Date: Friday, November 6, 2020
Session Type: Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Guselkumab (GUS), a monoclonal antibody that specifically binds to the p19 subunit of IL-23, is approved for psoriasis. In the DISCOVER-2 Phase 3 trial in patients with psoriatic arthritis (PsA), the treatment effect of GUS on patient-reported symptoms and Health Related Quality of Life (HRQOL) as related to psoriatic skin was assessed.
Methods: For DISCOVER-2, adults with active PsA (≥5 swollen + ≥5 tender joints; CRP ≥0.6 mg/dL) despite standard therapies (eg, non-biologic DMARDs, apremilast, or NSAIDs) were eligible. Patients in the HRQOL analyses also had baseline ≥3% Body Surface Area (BSA) of psoriatic involvement and an Investigators Global Assessment (IGA) Score ≥2 (mild). Patients were randomized 1:1:1, stratified by Week 0 DMARD use (Yes/No) and the most recent CRP value prior to randomization (< 2.0 mg/dL vs ≥2.0 mg/dL), to GUS 100 mg every 4 weeks (Q4W); GUS 100 mg at Week 0, Week 4, then every 8 weeks (Q8W); or Placebo. Concomitant stable use of select non-biologic DMARDs, oral corticosteroids, and NSAIDs was allowed. At Week 16, patients with < 5% improvement in tender+swollen joints could initiate or increase the dose of permitted medications while continuing study treatment. Dermatology Life Quality Index (DLQI), a validated endpoint, assessed skin-related symptoms and HRQOL at Weeks 8, 16, 24, and 52. Skin-related symptom-free was defined as a DLQI item-1 score=0, and no impact of skin condition on HRQOL was defined as total DLQI score=0 or 1.
Results: Among 738 treated patients (248 GUS Q8W, 245 GUS Q4W, and 245 Placebo), baseline mean (standard deviation [SD]) DLQI score was 9.9 (7.5), indicating the great impact of skin disease on patients’ HRQOL. Baseline mean (SD) % BSA (n=736) was 17.4% (20.4%) and IGA score ≥2 (n=738) was reported for 82% of patients. A greater proportion of patients treated with GUS 100 mg Q8W (54.3%) or 100 mg Q4W (49.6%) was observed for psoriasis symptom-free at Week 24 vs Placebo (16.9%) (each nominal p< 0.001). A greater mean change from baseline was observed for DLQI total score at Week 24 in patients treated with GUS 100 mg QW8 (n=175) (-8.95 [95% CI -9.691, -8.218]) or 100 mg Q4W (n=184) (‑8.85 [95% CI -9.581, -8.124]) vs placebo (n=182) (-2.13 [95% CI -2.854, -1.404]) (each nominal p< 0.001), and the least squares mean difference was observed as early as Week 8 (each nominal p< 0.001). At Week 24, a greater proportion of patients treated with GUS 100 mg Q8W (101 [63.9%]) or 100 mg Q4W (102 [59.0%]) achieved a DLQI score of 0 or 1 vs Placebo (20 [11.8%]) (each p< 0.001), indicating no impact of skin disease on their HRQOL. Similarly, greater improvements in each of the 6 DLQI domain subscores at Week 24 were observed in GUS-treated patients vs Placebo (Table 1). The greater mean changes from baseline in DLQI total and subscores observed at Week 24 were sustained through Week 52 (Table 2). Placebo-treated patients who switched to GUS 100 mg Q4W at Week 24 achieved improvement in DLQI score, which was comparable with originally randomized patients who received GUS.
Conclusion: The majority of GUS-treated patients with PsA achieved skin-related symptom-free and no impact of skin condition on their HRQOL.
To cite this abstract in AMA style:Dutz J, Merola J, Han C, Kollmeier A, Zhou B, Agarwal P, Yang Y, Shawi M, Deodhar A. Patients with Psoriatic Arthritis Treated with Guselkumab Achieved Psoriasis-Related Symptom-Free State and Had No Skin Condition Impact on Their Health Related Quality of Life [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/patients-with-psoriatic-arthritis-treated-with-guselkumab-achieved-psoriasis-related-symptom-free-state-and-had-no-skin-condition-impact-on-their-health-related-quality-of-life/. Accessed December 1, 2022.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/patients-with-psoriatic-arthritis-treated-with-guselkumab-achieved-psoriasis-related-symptom-free-state-and-had-no-skin-condition-impact-on-their-health-related-quality-of-life/