Deucravacitinib, an Oral, Allosteric, Tyrosine Kinase 2 (TYK2) Inhibitor, in Patients with Active Systemic Lupus Erythematosus: Patient-Reported Outcomes in a Phase 2 Trial

Marta Mosca¹, Laurent Arnaud², Anca Askanase³, Coburn Hobar⁴, Brandon Becker⁵, Shalabh Singhal⁴, Subhashis Banerjee⁴, Samantha Pomponi⁴, Jiyoon Choi⁵, Adrian Coles⁵ and Vibeke Strand⁶, ¹Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy, ²University Hospitals of Strasbourg, Strasbourg, France, ³Columbia University Medical Center, New York, NY, ⁴Bristol Myers Squibb, Princeton, NJ, ⁵Bristol Myers Squibb, Lawrenceville, NJ, ⁶Stanford University, Portola Valley, CA

Meeting: ACR Convergence 2023

Keywords: Patient reported outcomes, Systemic lupus erythematosus (SLE)

Session Information

Date: Tuesday, November 14, 2023

Title: (2326–2351) SLE – Treatment Poster III

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[4]) 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.

Disclosures: M. Mosca: AstraZeneca, 2, Bristol-Myers Squibb(BMS), 2, Eli Lilly, 2, GlaxoSmithKlein(GSK), 2, Otsuka, 2, UCB, 2; L. Arnaud: AbbVie, 6, Alexion, 6, Alpine, 2, 6, Amgen, 6, AstraZeneca, 1, 2, 6, Biogen, 6, Boehringer Ingelheim, 6, Bristol-Myers Squibb(BMS), 2, 6, Eli Lilly, 6, GlaxoSmithKlein(GSK), 1, 2, 6, Grifols, 6, Janssen, 6, Kezar Life Sciences, 2, 6, LFB, 6, Medac, 6, Novartis, 2, 6, Pfizer, 6, Roche-Chugaï, 6, UCB, 6; A. Askanase: AbbVie, 2, Amgen, 2, AstraZeneca, 2, Aurinia, 2, Bristol-Myers Squibb, 2, Celgene, 2, Eli Lilly, 2, Genentech, 2, GSK, 2, Idorsia, 2, Janssen, 2, Mallinckrodt, 2, Pfizer, 2, UCB Pharma, 2; C. Hobar: Bristol-Myers Squibb(BMS), 3; B. Becker: Bristol-Myers Squibb(BMS), 3; S. Singhal: Bristol-Myers Squibb(BMS), 3; S. Banerjee: Bristol-Myers Squibb(BMS), 3, 11; S. Pomponi: Bristol-Myers Squibb(BMS), 3; J. Choi: Bristol Myers Squibb, 3; A. Coles: Bristol-Myers Squibb(BMS), 3; V. Strand: Abbvie, 2, Alpine Immune Sciences, 2, Amgen, 2, Arena, 2, AstraZeneca, 2, Bayer, 2, Biosplice, 2, Bioventus, 2, Blackrock, 2, 2, BMS, 2, Boehringer Ingelheim, 2, Celltrion, 2, Chemocentryx, 2, EMD Serono, 2, Equillium, 2, Ermium, 2, Eupraxia Pharmaceuticals, 2, Flexion, 2, Galapagos, 2, Genentech/Roche, 2, Gilead, 2, GlaxoSmithKline, 2, Horizon, 2, Ichnos, 2, Inmedix, 2, Janssen, 2, Kiniksa, 2, 2, Kypha, 2, Lilly, 2, Merck, 2, MiMedx, 2, Novartis, 2, Omeros, 2, Pfizer, 2, Regeneron, 2, Rheos, 2, R-Pharm, 2, Samsung, 2, Sandoz, 2, Sanofi, 2, Scipher, 2, Setpoint, 2, Sorrento, 2, Spherix, 2, Tonix, 2, UCB, 2, Urica, 2.

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 .

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/