Long-Term Efficacy and Safety of Guselkumab for Moderate to Severe Psoriasis: A 3-Year Real-Life Retrospective Study

Abstract

Introduction Guselkumab safety and efficacy profiles in psoriasis have been showed by VOYAGE (1 and 2) trials. Although trial results have been already previously confirmed by real-life studies, long-term real-life data, and drug survival data about guselkumab are still poor. Patients and Methods We performed a 3-year retrospective study, with the aim of assessing guselkumab efficacy and safety profile in the management of plaque psoriasis in a real-life setting. Results Thirty-one patients completed the study. Both Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) statistically improved since week 16, and up to week 144 [PASI reduction from 16.4 ± 6.2 to 0.6 ± 0.9 (p < 0.0001) at week 144 while BSA from 33.2 ± 14.6 to 1.9 ± 1.4 (p < 0.0001)]. At week 12 PASI90 and PASI100 were achieved by 19 (61.3%) and 11 (35.4%) patients, respectively, as well as 24 (77.4%) and 18 (58.1%) subjects reached PASI 90 and PASI 100 at week 144. As regards the safety, no cases of injection site reaction, candida, serious AEs, malignancy, or major cardiovascular events were reported. Of note, mild AEs were collected with pharyngitis as the main one (7, 22.6%), followed by headache (5, 16.1%) and flu-like illness (5, 16.1%), all without requiring treatment discontinuation. Conclusion Our experience confirmed the efficacy and safety of guselkumab in daily clinical practice up to 3 years, suggesting this drug as an effective treatment option in psoriasis long-term management.

Long-Term Efficacy, Safety, and Drug Survival of Guselkumab in Patients with Psoriasis: Real-World Data from the Czech Republic BIOREP Registry

“…This is close to the results by Megna et al. (PASI 90 in 77.4% and PASI 100 in 54.8%, after 120 weeks) [ 16 ].…”

“…Real-world evidence for mean PASI score with a treatment duration of about 3 years is available only from Megna et al. (120 weeks) with a slightly worse result (mean PASI 1.0) [ 16 ].…”

Guselkumab effectiveness and survival in patients with psoriasis and psoriatic arthritis: Multicenter analysis in daily clinical practice by the Spanish Psoriasis Group

“…A number of studies have shown the efficacy and safety of guselkumab for PsO treatment in a real world setting. Benhadou et al 27 reported the efficacy and safety in the short term, while Megna et al 28 reported the long‐term benefit of guselkumab after 3 years of therapy. Moreover, the German registry PERSIST confirmed the efficacy and safety in the short and the long term 18 .…”

Outcomes of Biologic Use in Asian Compared with Non-Hispanic White Adult Psoriasis Patients from the CorEvitas Psoriasis Registry

“…The advent of biologic agents over nearly two decades has dramatically enhanced the treatment of moderate to severe psoriasis. Data from randomized controlled trials (RCTs) [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16] have demonstrated that these agents can be highly efficacious. Yet the preponderance of evidence has been garnered from studies that have primarily included White patients.…”

“…However, while prior real-world evidence (RWE) studies have demonstrated the effectiveness of biologic therapies for psoriasis [4][5][6][7][8][9][10][11][12][13][14][15][16], there is little published data comparing the efficacy of biologics in Asian compared with other ethnicities in RWE studies. Real-world evidence is essential for providing insight into the efficacy and safety of drug treatments across all patients with psoriasis since the typical strict inclusion criteria of RCTs often exclude many patient populations seen in routine clinical care, including those with multiple comorbidities, ethnic and racial subpopulations, older adults, and patients for whom multiple biologics have failed.…”