Achieving Stringent Clinical Disease Control Criteria Is Associated With Improved Quality of Life Measures in Patients With Active Psoriatic Arthritis: Results From Two Phase 3 Randomised, Placebo-Controlled Studies
Author(s)
Kristensen, LE
Coates, LC
Mease, PJ
Nash, P
Ogdie, AR
Tillett, W
Gisondi, P
Ink, B
Prickett, AR
Assudani, D
Bajracharya, R
Taieb, V
Willems, D
Lambert, J
Walsh, JA
Griffith University Author(s)
Year published
2022
Metadata
Show full item recordAbstract
Objectives
To examine the association between achieving stringent clinical disease control and quality of life (QoL) improvements in patients with psoriatic arthritis (PsA).
Methods
Post hoc analysis of Week 16 results from bimekizumab phase 3 studies, BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [bDMARD]-naïve patients) and BE COMPLETE (NCT03896581; inadequate response/intolerance to TNF inhibitors [TNFi-IR]).1,2 Patients achieving disease control criteria (American College of Rheumatology [ACR]: <20% improvement from baseline, ≥20% to <50%, ≥50% to <70%, ≥70%; minimal disease activity [MDA]; ...
View more >Objectives To examine the association between achieving stringent clinical disease control and quality of life (QoL) improvements in patients with psoriatic arthritis (PsA). Methods Post hoc analysis of Week 16 results from bimekizumab phase 3 studies, BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [bDMARD]-naïve patients) and BE COMPLETE (NCT03896581; inadequate response/intolerance to TNF inhibitors [TNFi-IR]).1,2 Patients achieving disease control criteria (American College of Rheumatology [ACR]: <20% improvement from baseline, ≥20% to <50%, ≥50% to <70%, ≥70%; minimal disease activity [MDA]; Psoriatic Arthritis Response Criteria [PsARC]) at Week 16 were pooled regardless of treatment arm, by study. The association between achieving these criteria and mean changes from baseline in QoL measures (EQ-5D-3L VAS, EQ-5D-3L utility [UK tariff] and SF-36 PCS) was assessed (observed case). Results 821/852 (96.4%) bDMARD-naïve, 388/400 (97.0%) TNFi-IR patients completed Week 16. Baseline mean (SD) EQ-5D-3L VAS, EQ-5D-3L utility and SF-36 PCS (bDMARD-naïve/TNFi-IR) scores: 56.3 (20.0)/54.4 (20.4), 0.63 (0.23)/0.56 (0.27) and 37.6 (9.4)/36.3 (9.4). Patients achieving greater ACR responses demonstrated greater mean (95% CI) improvements in EQ-5D-3L VAS (bDMARD-naïve: <20%: −1.2 [−3.3, 0.9], ≥20%<50%: 11.0 [7.7, 14.3], ≥50%<70%: 14.0 [10.1, 17.9], ≥70%: 23.7 [19.7, 27.7]; TNFi-IR: 0.5 [−2.7, 3.8], 9.3 [4.9, 13.8], 11.7 [5.3, 18.1], 29.5 [23.0, 35.9]). MDA responders showed greater mean (95% CI) improvements in EQ-5D-3L VAS versus non-responders (bDMARD-naïve: non-responders 2.9 [1.1, 4.8] versus responders 17.5 [14.7, 20.3]; TNFi-IR: 3.5 [0.8, 6.1] versus 20.9 [16.0, 25.8]). Greater mean (95% CI) EQ-5D-3L VAS improvements were also demonstrated in PsARC responders versus non-responders (bDMARD-naïve: −1.6 [−4.3, 1.0] versus 12.3 [10.3, 14.2]; TNFi-IR: −2.1 [−6.3, 2.2] versus 14.1 [11.2, 17.1]). The trends were similar for EQ-5D-3L utility and SF-36 PCS. Conclusions Patients with PsA achieving stringent disease control demonstrated greater improvements in QoL at Week 16.
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View more >Objectives To examine the association between achieving stringent clinical disease control and quality of life (QoL) improvements in patients with psoriatic arthritis (PsA). Methods Post hoc analysis of Week 16 results from bimekizumab phase 3 studies, BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [bDMARD]-naïve patients) and BE COMPLETE (NCT03896581; inadequate response/intolerance to TNF inhibitors [TNFi-IR]).1,2 Patients achieving disease control criteria (American College of Rheumatology [ACR]: <20% improvement from baseline, ≥20% to <50%, ≥50% to <70%, ≥70%; minimal disease activity [MDA]; Psoriatic Arthritis Response Criteria [PsARC]) at Week 16 were pooled regardless of treatment arm, by study. The association between achieving these criteria and mean changes from baseline in QoL measures (EQ-5D-3L VAS, EQ-5D-3L utility [UK tariff] and SF-36 PCS) was assessed (observed case). Results 821/852 (96.4%) bDMARD-naïve, 388/400 (97.0%) TNFi-IR patients completed Week 16. Baseline mean (SD) EQ-5D-3L VAS, EQ-5D-3L utility and SF-36 PCS (bDMARD-naïve/TNFi-IR) scores: 56.3 (20.0)/54.4 (20.4), 0.63 (0.23)/0.56 (0.27) and 37.6 (9.4)/36.3 (9.4). Patients achieving greater ACR responses demonstrated greater mean (95% CI) improvements in EQ-5D-3L VAS (bDMARD-naïve: <20%: −1.2 [−3.3, 0.9], ≥20%<50%: 11.0 [7.7, 14.3], ≥50%<70%: 14.0 [10.1, 17.9], ≥70%: 23.7 [19.7, 27.7]; TNFi-IR: 0.5 [−2.7, 3.8], 9.3 [4.9, 13.8], 11.7 [5.3, 18.1], 29.5 [23.0, 35.9]). MDA responders showed greater mean (95% CI) improvements in EQ-5D-3L VAS versus non-responders (bDMARD-naïve: non-responders 2.9 [1.1, 4.8] versus responders 17.5 [14.7, 20.3]; TNFi-IR: 3.5 [0.8, 6.1] versus 20.9 [16.0, 25.8]). Greater mean (95% CI) EQ-5D-3L VAS improvements were also demonstrated in PsARC responders versus non-responders (bDMARD-naïve: −1.6 [−4.3, 1.0] versus 12.3 [10.3, 14.2]; TNFi-IR: −2.1 [−6.3, 2.2] versus 14.1 [11.2, 17.1]). The trends were similar for EQ-5D-3L utility and SF-36 PCS. Conclusions Patients with PsA achieving stringent disease control demonstrated greater improvements in QoL at Week 16.
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Journal Title
Value in Health
Conference Title
ISPOR Europe 2022
Volume
25
Issue
12
Subject
Rheumatology and arthritis
Immunology
Social Sciences
Science & Technology
Life Sciences & Biomedicine
Economics
Health Care Sciences & Services