The Effectiveness of Guselkumab by BMI Category Among Patients with Moderate-to-Severe Plaque Psoriasis in the CorEvitas Psoriasis Registry.

INTRODUCTION: Prior studies have demonstrated guselkumab improves disease activity and patient-reported outcomes (PROs) among patients with moderate-to-severe plaque psoriasis. However, the real-world effectiveness of guselkumab across different subgroups [e.g., body mass index (BMI) categories] remains an area of active research. METHODS: This study included patients enrolled in the CorEvitas Psoriasis Registry between July 18, 2017 and March 10, 2020 who had moderate-to-severe psoriasis [Investigator's Global Assessment (IGA) score ≥ 3], initiated guselkumab at a registry visit (index date), and had a follow-up registry visit after persistent guselkumab therapy for 9-12 months. Patients were stratified into three BMI categories: obese (≥ 30 kg/m2), overweight (25- < 30 kg/m2), and underweight/normal weight (< 25 kg/m2). Response rates and mean changes for disease activity outcomes and PROs at follow-up were assessed within each BMI category. RESULTS: Of the 180 patients included in the study, 101 (56%) were obese, 52 (29%) were overweight, and 27 (15%) were underweight/normal weight. Among the obese, overweight, and underweight/normal weight patients, 57%, 58%, and 72%, respectively, achieved an IGA score of 0/1 after 9-12 months of persistent guselkumab treatment. An IGA score of 0 was achieved by 33%, 35%, and 48% of obese, overweight, and underweight/normal weight patients, respectively. A 90% improvement in the Psoriasis Area and Severity Index was achieved by 46%, 46%, and 56% in these respective subgroups. Mean improvements in disease activity and PRO scores were similar among BMI subgroups. CONCLUSION: The results of this real-world study showed improvements in disease severity and several PRO scores within all BMI categories among patients with moderate-to-severe psoriasis treated with guselkumab. These unadjusted findings suggest that obese and overweight patients have comparable absolute improvements to those with lower BMI; however, they may be less likely to achieve relative endpoints. Additional analyses are needed to fully characterize this relationship.

Real-World Effectiveness of 9-12 Months of Guselkumab Therapy among Patients with Moderate-to-Severe Plaque Psoriasis in the CorEvitas Psoriasis Registry.

INTRODUCTION: Guselkumab, an anti-interleukin-23 biologic therapy, has been shown to significantly reduce disease activity and improve patient-reported outcome measures (PROMs) among patients with moderate-to-severe plaque psoriasis in clinical trials. However, characterization of the real-world effectiveness of guselkumab among patients living in the USA and Canada is warranted. METHODS: Patients who participated in the CorEvitas Psoriasis Registry between 18 July 2017 and 10 March 2020 were included if they met the following criteria: Investigator's Global Assessment (IGA) score ≥ 3 and body surface area (BSA) ≥ 10% (moderate-to-severe psoriasis), initiated guselkumab at a registry (index) visit, and had a registry follow-up visit after 9-12 months of persistent guselkumab therapy. Data were retrieved for baseline patient demographics and disease characteristics, treatment history, disease activity, and PROMs. Outcomes were assessed at index and follow-up visits; response rates and mean changes were calculated. RESULTS: Among 113 patients, mean age was 49.7 years, mean psoriasis duration was 17.5 years, and 65.5% of patients were biologic experienced. At baseline, mean IGA score was 3.3, Psoriasis Area Severity Index (PASI) score was 13.6, and Dermatology Life Quality Index (DLQI) score was 9.6. At follow-up, IGA 0/1, PASI 90, and DLQI 0/1 were achieved by 62.2%, 56.8%, and 54.7% of patients, respectively. Statistically significant improvements were observed in all disease activity scores and PROMs, including the EuroQoL Visual Analogue Scale, Work Productivity and Activity Impairment, Patient Global Assessment, fatigue, skin pain, and itch (p < 0.05). CONCLUSIONS: This real-world study showed that patients with moderate-to-severe psoriasis who received 9-12 months of persistent guselkumab therapy experienced improvements in disease severity and PROMs.

Effectiveness of Guselkumab Therapy among Patients with Plaque Psoriasis with Baseline IGA Score ≥ 2 in the CorEvitas Psoriasis Registry.

INTRODUCTION: In clinical trials, treatment with the interleukin-23 inhibitor guselkumab was associated with significantly improved disease severity and patient-reported outcome measures (PROMs) among patients with moderate-to-severe plaque psoriasis. However, limited information is available regarding the real-world effectiveness of guselkumab among patients with psoriasis of mild, moderate, and severe Investigator's Global Assessment (IGA) severities living in the USA and Canada. METHODS: Patients participating in the CorEvitas Psoriasis Registry between 18 July 2017 and 10 July 2019 who met the following criteria were included: IGA ≥ 2 (mild or greater disease severity), initiated guselkumab at a registry (index) visit, and had a registry follow-up visit after persistent guselkumab treatment for 9 to 12 months. Data were collected for patient demographics, disease characteristics, treatment history, disease activity, and PROMs. At follow-up, outcome measure response rates and mean changes from the index visit were calculated. RESULTS: Among 130 patients, the mean age was 50.2 years, 39.2% were female, and 56.9% had a body mass index ≥ 30 kg/m2. Mean psoriasis duration was 17.5 years and 79.2% of patients had previously received one or more biologic therapy. At the index visit, mean IGA, Psoriasis Area Severity Index (PASI), and Dermatology Life Quality Index (DLQI) scores were 3.0, 9.9, and 8.0, respectively. At follow-up, IGA 0/1 and IGA 0 were achieved by 64.6% and 36.2% of patients, respectively. PASI 75, 90, and 100 were achieved by 61.5%, 46.9%, and 36.9% of patients; 55.4% had maintained or achieved DLQI 0/1. Mean improvements were observed in all evaluated disease activity outcomes and PROMs, with all differing significantly from zero except for the percent of work hours missed due to psoriasis. CONCLUSION: In this real-world study, patients with a baseline IGA score ≥ 2 experienced improvements in disease activity and PROMs after 9-12 months of persistent guselkumab treatment.