Session Information
Date: Sunday, November 8, 2015
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: To assess the relationship between improvement or worsening in
enthesopathy and changes in functioning and quality of life (QOL) in patients
with psoriatic arthritis (PsA).
Methods:
Adult PsA patients (n=615) with active disease (≥5 SJC and ≥5
TJC;CRP≥0.3mg/dL) despite DMARD and/or NSAIDs were randomized to UST45mg,
90mg, or PBO at weeks 0, 4, and q12weeks. Patients treated with prior anti-TNF
agents were excluded. Stable concomitant MTX was permitted but not mandated. At
week16, pts with <5% improvement in TJC & SJC entered blinded early
escape (PBO→UST45mg; UST45mg→90mg; 90mg→90mg). Presence or absence of enthesopathy, HAQ and SF-36 were
assessed at baseline and week 24. In this post-hoc analysis, the enthesopathy was
focused on the Achilles tendon and plantar fascia and was assessed as present
or absent. Patients were categorized for enthesopathy into three categories:
improved (enthesopathy present at baseline, but not at week 24), worsened
(enthesopathy present at week 24, but not at baseline), and unchanged.
Patients with an enthesopathy assessment missing at either time point were
included in the unchanged category. Improvements in quality of life (assessed
by the Short Form-36 mental and physical component scores [SF-36 PCS and SF-36
MCS] and physical function (assessed by the Health Assessment
Questionnaire-Disability Index [HAQ-DI]) were assessed by enthesopathy status.
Results: 80% of patients (n=491) reported enthesitis at baseline, and the
proportion of patients with enthesopathy was similar in the combined ustekinumab
(47.2%) and placebo (52.1%) groups. At week 24, the proportions of patients
with enthesopathy were 23.2% and 38.2% for the combined ustekinumab and placebo
groups, respectively. Across all
patients, those who had an improvement in enthesopathy had a greater
improvement in functioning and QOL, compared with those who did not (Table). The
results were consistent when the analysis was done separately for each
treatment group. Even when the analysis was restricted to those who achieved
an ACR 20 response, patients with an improvement in enthesopathy still showed a
greater improvement in functioning and QOL compared to those who did not
(Table).
Table Enthesopathy
status and mean (SD) changes from baseline at week 24
|
Enthesopathy Status |
|||
|
|
Worsened |
Unchanged |
Improved |
|
Overall |
|||
|
% improvement in HAQ-DI |
n=21 17.7(35.9) |
n=339 22.6(66.0) |
n=113 37.5(47.0) |
|
Change in SF-36 PCS |
n=22 4.1(7.1) |
n=333 4.9(8.7) |
n=116 6.7(9.1) |
|
Change in SF-36 MCS |
n=22 -1.5(8.8) |
n=333 3.5(10.1) |
n=116 6.7(9.6) |
|
ACR 20 responders |
|||
|
% improvement in HAQ-DI
|
n=8 33.7(32.8) |
n=145 52.8(37.0) |
n=72 53.4(39.1) |
|
Change in SF-36 PCS |
n=8 8.7(7.4) |
n=150 8.7 (8.8) |
n=72 9.5(8.8) |
|
Change in SF-36 MCS |
n=8 3.5(8.0) |
n=150 5.2(10.2) |
n=72 7.7(9.4) |
Conclusion: Ustekinumab treatment can significantly
improve enthesopathy associated with psoriatic arthritis.There is an
association between improvement in enthesopathy of the Achilles tendon and
plantar fascia and improvement in physical function and quality of life in
patients with PsA.
To cite this abstract in AMA style:
Kavanaugh A, Puig L, Gottlieb AB, Ritchlin CT, You Y, Li S, Song M, Rahman P, McInnes IB. Association Between Improvement in Enthesopathy and Quality of Life: Results from a Phase 3 T in Psoriatic Arthritis Patients [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/association-between-improvement-in-enthesopathy-and-quality-of-life-results-from-a-phase-3-t-in-psoriatic-arthritis-patients/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/association-between-improvement-in-enthesopathy-and-quality-of-life-results-from-a-phase-3-t-in-psoriatic-arthritis-patients/