psoriasis. The phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study (NCT05510063) evaluated the pharmacokinetic similarity between 2 treatment groups. Patients with moderate to severe plaque psoriasis either switched multiple times between subcutaneous injections of ADL and high-concentration SB5 or remained on ADL continuously throughout the study. The efficacy, safety, and immunogenicity profiles were compared between the 2 patient groups.¹

Scientists in biochemical laboratory | JackF | stock.adobe.com

A total of 371 participants who were diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months were examined from August 2022 to May 2023. Patients had to be aged 18 to 80 years without a history of ADL treatment, cell-depleting biologics, and other biologic use within 6 months prior to week 0 of the study.¹ At week 0, every patient received an initial dose of 80 mg of ADL, followed by 40 mg every other week until week 11. At week 13, patients who reached at least a 50% reduction in Psoriasis Area and Severity Index (PASI50) response were either, depending on a randomized 1:1 ratio, switched from ADL to SB5 or continued using ADL until week 23.²

The study was able to achieve all primary endpoints (pharmacokinetic endpoints of AUCtau and Cmax) at weeks 23 to 25, with efficacy profiles, safety profiles, and immunogenicity being comparable between the 2 treatment groups. For comparisons of all primary endpoints between the multiple-switching group and the ADL-continued group, the 90% confidence intervals (CI) were fully included in the pre-defined margins, with 90% CI for the ratio of geometric least squares mean of AUCtau and Cmax for week 23 to 25 (0.8007, 1.1115 and 0.8637, 1.1433, respectively). Both were included in the pre-defined margin of 0.8 and 1.25.²

SB5 is a tumor necrosis factor (TNF) blocker initially approved by the US Food and Drug Administration (FDA) in July 2019 as a low-concentration (50 mg/mL) formulation of prefilled syringe and prefilled autoinjector. The high-concentration (100 mg/mL) formulation of prefilled syringe and prefilled autoinjector of SB5 was approved 3 years later in August 2022.

Previously, 40 mg/0.4 mL and 40 mg/0.8 mL injections of SB5 were used to either treat or reduce symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, and ulcerative colitis. Prior to the current study, the effectiveness of SB5 had not been established in patients who either lost response or were intolerant to TNF blockers. SB5 is indicated for the treatment of moderate to severe chronic plaque psoriasis, hidradenitis suppurativa, and uveitis.²

It is recommended that patients who are using SB5 do not receive live vaccines and pediatric patients are brought up to date with their immunizations before beginning therapy. Patients who are treated with ADL products, including SB5, are at an increased risk for developing serious infections that may result in hospitalization or death; however, the majority of patients who had developed this adverse effect (AE) were taking accompanying immunosuppressants (e.g., methotrexate, corticosteroids).²

Patients treated with SB5 had reported various AEs, including infections, lymphoma and other malignancies, hypersensitivity, hepatitis B virus, neurologic reactions (e.g., multiple sclerosis, optic neuritis, Guillain-Barré syndrome), hematologic reactions (e.g., pancytopenia and aplastic anemia), congestive heart failure, and autoimmunity. The most common AEs across previous clinical studies (>10%) using SB5 include infections (e.g., upper respiratory, sinusitis), injection site reactions, headaches, and rash.²

References

1. Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis. clinicaltrials.gov. Accessed August 2, 2023. Retrieved from: https://classic.clinicaltrials.gov/ct2/show/NCT05510063

2. Samsung Bioepis. Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar. News release. August 1, 2023. Accessed on August 2, 2023. https://bit.ly/3Kn462h