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Resolution of enthesitis by guselkumab and relationships to disease burden: 1-year results of two phase 3 psoriatic arthritis studies
- Source :
- Rheumatology (Oxford, England)
- Publication Year :
- 2021
-
Abstract
- Objective To further characterize the effect of guselkumab, a selective IL-23p19-subunit inhibitor approved for PsA, on enthesitis and assess relationships between enthesitis resolution and patient status/outcomes. Methods Adults with active PsA despite standard therapies in the phase 3 DISCOVER-1 and DISCOVER-2 studies were randomized 1:1:1 to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at week 0, week 4, Q8W; or placebo through week 20 followed by guselkumab 100 mg Q4W. Independent assessors evaluated enthesitis using the Leeds Enthesitis Index (LEI; total score 0–6). Enthesitis findings through week 24 were pre-specified to be pooled across studies; post hoc and week 52 analyses also employed pooled data. Results Among 1118 randomized, treated patients in DISCOVER-1 and 2 who had ≥1 LEI site evaluated, 65% had enthesitis at baseline. These patients exhibited numerically more swollen and tender joints, systemic inflammation and impaired physical function than patients without enthesitis. Guselkumab Q4W and Q8W were superior to placebo in resolving pre-existing enthesitis at week 24 (45 and 50% vs 29%; both adjusted P = 0.0301). Enthesitis resolution rates continued to rise; 58% of guselkumab-randomized patients achieved resolution at week 52, including patients with mild (LEI = 1; 70–75%), moderate (LEI = 2; 69–73%) or severe (LEI = 3–6; 42–44%) enthesitis at baseline. Among guselkumab-randomized patients with resolved enthesitis at week 24, 42% achieved minimal disease activity at week 52, vs 17% of patients with unresolved enthesitis. Conclusion Guselkumab resulted in higher proportions of PsA patients with resolved enthesitis by week 24, with maintenance of resolution rates through 1 year. As enthesitis confers greater disease burden, sustained resolution could portend better patient outcomes. Clinical trial registration DISCOVER 1 (NCT03162796) and DISCOVER 2 (NCT03158285)
- Subjects :
- Adult
Male
medicine.medical_specialty
Enthesopathy
Placebo
Antibodies, Monoclonal, Humanized
Psoriatic arthritis
entheses
Rheumatology
Internal medicine
medicine
Humans
p19 protein
Pharmacology (medical)
Pooled data
Disease burden
AcademicSubjects/MED00360
psoriatic arthritis
business.industry
interleukin-23
Arthritis, Psoriatic
Enthesitis
Middle Aged
Clinical Science
spondyloarthritis
medicine.disease
Enthesitis index
Clinical trial
Guselkumab
Interleukin-23 Subunit p19
Female
medicine.symptom
business
biologic
Subjects
Details
- ISSN :
- 14620332 and 03162796
- Volume :
- 60
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- Rheumatology (Oxford, England)
- Accession number :
- edsair.doi.dedup.....f28948d91360fc594246ac14b0d1d5ca