Achieving Increasingly Stringent Clinical Disease Control Criteria Is Associated with Greater Improvements in Patient-Centric Measures of Physical Function and Pain in Patients with Active PsA: 16-Week Results from Two Phase 3 Randomized, Placebo-Controlled Studies

No Thumbnail Available
File version
Author(s)
Walsh, Jessica
Coates, Laura
Mease, Philip J
Merola, Joseph
Nash, Peter
Ogdie, Alexis
Tillett, William
Gisondi, Paolo
Ink, Barbara
Assudani, Deepak
Bajracharya, Rajan
Lambert, Jeremy
Taieb, Vanessa
Willems, Damon
Erik, Lars
Griffith University Author(s)
Primary Supervisor
Other Supervisors
Editor(s)
Date
2022
Size
File type(s)
Location
Philadelphia, USA
License
Abstract

Background/Purpose: Examine the association between achieving increasingly stringent clinical disease control criteria and patient-centric measures of physical function and pain in patients with PsA, using data from BE OPTIMAL and BE COMPLETE.

Methods: BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) were phase 3 studies of bimekizumab (BKZ) in patients with active PsA who were bDMARD-naïve or had inadequate response to a tumor necrosis factor inhibitor (TNFi-IR), respectively; BE OPTIMAL included an additional adalimumab reference arm. In this post hoc analysis, all patients who reached specified disease control criteria (ACR: < 20% improvement from baseline, ≥20%–< 50%, ≥50%–< 70%, ≥70%; minimal Disease Activity (MDA): non-MDA, MDA; Disease Activity in Psoriatic Arthritis (DAPSA): high disease activity (HDA), moderate disease activity (MoDA), low disease activity/remission (LDA/REM); Psoriasis Area and Severity Index (PASI): < 50% improvement from baseline, ≥50%–< 75%, ≥75%–< 90%, ≥90%) at Wk 16 were pooled regardless of treatment arm, by study. Associations between achievement of these specified disease control criteria and improvements in patient-reported measures of physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]: scored from 0 [best] to 3 [worst]) and pain (Patient’s Assessment of Arthritis Pain (PtAAP): 0 [best] to 100 [worst]) were assessed; it should be noted that some aspects of these clinical disease control criteria relate to aspects of HAQ-DI and PtAAP. Observed case data reported.

Results: The majority of patients completed Wk 16 of each study (bDMARD-naïve: 821/852 [96.4%]; TNFi-IR: 388/400 [97.0%]). Patients achieving higher ACR response thresholds demonstrated sequentially greater mean (95% CI) improvements from baseline in HAQ-DI (bDMARD-naïve: < ACR20: −0.02 [−0.06, 0.02], ACR20–< ACR50: −0.22 [−0.28, −0.15], ACR50–< ACR70: −0.42 [−0.49, −0.35], ACR70: −0.53 [−0.60, −0.45]; TNFi-IR: −0.08 [−0.14, −0.01], −0.32 [−0.40, −0.24], −0.39 [−0.49, −0.29], −0.69 [−0.79, −0.58]; Figure 1A) and PtAAP scores (bDMARD-naïve: < ACR20: −0.1 [−2.3, 2.0], ACR20–< ACR50: −21.1 [−24.0, −18.1], ACR50–< ACR70: −33.8 [−37.6, −30.0], ACR70: −48.5 [−52.1, −44.9]; TNFi-IR: −2.7 [−5.9, 0.5], −23.9 [−28.2, −19.5], −37.4 [−43.0, −31.8], −50.5 [−56.3, −44.8]; Figure 1B) in both studies. Similar results were seen with MDA and DAPSA (Figure 1). Patients achieving ≥PASI50 also exhibited greater improvements versus the < PASI50 group in both studies (Figure 1).

Conclusion: Patients with active PsA who achieved increasingly stringent disease control criteria at Wk 16, as evaluated by clinicians, reported greater improvements in their HAQ-DI (physical function) and PtAAP (pain) scores, regardless of whether they were bDMARD-naïve (BE OPTIMAL) or TNFi-IR (BE COMPLETE).

Journal Title
Conference Title
Arthritis & Rheumatology
Book Title
Edition
Volume
74
Issue
S9
Thesis Type
Degree Program
School
DOI
Patent number
Funder(s)
Grant identifier(s)
Rights Statement
Rights Statement
Item Access Status
Note
Access the data
Related item(s)
Subject
Clinical sciences
Public health
Life Sciences & Biomedicine
Rheumatology
Science & Technology
Persistent link to this record
Citation
Walsh, J; Coates, L; Mease, PJ; Merola, J; Nash, P; Ogdie, A; Tillett, W; Gisondi, P; Ink, B; Assudani, D; Bajracharya, R; Lambert, J; Taieb, V; Willems, D; Erik, L, Achieving Increasingly Stringent Clinical Disease Control Criteria Is Associated with Greater Improvements in Patient-Centric Measures of Physical Function and Pain in Patients with Active PsA: 16-Week Results from Two Phase 3 Randomized, Placebo-Controlled Studies, Arthritis & Rheumatology, 2022, 74 (S9), pp. 4194-4196