| Literature DB >> 22258482 |
Vibeke Strand1, Veronika Sharp, Andrew S Koenig, Grace Park, Yifei Shi, Brian Wang, Debra J Zack, David Fiorentino.
Abstract
OBJECTIVES: To compare health-related quality of life (HRQoL) before and after treatment with etanercept in patients with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA) and psoriasis using spydergram representations.Entities:
Mesh:
Substances:
Year: 2012 PMID: 22258482 PMCID: PMC3375587 DOI: 10.1136/annrheumdis-2011-200387
Source DB: PubMed Journal: Ann Rheum Dis ISSN: 0003-4967 Impact factor: 19.103
Patient demographics and disease characteristics at baseline
| RA (N = 528) | PsA (N = 205) | Psoriasis (N=583) | |
|---|---|---|---|
| Sex, n (%) | |||
| Men | 141 (27) | 105 (51) | 382 (66) |
| Women | 387 (73) | 100 (49) | 201 (34) |
| Age, mean years (SD) | 51.4 (0.6) | 47.4 (11.1) | 45.2 (11.9) |
| Range | 18–84 | 18–76 | 18–87 |
| Race/ethnicity, n (%) | |||
| White | 463 (88) | 186 (91) | 528 (91) |
| Black/African-American | 6 (1) | 5 (2) | 8 (1) |
| Hispanic/Latino | 27 (5) | 11 (5) | 19 (3) |
| Other | 32 (6) | 3 (2) | 28 (5) |
| Disease duration, mean | |||
| RA | 9.0 mos | – | – |
| PsA | – | 9.1 yrs | – |
| Psoriasis | – | 19.0 yrs | 20.5 yrs |
| Previous therapies | |||
| n (%) DMARD | 113 (21) | 156 (76) | – |
| Psoriasis therapies | – | 147 (72) | 516 (89) |
| Disease characteristics | |||
| Tender joint count, mean no (SD) | 25.0 (14.5) | 21.3 (14.3) | – |
| Swollen joint count, mean no (SD) | 17.3 (10.2) | 15.6 (10.6) | – |
| PASI score, | – | 10.4 (10.7) | 19.1 (8.5) |
| Psoriasis-affected BSA, mean % (SD) | – | 10.6 (15.4) | 28.0 (17.4) |
| Patient-reported outcomes | |||
| HAQ, | 1.7 (0.7) | 1.1 (0.6) | – |
| DLQI, | – | – | 11.7 (6.8) |
Data represent mean (standard error) for patients with RA.
71 possible joints.
78 possible joints.
68 possible joints.
76 possible joints.
PASI scores range from 0 (no psoriasis) to 72 (severe disease).
PASI scores were only collected from psoriasis patients with affected BSA ≥3% (n=128).
HAQ scores range from 0 to 3.
DLQI scores range from 0 (no effect on patient's life) to 30 (extremely large effect on patient's life).
BSA, body surface area; DLQI, dermatology life quality index; DMARD, disease-modifying antirheumatic drug; HAQ, health assessment questionnaire; PASI, psoriasis area and severity index; PsA, psoriatic arthritis; RA, rheumatoid arthritis.
