{
  "abstract": "Objectives Effective, well-tolerated therapies are needed for SLE. Deucravacitinib is an oral, selective tyrosine kinase 2 (TYK2) inhibitor under evaluation in phase 3 SLE studies. Deucravacitinib demonstrated superior efficacy vs placebo (PBO) in the phase 2 PAISLEY SLE study. We report integrated analyses from the PAISLEY SLE (parent; NCT03252587) and long-term extension (LTE; NCT03920267) studies.Methods Patients completing the 48-week parent study while on study drug (deucravacitinib 3 mg twice daily [BID], 6 mg BID, or 12 mg once daily [QD] or PBO) were enrolled in the 3-year LTE ( figure 1). Patients on PBO were rerandomized 1:1:1 to deucravacitinib (blinded); those on deucravacitinib continued for up to 4+ years (222 weeks). Study databases were integrated for analyses of safety through W226 and efficacy through W222. Efficacy analyses were performed using treatment failure rule; patients who discontinued treatment due to lack of efficacy were imputed as nonresponders.Results Of 363 patients from the parent study, 261 (72%) enrolled in the LTE; 151/261 patients (57.9%) completed treatment. Adverse events (AEs) with up to 4+ years of treatment are shown in table 1; serious AEs occurred in 17.0%, 14.9%, and 21.8% of patients who received deucravacitinib 3 mg BID, 6 mg BID, and 12 mg QD, respectively, and AEs leading to treatment discontinuation occurred in 13.4%, 11.4%, and 17.3%, respectively. One death deemed unrelated to study treatment occurred in the deucravacitinib 3-mg BID arm. SRI(4), BICLA, LLDAS, and DORIS remission rates were sustained or improved over time (figure 2); the PBO-switch arm achieved improvements comparable to those of continuously treated patients (figure 2). CLASI-A and active joint count responses were sustained throughout the LTE, with increased responses seen in the PBO-switch arm.Abstract PT4:06 Table 1Safety summary through week 226aAbstract PT4:06 Figure 1Study design: from the PAISLEY SLE parent study to the LTE studyAbstract PT4:06 Figure 2Efficacy in patients treated in the PAISLEY SLE and LTE studiesConclusions Integrated analysis of the PAISLEY SLE and LTE studies confirmed the consistent safety profile and sustained efficacy of deucravacitinib in SLE with up to 4+ years of treatment, with no new safety signals despite complex background therapies. These data represent the longest follow-up of a TYK2 inhibitor in SLE to date, supporting deucravacitinib as a potential long-term treatment option, currently under evaluation in phase 3 POETYK SLE trials ( NCT05617677; NCT05620407).",
  "authors": [
    {
      "affiliations": [
        "Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation and University of Oklahoma Health, Oklahoma City, USA"
      ],
      "name": "Cristina Arriens"
    },
    {
      "affiliations": [
        "School of Clinical Sciences, Monash University, Melbourne, Australia"
      ],
      "name": "Eric F Morand"
    },
    {
      "affiliations": [
        "Rheumatology, MedPharm Consulting, Inc, Bethesda, USA"
      ],
      "name": "Marilyn Pike"
    },
    {
      "affiliations": [
        "University of Oklahoma Health Sciences Center, Oklahoma City, USA"
      ],
      "name": "Joan T Merrill"
    },
    {
      "affiliations": [
        "Department of Dermatology, University of Pennsylvania and Corporal Michael J. Crescenz Department of Veterans Affairs, Philadelphia, USA"
      ],
      "name": "Victoria P Werth"
    },
    {
      "affiliations": [
        "University of Toronto Lupus Clinic, Centre for Prognosis Studies in the Rheumatic Diseases, Toronto Western Hospital, Toronto, Canada"
      ],
      "name": "Zahi Touma"
    },
    {
      "affiliations": [
        "Medart Cliniq, Department of Rheumatology, Râmnicu Vâlcea, Romania"
      ],
      "name": "Razvan C Ionitescu"
    },
    {
      "affiliations": [
        "St. Luke’s International Hospital, Tokyo, Japan"
      ],
      "name": "Masato Okada"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Boudry, Switzerland"
      ],
      "name": "Ilias Kouris"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, USA"
      ],
      "name": "Yogita Kolekar"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, USA"
      ],
      "name": "Junyu Nie"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, USA"
      ],
      "name": "Venkat Renukuntla"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, USA"
      ],
      "name": "Thomas Wegman"
    },
    {
      "affiliations": [
        "Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, The Netherlands"
      ],
      "name": "Ronald F Van Vollenhoven"
    }
  ],
  "title": "PT4:06 Four-year safety and efficacy of deucravacitinib in systemic lupus erythematosus: results from the phase 2 PAISLEY SLE trial",
  "uid": "ea1b29c4-5127-57f6-a9e4-4e04c4f5816a"
}