Effectiveness and Safety of Deucravacitinib for the Management of Psoriasis: A Review of the Current Literature

Figures & data

Figure 1 PRISMA flowchart of study analysis.

Notes: PRISMA figure adapted from Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. Creative Commons.²¹

Table 1 Effectiveness of Deucravacitinib for Psoriasis Management in Clinical Trials

Author	Study Phase/Period	Patients	Study Group	Efficacy
				PASI75 n (%)	PASI90 n (%)	PASI100 n (%)	sPGA 0/1 n (%)
Papp et al^Citation22	Phase2 12w	267	Placebo: 45 Deucravacitinib:  3mg QAD: 44  3mg QD: 44  3mg BID: 45  6mg BID: 45  12mg QD: 44	Placebo: 3 (6.7) Deucravacitinib:  3mg QAD: 4 (9.1)  3mg QD: 17 (38.6)  3mg BID: 31 (68.9)  6mg BID: 30 (66.7)  12mg QD: 33 (75.0)	Placebo: 1 (2.2) Deucravacitinib:  3mg QAD: 3 (6.8)  3mg QD: 7 (15.9)  3mg BID: 20 (44.4)  6mg BID: 20 (44.4)  12mg QD: 19 (43.2)	Placebo: 0 Deucravacitinib:  3mg QAD: 1 (2.3)  3mg QD: 0  3mg BID: 4 (8.9)  6mg BID: 8 (17.8)  12mg QD: 11 (25.0)	Placebo: 3 (6.7) Deucravacitinib:  3mg QAD: 9 (20.5)  3mg QD: 17 (38.6)  3mg BID: 34 (75.6)  6mg BID: 29 (64.4)  12mg QD: 33 (75.0)
Armstrong et al^Citation24*	Phase3 52w*	666	Placebo: 166 Deucravacitinib 6mg QD: 332 Apremilast 30mg BID: 168	Placebo: 21 (12.7) Deucravacitinib: 194 (58.4) Apremilast: 59 (35.1)	Placebo: 7 (4.2) Deucravacitinib: 118 (35.5) Apremilast: 33 (19.6)	Placebo: 1 (0.6) Deucravacitinib: 47 (14.2) Apremilast: 5 (3.0)	Placebo: 12 (7.2) Deucravacitinib: 178 (53.6) Apremilast: 54 (32.1)
Strober et al^Citation25*	Phase3 52w*	1020	Placebo: 255 Deucravacitinib 6mg QD: 511 Apremilast 30mg BID: 254	Placebo: 24 (9.4) Deucravacitinib: 271 (53.0) Apremilast: 101 (39.8)	Placebo: 7 (2.7) Deucravacitinib: 138 (27.0) Apremilast: 46 (18.1)	Placebo: 3 (1.2) Deucravacitinib: 52 (10.2) Apremilast: 11 (4.3)	Placebo: 22 (8.6) Deucravacitinib: 253 (49.5) Apremilast: 86 (33.9)

Note: *Results at week 16 before rerandomization or treatment cross over.

Abbreviations: W, week; QAD, every other day; QD, once a day; BID, two times a day; PASI, Psoriasis Area Severity Index; PASI75, PASI reduction of at least 75%; PASI90, PASI reduction of at least 90%; PASI100, PASI reduction of 100; sPGA 0/1, static Physician’s Global Assessment 0/1.

Table 2 Safety of Deucravacitinib for Psoriasis Management in Clinical Trials

Author	Study Group	Any AEs n (%)	Serious AEs n (%)	Treatment-Related AEs n (%)	AEs Leading to Discontinuation n (%)	Most Common AEs n (%)
Papp et al^Citation22	Placebo: 45 Deucravacitinib:  3mg QAD: 44  3mg QD: 44  3mg BID: 45  6mg BID: 45  12mg QD: 44	AEs were collected in 51% of the subjects in the placebo cohort and 55 to 80% patients in the deucravacitinib groups, with the highest percentage in the 6mg BID dose.	Placebo: 1 (2.2) Deucravacitinib:  3mg QAD: 1 (2.3)  3mg QD: 1 (2.3)  3mg BID: 1 (2.2)  6mg BID: 0  12mg QD: 0	NR	Placebo: 2 (4.4) Deucravacitinib:  3mg QAD: 1 (2.3)  3mg QD: 2 (4.5)  3mg BID: 1 (2.2)  6mg BID: 3 (6.7)  12mg QD: 1 (2.3)	Nasopharyngitis, headache, diarrhea, nausea, and URTI were the most common AEs.
Armstrong et al^Citation24*	Placebo: 166 Deucravacitinib 6mg QD: 332 Apremilast 30mg BID: 168	Placebo: 70 (42.4) Deucravacitinib: 176 (53.0) Apremilast:93 (55.4)	Placebo: 9 (5.5) Deucravacitinib: 7 (2.1) Apremilast: 4 (2.4)	Placebo: 20 (12.1) Deucravacitinib: 65 (19.6) Apremilast: 36 (21.4)	Placebo: 7 (4.2) Deucravacitinib: 6 (1.8) Apremilast:10 (6.0)	Placebo: nasopharyngitis (7, 4.2%) – URTI and diarrhea (6, 3.6%) – headache (5, 3.0%) Deucravacitinib: nasopharyngitis and URTI (21, 6.3%) – headache (16, 4.8%) – diarrhea (13, 3.9%) Apremilast: nausea (19, 11.3%) – headache and diarrhea (17, 10.1%) – nasopharyngitis (14, 8.3%)
Strober et al^Citation25*	Placebo: 255 Deucravacitinib 6mg QD: 511 Apremilast 30mg BID: 254	Placebo: 138 (54.3) Deucravacitinib: 293 (57.5) Apremilast: 150 (59.1)	Placebo: 3 (1.2) Deucravacitinib: 8 (1.6) Apremilast: 1 (0.4)	Placebo: 45 (17.7) Deucravacitinib: 99 (19.4) Apremilast: 73 (28.7)	Placebo: 9 (3.5) Deucravacitinib: 14 (2.7) Apremilast: 12 (4.7)	Placebo: nasopharyngitis (29, 11.4%) – diarrhea (19, 7.5%) – headache (14, 5.5%) Deucravacitinib: nasopharyngitis (55, 10.8%) – URTI (25, 4.9%) – diarrhea (24, 4.7%) Apremilast: diarrhea (33, 13.0%) – headache (28, 11.0%) – nasopharyngitis and nausea (23, 9.1%)

Note: *Results at week 16 before rerandomization or treatment cross over.

Abbreviations: AEs, Adverse Events; QAD, every other day; QD, once a day; BID, two times a day; PASI, Psoriasis Area Severity Index; URTI, upper respiratory tract infection.

Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71

 PubMed Web of Science ®Google Scholar

Papp K, Gordon K, Thaçi D, et al. Phase 2 trial of selective tyrosine kinase 2 inhibition in psoriasis. N Engl J Med. 2018;379(14):1313–1321. doi:10.1056/NEJMoa1806382

 PubMed Web of Science ®Google Scholar

Armstrong AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023;88(1):29–39. doi:10.1016/j.jaad.2022.07.002

 PubMed Web of Science ®Google Scholar

Strober B, Thaçi D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 program for evaluation of TYK2 inhibitor psoriasis second trial. J Am Acad Dermatol. 2023;88(1):40–51. doi:10.1016/j.jaad.2022.08.061

 PubMed Web of Science ®Google Scholar