Mean baseline and post-treatment SF-36 PCS and MCS scores and SF-6D scores across trials
| RA | PsA | Psoriasis | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Weeks 1–12 | Weeks 13–24 (ETN 25 mg) | |||||||||
| ETN + MTX | MTX | ETN | Placebo | ETN 25 mg | ETN 50 mg | Placebo | ETN 25 mg | ETN 50 mg | Placebo | |
| PCS | ||||||||||
| Baseline | 29.3 | 29.5 | 33.6 | 33.4 | 49.5 | 48.8 | 49.0 | – | – | – |
| Endpoint | 43.0 | 40.2 | 43.4 | 34.7 | 52.8 | 52.7 | 49.6 | 52.9 | 52.5 | 52.0 |
| Mean change | 13.8 | 10.9 | 9.7 | 1.5 | 3.3 | 3.9 | 0.7 | 3.4 | 3.7 | 3.1 |
| p Value | 0.003 | NS | 0.001 | NS | <0.0001 | <0.0001 | NS | |||
| MCS | ||||||||||
| Baseline | 42.1 | 42.2 | 51.5 | 49.3 | 48.4 | 47.2 | 46.1 | – | – | – |
| Endpoint | 48.9 | 48.3 | 54.1 | 50.3 | 51.0 | 50.6 | 46.5 | 51.1 | 51.4 | 49.1 |
| Mean change | 6.9 | 5.8 | 2.6 | 0.8 | 2.6 | 3.4 | 0.3 | 2.7 | 4.2 | 3.0 |
| p Value | NS | NS | 0.040 | NS | <0.0001 | <0.0001 | NS | |||
| SF-6D | ||||||||||
| Baseline | 0.530 | 0.528 | 0.660 | 0.642 | 0.754 | 0.734 | 0.728 | – | – | – |
| Endpoint | 0.658 | 0.635 | 0.767 | 0.659 | 0.819 | 0.822 | 0.739 | 0.822 | 0.821 | 0.808 |
| Mean change | 0.128 | 0.121 | 0.105 | 0.018 | 0.065 | 0.084 | 0.011 | 0.066 | 0.083 | 0.077 |
| p Value | <0.0001 | <0.0001 | <0.0001 | 0.079 | <0.0001 | <0.0001 | 0.285 | |||
All patients received etanercept 25 mg twice a week during weeks 13–24, column headers represent original treatment assignment, p values are comparisons with week 12 values.
Changes were greater than or equal to the minimal clinically important difference (MCID).
p Value for change from baseline.
ETN, etanercept; MCS, mental component summary; MTX, methotrexate; NS, not significant; PCS, physical component summary; PsA, psoriatic arthritis; RA, rheumatoid arthritis; SF-36, short form 36; SF-6D, health utility score based on mean scores across all eight domains of the SF-36.
Figure 1Short form 36 (SF-36) spydergrams for patients with rheumatoid arthritis. Mean SF-36 scores at baseline and week 52 and age and gender-matched norms are shown for patients receiving (A) methotrexate or (B) etanercept plus methotrexate. (C) Mean SF-36 scores at baseline and week 52 for patients treated with methotrexate or etanercept plus methotrexate are compared. Mean SF-36 scores for age and gender-matched norms are also shown. BP, bodily pain; ETN, etanercept; GH, general health; MH, mental health; MTX, methotrexate; PF, physical function; RE, role emotional; RP, role physical; SF, social functioning; VT, vitality.
Figure 2Short form 36 (SF-36) spydergrams for patients with psoriatic arthritis. Mean SF-36 scores at baseline and weeks 4, 12 and 24, and age and gender-matched norms are shown for patients receiving (A) placebo or (B) etanercept. (C) Mean SF-36 scores at baseline and week 24 for patients treated with placebo or etanercept are compared. Mean SF-36 scores for age and gender-matched norms are also shown. BP, bodily pain; ETN, etanercept; GH, general health; MH, mental health; PF, physical function; PL, placebo; RE, role emotional; RP, role physical; SF, social functioning; VT, vitality.
Figure 3Short form 36 (SF-36) spydergrams for patients with psoriasis. Mean SF-36 scores at baseline and week 12 of the randomised controlled trial (RCT) portion of the clinical trial and age and gender-matched norms are shown for patients receiving (A) placebo, (B) etanercept 25 mg twice a week (BIW), or (C) etanercept 50 mg twice a week. Mean SF-36 scores at baseline and weeks 12 and 24 of the open-label (OL) portion of the trial (when all patients received etanercept 25 mg twice a week) are shown for patients who had received (D) placebo, (E) etanercept 25 mg twice a week, or (F) etanercept 50 mg twice a week during the RCT portion of the trial. Mean SF-36 scores for age and gender-matched norms are also shown.
Figure 4Comparison of health-related quality of life (HRQoL) across indications. (A) Mean short form 36 (SF-36) scores for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or psoriasis (PsO) at baseline and average age and gender-matched norms for all indications are shown. (B) Mean SF-36 values at endpoint are shown for patients with RA (etanercept (ETN) plus methotrexate (MTX)-treated patients at week 52), PsA (etanercept-treated patients at week 24), and psoriasis (etanercept 50 mg twice a week (BIW)-treated patients at week 12) with average age and gender-matched norms for all indications. (C) Mean SF-36 scores at baseline for age and gender-matched norms are shown.