| Literature DB >> 33052584 |
Ana-Maria Orbai1, Julie A Birt2, Elizabeth A Holdsworth3, Nicola Booth3, William N Malatestinic4, Aubrey T Sprabery4, Anthony M Reginato5.
Abstract
INTRODUCTION: Enthesitis is a core outcome domain assessed in psoriatic arthritis (PsA) clinical trials. Limited evidence describes the impact of enthesitis on patient-reported outcomes (PROs) and physician satisfaction with current treatment options. The objective of this analysis is to characterize the impact of enthesitis on PROs and physician satisfaction with currently available treatment in clinical practice settings.Entities:
Keywords: PROs; Patient-reported outcome; Psoriatic arthritis; Real-world evidence; Satisfaction
Year: 2020 PMID: 33052584 PMCID: PMC7695789 DOI: 10.1007/s40744-020-00242-3
Source DB: PubMed Journal: Rheumatol Ther ISSN: 2198-6576
Baseline demographics in patients with and without enthesitis
| Overall (3157) | With enthesitis (205) | Without enthesitis (2952) | |
|---|---|---|---|
| Age, mean (SD) | 49.2 (13.3) | 50.7 (13.4) | 49.0 (13.3) |
| Sex, | 1448 (45.9) | 93 (45.4) | 1355 (45.9) |
| BMI, mean (SD) | 26.9 (6.5) | 27.2 (5.6) | 26.8 (6.5) |
| Employment status, | 3028 | 199 | 2829 |
| Working full time | 1739 (57.4) | 94 (47.2) | 1645 (58.1) |
| Working part time | 353 (11.7) | 30 (15.1) | 323 (11.4) |
| On long-term sick leave | 74 (2.4) | 15 (7.5) | 59 (2.1) |
| Unemployed | 151 (5.0) | 6 (3.0) | 145 (5.1) |
| Other* | 711 (23.5) | 54 (27.1) | 657 (23.2) |
| Time since diagnosis, mean (SD) years [ | 4.9 (6.0) [2467] | 4.6 (5.6) [179] | 5.0 (6.0) [2288] |
BMI body mass index, n number of patients in a subgroup, SD standard deviation
*“Other” includes homemaker, student, retired
Physician-reported clinical characteristics of patients stratified according to “with current enthesitis” and “without current enthesitis”
| Overall (3157) | With enthesitis (205) | Without enthesitis (2952) | ||
|---|---|---|---|---|
| Physician-rated disease severity, | ||||
| Mild | 2364 (74.9) | 98 (47.8) | 2266 (76.8) | < 0.0001 |
| Moderate | 702 (22.2) | 82 (40.0) | 620 (21.0) | |
| Severe | 91 (2.9) | 25 (12.2) | 66 (2.2) | |
| Additional manifestations present, | ||||
| Nail psoriasis | 506 (16.0) | 68 (33.2) | 438 (14.8) | < 0.0001 |
| Dactylitis | 238 (7.5) | 65 (31.7) | 173 (5.9) | < 0.0001 |
| Uveitis | 25 (0.8) | 2 (1.0) | 23 (0.8) | 0.6754 |
| Inflammatory bowel disease | 46 (1.5) | 4 (2.0) | 42 (1.4) | 0.5386 |
| Sacroiliitis | 121 (3.8) | 22 (10.7) | 99 (3.4) | < 0.0001 |
| Inflammatory back pain | 305 (9.7) | 38 (18.5) | 267 (9.0) | < 0.0001 |
| Number of joints affected by PsA, mean (SD) | 3.18 (4.51) | 6.13 (6.95) | 2.98 (4.22) | < 0.0001 |
| 68 TJC, mean (SD) [ | 3.89 (6.34) [697] | 7.76 (11.66) [59] | 3.53 (5.48) [638] | < 0.0001 |
| 66 SJC, mean (SD) [ | 3.28 (6.93) [742] | 6.33 (10.08) [60] | 3.01 (6.53) [682] | 0.0004 |
| DAS28 mean (SD) [ | 2.32 (1.56) [326] | 3.74 (1.58) [22] | 2.22 (1.51) [304] | < 0.0001 |
| Current psoriasis BSA, mean (SD) [ | 6.0 (9.7) [2665] | 7.3 (10.6) [165] | 5.9 (9.6) [2500] | 0.0764 |
| BSA 0–3% | 1614 (60.6) | 91 (55.2) | 1523 (60.9) | |
| BSA > 3–10% | 568 (21.3) | 34 (20.6) | 534 (21.4) | |
| BSA > 10% | 483 (18.1) | 40 (24.2) | 443 (17.7) | |
BSA body surface area, DAS28 disease activity score in 28 joints, PsA psoriatic arthritis, SD standard deviation, SJC swollen joint count, TJC tender joint count
