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  • LO-015 Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in a phase 2 trial in systemic lupus erythematosus (SLE): achievement of sustained SRI(4), BICLA, and dual responses over 48 weeks

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Oral Presentation
Plenary session 3: novel treatments and strategies
LO-015 Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in a phase 2 trial in systemic lupus erythematosus (SLE): achievement of sustained SRI(4), BICLA, and dual responses over 48 weeks
  1. Richard Furie1,
  2. Cristina Arriens2,3,
  3. Kenneth B Kalunian4,
  4. Marilyn Pike5,
  5. Ronald van Vollenhoven6,
  6. Coburn Hobar7,
  7. Ayanbola Elegbe8,
  8. Samantha Pomponi9,
  9. Subhashis Banerjee7,
  10. Shalabh Singhal7,
  11. Thomas Wegman7 and
  12. Eric Morand10
  1. 1Rheumatology, Northwell Health, USA
  2. 2Arthritis and Clinical Immunology, Rheumatology, Oklahoma Medical Research Foundation, USA
  3. 3Medicine, University of Oklahoma Health Sciences Center, USA
  4. 4Rheumatology, Allergy and Immunology, University of California San Diego, USA
  5. 5Rheumatology, MedPharm Consulting, Inc, Netherlands
  6. 6Rheumatology, Amsterdam University Medical Centers, Netherlands
  7. 7Clinical Development, Bristol Myers Squibb, USA
  8. 8Global Biometrics and Data Sciences, Bristol Myers Squibb, USA
  9. 9Worldwide Medical, Bristol Myers Squibb, USA
  10. 10School of Clinical Sciences, Monash University, Australia

Abstract

Background Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in multiple countries for the treatment of adults with plaque psoriasis.1 2 In a phase 2 trial in SLE patients on background standard therapy, deucravacitinib demonstrated efficacy vs placebo across multiple endpoints, including SRI(4) at week 32 (primary endpoint) and at week 48 (secondary endpoint), as well as BICLA at week 48 (secondary endpoint).3 This post-hoc analysis further evaluated efficacy and time to response with deucravacitinib vs placebo in these responses in the phase 2 trial.

Methods This 48-week, double-blind trial (NCT03252587) randomized 363 patients with active SLE 1:1:1:1 to placebo or deucravacitinib 3 mg BID, 6 mg BID, or 12 mg QD. Endpoints included the proportions of patients achieving SRI(4), BICLA, and simultaneous (dual) SRI(4)/BICLA responses at weeks 32 and 48, proportions of patients with sustained responses through week 48 (responder at every visit from week 32 through week 48), and time to onset of responses. BICLA response, and therefore dual response, were measurable at the first visit after steroid taper completion (week 24 [day 168]). Analyses were descriptive.

Results At weeks 32 and 48, SRI(4), BICLA, and dual response rates were numerically higher with deucravacitinib vs placebo (figure 1). Median time intervals to onset of SRI(4), BICLA, and dual responses were lower with deucravacitinib treatment compared with placebo (table 1). Median times to onset of dual response were 196–282 days with deucravacitinib. A higher percentage of patients treated with deucravacitinib sustained their SRI(4), BICLA, and dual responses through week 48 vs placebo (table 1).

Conclusions Deucravacitinib treatment elicited higher and faster SRI(4), BICLA, and dual responses compared with placebo. Patients were more likely to sustain their treatment responses from weeks 32 through 48 with deucravacitinib treatment vs placebo. These data support the robust efficacy of deucravacitinib across multiple SLE response indices.

Abstract LO-015 Figure 1
Abstract LO-015 Figure 1

SRI(4), BICLA, and dual responses at weeks 32 and 48

View this table:
Abstract LO-015 Table 1

SRI(4), BICLA, and dual SRI(4)/BICLA: responses at week 32, sustained responses, and time to responses

References

  1. Armstrong A, et al. J Am Acad Dermatol. 2023;88(1):29–39.

  2. Strober B, et al. J Am Acad Dermatol. 2023;88(1):40–51.

  3. Morand E, et al. Arthritis Rheumatol. 2022; Nov 11 (Epub ahead of print).

  • TYK2
  • deucravacitinib
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/lupus-2023-KCR.15

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