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Clinical Trial
. 2022 Jun;81(6):815-822.
doi: 10.1136/annrheumdis-2021-221664. Epub 2022 Mar 3.

Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis

Philip J Mease  1 , Atul A Deodhar  2 , Désirée van der Heijde  3 , Frank Behrens  4 , Alan J Kivitz  5 , Jeffrey Neal  6 , Jonghyeon Kim  7 , Shalabh Singhal  7 , Miroslawa Nowak  7 , Subhashis Banerjee  7
Affiliations
Clinical Trial

Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis

Philip J Mease et al. Ann Rheum Dis. 2022 Jun.

Abstract

Objective: To evaluate the efficacy and safety of an oral selective tyrosine kinase 2 (TYK2) inhibitor, deucravacitinib, in patients with active psoriatic arthritis (PsA).

Methods: In this double-blind, phase II trial, 203 patients with PsA were randomised 1:1:1 to placebo, deucravacitinib 6 mg once a day or 12 mg once a day. The primary endpoint was American College of Rheumatology-20 (ACR-20) response at week 16.

Results: ACR-20 response was significantly higher with deucravacitinib 6 mg once a day (52.9%, p=0.0134) and 12 mg once a day (62.7%, p=0.0004) versus placebo (31.8%) at week 16. Both deucravacitinib doses resulted in significant improvements versus placebo (p≤0.05) in the multiplicity-controlled secondary endpoints of change from baseline in Health Assessment Questionnaire-Disability Index and Short Form-36 Physical Component Summary score and in Psoriasis Area and Severity Index-75 response. Improvements were also seen in multiple exploratory endpoints with deucravacitinib treatment. The most common adverse events (AEs) (≥5%) in deucravacitinib-treated patients were nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, rash, headache and diarrhoea. There were no serious AEs and no occurrence of herpes zoster, opportunistic infections and major adverse cardiovascular events, or differences versus placebo in mean changes in laboratory parameters with deucravacitinib treatment.

Conclusions: Treatment with the selective TYK2 inhibitor deucravacitinib was well tolerated and resulted in greater improvements than placebo in ACR-20, multiplicity-controlled secondary endpoints and other exploratory efficacy measures in patients with PsA. Larger trials over longer periods of time with deucravacitinib are warranted to confirm its safety profile and benefits in PsA.

Trial registration number: NCT03881059.

Keywords: arthritis; inflammation; psoriatic; therapeutics.

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Conflict of interest statement

Competing interests: PJM: research grants: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma and UCB; consulting and/or speaker fees: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma and UCB. AAD: consulting and/or advisory boards: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer and UCB; research grants: AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer and UCB. DvdH: consulting fees: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma; Director: Imaging Rheumatology. FB: research grants: Pfizer, Janssen, Chugai, Celgene and Roche; consultancies/speaker fees: Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche, Chugai, Bristol Myers Squibb and UCB Pharma. AJK: shareholder: Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences and Novartis; paid consultant: AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research and Gilead Sciences; speakers bureau: Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion and AbbVie. JN: research grants to foundation: AbbVie, Amgen, Eli Lilly, Genentech, Novartis, UCB, Pfizer, Gilead and Bristol Myers Squibb. SS, MN, SB: employees and shareholders of Bristol Myers Squibb. JK: employee of Bristol Myers Squibb at time of the study conduct.

Figures

Figure 1
Figure 1
ACR-20 response and change in HAQ-DI score over time. Supporting values are shown in online supplemental table S4. (A) Time course of ACR-20 response through week 16. Response rates are reported in the intention-to-treat population (ie, all randomised patients) with non-responder imputation; patients who discontinued the trial early, started a prohibited treatment, were lost to follow-up or had no ACR assessments had outcomes imputed as non-responses. (B) Adjusted mean change from baseline in HAQ-DI score through week 16. Placebo, n=66; deucravacitinib 6 mg once a day, n=70; deucravacitinib 12 mg once a day, n=67. P values indicate a difference from placebo: *p<0.05, **p≤0.01, ***p≤0.001, adjusted for multiplicity at week 16 only. ACR, American College of Rheumatology; HAQ-DI, Health Assessment Questionnaire-Disability Index; QD, once a day.
Figure 2
Figure 2
Laboratory parameters over 16 weeks (mean±SD): (A) lymphocytes, (B) neutrophils, (C) platelets, (D) haemoglobin, (E) total cholesterol and (F) triglycerides. Supporting values are shown in online supplemental table S5. QD, once a day.
See this image and copyright information in PMC

References

    1. Greb JE, Goldminz AM, Elder JT, et al. . Psoriasis. Nat Rev Dis Primers 2016;2:16082. 10.1038/nrdp.2016.82 - DOI - PubMed
    1. Ritchlin CT, Colbert RA, Gladman DD. Psoriatic arthritis. N Engl J Med 2017;376:957–70. 10.1056/NEJMra1505557 - DOI - PubMed
    1. Li C-R, Chen L, Wang L-F, et al. . Association between uveitis and psoriatic disease: a systematic review and meta-analysis based on the evidence from cohort studies. Int J Ophthalmol 2020;13:650–9. 10.18240/ijo.2020.04.19 - DOI - PMC - PubMed
    1. Elalouf O, Muntyanu A, Polachek A, et al. . Mortality in psoriatic arthritis: risk, causes of death, predictors for death. Semin Arthritis Rheum 2020;50:571–5. 10.1016/j.semarthrit.2020.04.001 - DOI - PubMed
    1. Wu JJ, Pelletier C, Ung B, et al. . Treatment switch patterns and healthcare costs in biologic-naive patients with psoriatic arthritis. Adv Ther 2020;37:2098–115. 10.1007/s12325-020-01262-9 - DOI - PMC - PubMed

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