ap values indicate comparison between “with enthesitis” and “without enthesitis” groups. Mann–Whitney test used for comparing physician rated disease severity, number of joints affected, TJC, SJC, DAS28; Fisher’s exact test used for comparing additional manifestations. Student t test used for comparing mean BSA
Fig. 1PsAID12 score by enthesitis presence (mean). *Student’s t test was used to compare outcomes from “with enthesitis” and “without enthesitis” groups. PsAID12 Psoriatic Arthritis Impact of Disease, QoL quality of life
Fig. 2EQ5D utility score by enthesitis presence (mean). *Student’s t test was used to compare outcomes from “with enthesitis” and “without enthesitis” groups. QoL quality of life
Fig. 3Work productivity and activity impairment by enthesitis presence. *Student’s t test was used to compare outcomes from “with enthesitis” and “without enthesitis” groups
Treatment types received
| Overall (1382) | With enthesitis (90) | Without enthesitis (1292) | ||
|---|---|---|---|---|
| Current treatment types, pain medication, | 3157 | 205 | 2952 | |
| NSAID | 768 (24.3) | 91 (44.4) | 677 (22.9) | < 0.0001 |
| Non-opioid analgesic | 182 (5.8) | 22 (10.7) | 160 (5.4) | 0.0045 |
| Opioid analgesic | 74 (2.3) | 17 (8.3) | 57 (1.9) | < 0.0001 |
| Current treatment types, DMARD, | ||||
| tsDMARD | 300 (9.5) | 25 (12.2) | 275 (9.3) | 0.1754 |
| Biologic DMARD | 1844 (58.4) | 120 (58.5) | 1724 (58.4) | 1.0000 |
| csDMARD | 1102 (34.9) | 92 (44.9) | 1010 (34.2) | 0.0024 |
NSAID non-steroidal anti-inflammatory drug, n number of patients in a subgroup, tsDMARD targeted synthetic DMARD (apremilast or tofacitinib), csDMARD conventional systemic DMARD, DMARD disease-modifying anti-rheumatic drug
ap values indicate comparison between “with enthesitis” and “without enthesitis” groups. Comparison was made with Fisher’s exact test
Physician satisfaction with current therapy
| Overall (1382) | With enthesitis (90) | Without enthesitis (1292) | ||
|---|---|---|---|---|
| Physician satisfaction with current treatment, | (3157) | (205) | (2952) | |
| Very satisfied | 1128 (35.7) | 25 (12.2) | 1103 (37.4) | < 0.0001 |
| Satisfied | 1479 (46.8) | 93 (45.4) | 1386 (47.0) | |
| Neither satisfied nor dissatisfied | 401 (12.7) | 57 (27.8) | 344 (11.7) | |
| Dissatisfied | 124 (3.9) | 25 (12.2) | 99 (3.4) | |
| Very dissatisfied | 25 (0.8) | 5 (2.4) | 20 (0.7) |
ap values indicate comparison between “with enthesitis” and “without enthesitis” groups. Comparison made with Mann–Whitney test
| Enthesitis is a core outcome domain assessed in psoriatic arthritis (PsA) clinical trials. |
| Limited evidence describes the impact of enthesitis on patient-reported outcomes (PROs) and physician satisfaction with current treatment options. |
| The objective of this real-world cross-sectional study was to characterize the impact PsA enthesitis had on PROs and to explore the contribution of enthesitis to physician-reported satisfaction with their patients’ treatment. |
| Patients with enthesitis had worse overall disease severity, more extraarticular manifestations, more pain and opioid use, worse quality of life (QoL), and physicians were significantly less satisfied with current PsA treatment compared to patients without enthesitis. |
| Our findings underscore the importance of assessing patients with PsA for enthesitis and ensuring its optimal management. Data on PsA treatment efficacy specifically for enthesitis are needed to expand treatment options for patients and physicians. |