Session Type: Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in the US, EU, and other countries for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. In PAISLEY, a 48-week, phase 2, randomized controlled trial that assessed deucravacitinib in patients with active systemic lupus erythematosus (SLE), a greater proportion of patients receiving deucravacitinib treatment achieved SLE Responder Index-4 (SRI) responses at Weeks 32 and 48 vs placebo. Patient-reported outcomes (PROs) were collected as exploratory endpoints.
Methods: All patients met Systemic Lupus International Collaborating Clinics classification criteria, were seropositive for antinuclear antibody, anti-double-stranded DNA, or anti-Smith antibody, and had Systemic Lupus Erythematosus Activity Index 2000 total score ≥6 points and clinical score ≥4 points. Patients (N=363) were randomized 1:1:1:1 to placebo (n=90) or deucravacitinib 3 mg twice daily (BID; n=91), 6 mg BID (n=93), or 12 mg once daily (QD; n=89). Patients assessed pain levels on a numeric rating scale (NRS) and completed the Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue 7a Short Form and 36-Item Short Form Health Survey (SF-36). Missing data were imputed using control-based pattern imputation. Results were descriptive.
Results: Baseline characteristics were comparable across groups (Table 1). At Week 48, greater mean changes from baseline in pain and fatigue were reported with deucravacitinib 3 mg BID, 6 mg BID, and 12 mg QD vs placebo, including achievement of the minimal clinically important differences (MCID) of −1 and −4 for both pain and fatigue with all doses of deucravacitinib vs for pain only with placebo (Figure 1). Patients treated with deucravacitinib reported greater achievement of changes associated with MCID for pain (−1), fatigue (−4), and SF-36 MCS and PCS (−2.5) vs placebo (Table 2). Mean scores (SD) at Week 48 numerically improved with deucravacitinib 3 mg BID, 6 mg BID, and 12 mg QD vs placebo, respectively: Pain NRS: 3.6 (2.7), 3.7 (2.6), 3.6 (2.8), and 4.7 (2.7); PROMIS Fatigue: 52.4 (10.2), 52.6 (10.0), 51.9 (10.6), and 54.4 (10.9); SF-36 PCS: 44.7 (10.0), 44.6 (9.3), 45.1 (11.0), and 41.5 (10.5); and SF-36 MCS: 46.7 (12.6), 46.3 (13.1), 47.3 (12.6), and 45.2 (12.9).
Conclusion: Patients with SLE who received deucravacitinib reported improvements over patients who received placebo on pain and fatigue, and in health-related quality of life at Week 48.
To cite this abstract in AMA style:Mosca M, Arnaud L, Askanase A, Hobar C, Becker B, Singhal S, Banerjee S, Pomponi S, Choi J, Coles A, Strand V. Deucravacitinib, an Oral, Allosteric, Tyrosine Kinase 2 (TYK2) Inhibitor, in Patients with Active Systemic Lupus Erythematosus: Patient-Reported Outcomes in a Phase 2 Trial [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/deucravacitinib-an-oral-allosteric-tyrosine-kinase-2-tyk2-inhibitor-in-patients-with-active-systemic-lupus-erythematosus-patient-reported-outcomes-in-a-phase-2-trial/. Accessed .
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/deucravacitinib-an-oral-allosteric-tyrosine-kinase-2-tyk2-inhibitor-in-patients-with-active-systemic-lupus-erythematosus-patient-reported-outcomes-in-a-phase-2-trial/