Background/Purpose

Psoriatic arthritis (PsA) has a significant adverse effect on patients’ health-related quality of life (HRQoL), affecting their physical and emotional functioning and psychological health. Here we present the impact of treatment with secukinumab on patient-reported outcomes (PROs) in patients enrolled in FUTURE 1 (NCT01392326), the first phase 3 trial to evaluate interleukin (IL)-17A inhibition in subjects with PsA.

Methods

Adults with active, moderate to severe PsA were randomized to secukinumab 10 mg/kg i.v. at baseline, Weeks 2 and 4, then either 75 mg s.c. (10 IV → 75 SC; n = 202) or 150 mg s.c. (10 IV → 150 SC; n = 202) at Week 8 and every 4 weeks until end of study, or placebo (PBO; n = 202) on the same i.v. and s.c. schedules. PROs were measured using: Health Assessment Questionnaire – Disability Index (HAQ-DI); Short Form-36 Health Survey (SF-36); EuroQoL (EQ-5D); PsAQoL; Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F); and Work Productivity and Activity Impairment – General Health (WPAI). PROs were reported using a mixed-effect model repeated measures analysis, except WPAI and SF-36 domains which were assessed using an observed analysis.

Results

At baseline, dose groups were comparable with respect to demographics and disease activity; subjects had moderate to severe physical impairment, fatigue levels and impaired HRQOL. Secukinumab 10 IV → 75 SC and 10 IV → 150 SC significantly improved HAQ-DI (P < 0.0001), SF-36 physical component summary [PCS] score (P < 0.0001), EQ-5D (P < 0.001 and P < 0.0001) and PsAQoL (P < 0.0001) vs. PBO at Week 24; only 10 IV → 150 SC significantly improved FACIT-F (P < 0.05). Mean changes from baseline reported in HAQ-DI, PCS, mental component summary (MCS) and all domains of SF-36 and FACIT-F exceeded minimum clinically important differences  (MCID; Table, in bold): physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Various aspects of work productivity, as assessed by WPAI, were also improved with secukinumab vs. PBO. Improvements in all PROs were sustained or further increased over 52 weeks.

Table.  Mean baseline scores and mean change from baseline (BL) in patient-reported outcomes (PROs) at Week 24 by treatment group
PROs		Secukinumab 10 mg/kg i.v. → 75 mg s.c. n = 202	Secukinumab  10 mg/kg i.v. → 150 mg s.c. n = 202	Placebo n = 202
HAQ-DIa (MCID ≥ 0.35)	BL   Change from BL at  Week 24	1.25 –0.41*	1.23 –0.40*	1.19 –0.17
EQ-5D (VAS)b	BL   Change from BL at  Week 24	52.80 11.91ǂ	52.60 13.36*	52.60 2.45
PsAQoLa	BL   Change from BL at  Week 24	10.65 –3.19*	10.27 –3.49*	10.65 –0.36
FACIT-Fatigueb (MCID ≥ 4)	BL   Change from BL at  Week 24	27.59 6.03	28.90 6.74†	27.82 4.0
SF-36 PCSb (MCID ≥ 2.5)	BL   Change from BL at  Week 24	36.90 5.41*	36.16 5.91*	36.63 1.82
SF-36 MCSb (MCID ≥ 2.5)	BL   Change from BL at  Week 24	42.04 3.67	42.82 5.66§	43.49 2.39
SF-36 Domainsc (MCID ≥ 5)
PF	BL Change from BL at  Week 24c	45.66 14.23	42.62 15.73	46.94 7.08
RP	BL Change from BL at  Week 24c	47.32 13.68	45.99 18.52	47.01 9.27
BP	BL Change from BL at  Week 24c	36.47 18.68	36.01 19.78	36.84 12.92
GH	BL Change from BL at  Week 24c	40.91 8.81	42.42 12.03	41.72 6.33
VT	BL Change from BL at  Week 24c	39.31 12.32	41.31 13.86	41.94 9.62
SF	BL Change from BL at  Week 24c	56.71 13.80	56.15 17.41	57.81 10.53
RE	BL Change from BL at  Week 24c	58.29 9.73	56.93 14.30	58.24 5.68
MH	BL Change from BL at  Week 24c	56.28 8.25	58.97 10.35	61.09 5.60

*P < 0.0001, ǂP < 0.001, §P < 0.01, †P < 0.05 vs. PBO aDecrease in score represents improvement; bIncrease in score represents improvement; cObserved data with no statistical analysis performed (n = 192, 191 and 184 for secukinumab 10 mg/kg i.v. →75 mg s.c., secukinumab 10 mg/kg i.v. →150 mg s.c. and PBO, respectively, for BP, GH, MH, PF, SF and VT assessments; n = 191, 190 and 182, respectively, for other SF-36 domains [RE and RP]). P-values are from a mixed model repeated measures analysis. BP, bodily pain; EQ-5D (VAS), EuroQoL health questionnaire (visual analogue scale); GH, general health; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy – Fatigue; HAQ-DI, Health Assessment Questionnaire – Disability Index; i.v., intravenous; MCID, minimum clinically important difference; MH, mental health; PsAQoL, psoriatic arthritis quality of life questionnaire; PF, physical functioning; RE, role emotional; RP, role physical; s.c., subcutaneous; SF, social functioning; SF-36 MCS, short form-36 health survey – mental component summary; SF-36 PCS, short form-36 health survey – physical component summary; VT, vitality.

 

Conclusion

In patients with active PsA, selective inhibition of IL-17A with secukinumab improved physical function (HAQ-DI), fatigue (FACIT), and HRQOL by generic (SF-36, EQ-5D) and disease-specific (PsAQoL) measures, and reduced the impact of disease on work productivity (WPAI).

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/secukinumab-an-anti-interleukin-17a-monoclonal-antibody-improves-physical-function-quality-of-life-and-work-productivity-in-patients-with-active-psoriatic-arthritis-results-from-a-phase-3/