Guselkumab Shows Strong Response in Long-Term Subtype Psoriasis Study

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Recent research published in The Journal of Dermatology evaluated the real-world safety and effectiveness of guselkumab in Japanese patients with psoriasis. The prospective, post-marketing surveillance study was conducted over a 52-week period, assessing patient response to guselkumab treatment. With the aim to provide insight into the safety profile and treatment efficacy of guselkumab across different psoriasis subtypes, the study demonstrated that guselkumab was “well-tolerated and effective” in Japanese patients with psoriasis. Researchers noted no new safety concerns, and stated that bio-naïve patients and patients without comorbidity achieved particularly high levels of response.¹

Background

The most common subtype of psoriasis is plaque psoriasis (PsV), though other forms include guttate psoriasis, pustular psoriasis (GPP), and erythrodermic psoriasis (EP). Psoriatic arthritis (PsA) is a related inflammatory condition affecting the joints.² In Japan, the prevalence of psoriasis is estimated at 0.34%, lower than rates observed in European populations.³

Guselkumab, an IL-23p19 inhibitor, has shown promising efficacy in clinical trials for moderate to severe psoriasis. Given the limited inclusion of patients previously treated with systemic therapies in clinical trials, real-world studies are crucial to understanding its effectiveness in a broader patient population.⁴

Methods and Materials

A multicenter, single-arm, prospective post-marketing surveillance study was conducted in Japan. Patients were observed for 52 weeks following their initial guselkumab injection (100 mg at weeks 0 and 4, then every 8 weeks). Data collection included baseline demographics, disease severity, treatment history, and concomitant medications. Adverse events (AEs), serious AEs (SAEs), and adverse drug reactions (ADRs) were recorded. Treatment effectiveness was assessed using Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and Disease Activity Score 28 (DAS28) for PsA.

Study Results

A total of 428 patients were enrolled, with 416 included in the safety analysis set. PsV was the most common diagnosis (74.5%), followed by PsA (18.0%), GPP (6.3%), and EP (1.2%). The median age across subtypes ranged from 58 to 63 years.

During the study, 8.4% of patients reported ADRs, including 3.4% who discontinued treatment due to AEs. The most common ADRs were infections and hypersensitivity reactions. Serious infections occurred in 4 patients, and 2 malignancies were reported. PASI 75, 90, and 100 response rates at week 52 were 69.9%, 54.5%, and 32.5%, respectively, indicating a strong clinical response. Bio-naïve patients had higher PASI 75 and 90 response rates compared to bio-experienced patients. Researchers reported DLQI scores significantly improved, with nearly 90% of patients achieving a score of ≤5, reflecting improved quality of life. DAS28 scores also decreased, indicating reduced disease activity in PsA patients.

Discussion

The study found guselkumab demonstrated a favorable safety profile and sustained efficacy in Japanese patients with psoriasis. The incidence of ADRs was relatively low, with infections being the most notable concern. Bio-naïve patients showed stronger responses to treatment, which supports the early use of guselkumab in those with recent onset psoriasis, though bio-experienced patients also achieved significant improvements. These findings support the use of guselkumab in moderate to severe psoriasis, particularly in patients unresponsive to other systemic therapies.

Conclusion

This real-world study confirms the efficacy and safety of guselkumab in treating psoriasis subtypes over 52 weeks. While some adverse effects were observed, researchers stated the overall benefit-risk profile remains positive. They suggested further long-term studies are needed to evaluate sustained treatment outcomes and optimize patient selection criteria for guselkumab therapy.

References

1. Tada Y, Sugiura Y, Kamishima M, et al. Real-world safety and effectiveness of guselkumab in patients with psoriasis: A post-marketing surveillance study through up to week 52 in Japan. J Dermatol. 2025; 00: 1–16. doi:10.1111/1346-8138.17710
2. Armstrong AW, Read C. Pathophysiology, clinical presentation, and treatment of psoriasis: A review. JAMA. 2020;323(19):1945-1960. doi:10.1001/jama.2020.4006
3. Kubota K, Kamijima Y, Sato T, et al. Epidemiology of psoriasis and palmoplantar pustulosis: a nationwide study using the Japanese national claims database. BMJ Open. 2015;5(1):e006450. Published 2015 Jan 14. doi:10.1136/bmjopen-2014-006450
4. Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417. doi:10.1016/j.jaad.2016.11.041