AB0886 The Impact of Deucravacitinib on Health-Related Quality of Life Measured by the Short Form Health Survey 36-Item Questionnaire: Analysis of a Phase 2 Trial in Patients With Active Psoriatic Arthritis

Abstract

Background

Patients (pts) with psoriatic arthritis (PsA) experience pain, loss of physical function, joint damage, and significant impairments in social and emotional well-being. The Short Form Health Survey 36-item questionnaire (SF-36v2), a generic measure of pt-reported health-related quality of life (HRQOL), includes 36 items and measures 8 domains—physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH)—that contribute to both physical component summary (PCS) and mental component summary (MCS) scores. Deucravacitinib (DEUC) is a novel, oral, selective, allosteric inhibitor of tyrosine kinase 2 (TYK2), an intracellular kinase that mediates cytokine signalling pathways implicated in PsA pathogenesis. In a Phase 2 trial in pts with active PsA, DEUC was well tolerated and significantly more efficacious than placebo (PBO) after 16 weeks (wks) of treatment. ¹

Objectives

To further evaluate the effect of DEUC treatment on SF-36 scores.

Methods

This double-blind Phase 2 trial (NCT03881059) enrolled pts with a PsA diagnosis ≥6 months who fulfilled Classification Criteria for Psoriatic Arthritis at screening and had active joint disease (≥3 tender and ≥3 swollen joints), high-sensitivity CRP ≥3 mg/L, and ≥1 plaque psoriasis lesion (≥2 cm). Pts failed or were intolerant to ≥1 nonsteroidal anti-inflammatory, conventional synthetic DMARD, and/or 1 TNF inhibitor (≤30%). Pts were randomised 1:1:1 to DEUC 6 mg once daily (QD) or 12 mg QD, or PBO. Changes from baseline (BL) in SF-36 PCS and MCS scores at Wk 16 were prespecified key secondary and additional endpoints, respectively. The 8 SF-36 domain scores were evaluated at Wk 16. The proportions of pts reporting improvements ≥2.5 and ≥5 points (the minimum clinically important difference [MCID]) in SF-36 summary and domain scores, respectively, were evaluated.

Results

Of 203 pts randomised, 180 (89%) completed 16 wks of treatment (DEUC 6 mg QD, 63/70 [90%]; DEUC 12 mg QD, 59/67 [88%]; PBO, 58/66 [88%]). Demographic and BL disease characteristics were similar across groups. BL mean SF-36 PCS and MCS scores were similar among DEUC 6 mg QD, 12 mg QD, and PBO groups (PCS: 34.0, 34.5, and 33.4; MCS: 45.4, 46.9, and 47.5, respectively). At Wk 16, adjusted mean changes from BL in SF-36 PCS and MCS scores were significantly improved with DEUC 6 and 12 mg QD treatment vs PBO (PCS: 5.6, 5.8, and 2.3; MCS: 3.6, 3.5, and 0.7, respectively; P<0.05). Reported improvements in domain scores with both doses exceeded MCID and were significant in 5 of 8 domains with DEUC 6 mg QD (PF, RP, BP, VT, and SF) and 6 of 8 domains with DEUC 12 mg QD (RE in addition; Figure 1 and Table 1).

Table 1.

Improvements reported in SF-36 domains with deucravacitinib 6 mg QD and 12 mg QD vs placebo at Week 16

	PF	RP	BP	GH	VT	SF	RE	MH
Deucravacitinib 6 mg – BL	41.9	42.9	32.5	39.6	39.0	57.0	69.5	58.4
Deucravacitinib 12 mg – BL	44.1	46.0	33.4	38.5	43.0	65.5	71.5	59.2
Placebo – BL	42.4	42.8	31.7	40.3	38.8	63.8	75.1	59.9
Deucravacitinib 6 mg – LSM Wk 16	14.6	12.3	15.9	9.5	11.7	13.2	6.9	8.1
Deucravacitinib 12 mg – LSM Wk 16	13.3	13.5	19.5	8.4	12.1	10.5	8.7	8.2
Placebo – LSM Wk 16	3.3	5.3	7.0	6.2	4.2	-0.2	1.6	3.6
Protocol A/G norms	81.1	81.9	72.5	70.2	59.1	85.1	88.0	76.2

Domain scores range from 0-100, with higher scores indicating better health status.

A/G, age/gender; BL, baseline; BP, bodily pain; GH, general health; LSM, least square mean change; MH, mental health; PF, physical functioning; QD, once daily; RE, role-emotional; RP-role-physical; SF, social functioning; SF-36, Short Form-36; VT, vitality; Wk, week.

Conclusion

Pts with PsA treated with DEUC reported clinically meaningful and significant improvements in HRQOL, including fatigue, social functioning and role emotional in addition to physical functioning, role physical and pain, at Wk 16.

References

[1]Mease PJ et al. Efficacy and Safety of Selective TYK2 Inhibitor, Deucravacitinib, in a Phase 2 Trial in Psoriatic Arthritis. Ann Rheum Dis. (In Press)

Acknowledgements

The study was sponsored by Bristol Myers Squibb. Professional medical writing assistance from Julianne Hatfield, PhD was provided by Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, USA, and funded by Bristol Myers Squibb.

Disclosure of Interests

Vibeke Strand Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Celltrion, Galapagos, Gilead, Janssen, Lilly, Merck, Novartis, Pfizer, Rheos, Samsung, Sandoz, Sun Pharma, UCB., Philip J Mease Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, UCB, Atul Deodhar Consultant of: Consulting and/or advisory boards: AbbVie, Amgen, Aurinia, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, MoonLake, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, UCB, June Ye Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Miroslawa Nowak Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Jiyoon Choi Shareholder of: Employee of Bristol Myers Squibb at time of study conduct, Employee of: Employee of Bristol Myers Squibb at time of study conduct, Brandon Becker Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb