Article Figures & Data
Figures
- Figure 1.
Percentage of patients reporting improvements above the respective MCID of the patient-reported outcomes pain (on VAS), global disease activity (VAS), fatigue (FACIT-F), function (HAQ-DI), and HRQOL (SF-36 PCS). *Significant differences, p < 0.05. FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI: Health Assessment Questionnaire Disability Index; SF-36 PCS: 36-Item Medical Outcomes Study Short Form-36 Health Survey physical component summary; HRQOL: health-related quality of life; VAS: visual analog scale.
- Figure 2.
A. SF-36 domain scores at baseline and endpoint (Week 12) in patients receiving placebo versus age- and sex-matched norms. Gridlines represent changes of 10 points each, from minimum clinically important differences (MCID) to 2×MCID. An increase in score indicates improvement. Innermost polygon (dark blue): health-related quality of life (HRQOL) reported at baseline. Outer polygon (lavender): age- and sex-matched US normative values specific to this protocol population. Intermediate polygon (light blue): improvements in placebo at endpoint (Week 12). B. SF-36 domain scores at baseline and endpoint in patients receiving apremilast 20 mg BID versus age- and sex-matched norms. Gridlines represent changes of 10 points each (from MCID to 2×MCID). An increase in score indicates improvement. Innermost polygon (dark blue): HRQOL reported at baseline. Outer polygon (lavender): age- and sex-matched US normative values specific to this protocol population. Intermediate polygon (light blue): improvements in apremilast 20 mg BID at endpoint at Week 12, statistically significant in 7 of 8 domains and ≥ MCID in 6. C. SF-36 domain scores at baseline and endpoint in patients receiving apremilast 40 mg QD versus age- and sex-matched norms. Gridlines represent changes of 10 points each (from MCID to 2×MCID). An increase in score indicates improvement. Innermost polygon (dark blue): HRQOL reported at baseline. Outer polygon (lavender): age- and sex-matched US normative values specific to this protocol population. Intermediate polygon (light blue): improvements in apremilast 40 mg QD at endpoint at Week 12, statistically significant and ≥ MCID in the BP domain. *≥ MCID. SF-36: Medical Outcomes Study Short Form-36; BP: Bodily Pain; PF: Physical Function; MH: Mental Health; RE: Role-Emotional; RP: Role-Physical; SF: Social Function; VT: Vitality; GH: General Health.
Tables
- Table 1.
Overview of patient-reported health-related quality of life instruments27,28,29,30,31,32.
Instrument Description Assessment MCID Global disease activity and pain by VAS Disease activity and pain scales 0–100 mm, include “anchors” Improvement: 10.0 points HAQ-DI Functional ability questionnaire 0–3 (0 = no difficulty, 3 = unable to do) Improvement: −0.13 points* and −0.3 points* FACIT-F Fatigue questionnaire; 13 questions evaluated on 5-point scale 0–4 (0 = not at all, 4 = very much) Improvement: 4.0 SF-36 domains Self-administered instrument assessing 8 health domains: (1) PF: limitations in physical activities; (2) RP: limitations in usual role activities; (3) BP: bodily pain; (4) GH: general health perceptions; (5) VT: vitality; (6) RE: limitations in usual role activities; (7) SF: limitations in social activities; (8) MH: general mental health 0–100 points, worst to best Improvement: 5.0 points
Deterioration: −2.5 pointsSF-36 physical and mental component summary scores (PCS and MCS) Summarizes SF-36 subscale scores 0–50 points (normative value = 50, SD 10) Improvement: 2.5 points
Deterioration: −0.8 pointsSF-6D (utility-based measure) Preference-based measure derived from the SF-36; yields a single score that qualifies changes across all 8 SF-36 domains 0.296–1.0 (0 = death, 1.0 = perfect health) MID ≥ 0.041 -
↵* MCID for HAQ-DI was analyzed using 2 different definitions based on 2 published MCID levels in PsA: −0.1331 and −0.332. The present study population more closely resembles the population studied in Kwok, et al31 (MCID, −0.13); however, the more stringent level reported by Mease, et al32 (MCID, −0.3) was included for comparative purposes. FACIT-F: Functional Assessment of Chronic Illness Therapy for Fatigue; HAQ-DI: Health Assessment Questionnaire Disability Index; MCID: minimum clinically important differences; MCS: mental component summary; MID: minimum important differences; PCS: physical component summary; SF-36: 36-Item Medical Outcomes Study Short-Form Health Survey, version 2; SF-6D: 6-Domain Short-Form Health Survey; VAS: visual analog scale.
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Characteristic Placebo, n = 68 Apremilast 20 mg BID, n = 69 Apremilast 40 mg QD, n = 67 Age, mean yrs 51.1 50.9 49.9 Male, n (%) 32 (47.1) 43 (62.3) 32 (47.8) Race, n (%) White 68 (100.0) 67 (97.1) 62 (92.5) Black 0 0 1 (1.5) Hispanic 0 0 1 (1.5) Asian/Pacific Islander 0 1 (1.4) 2 (3.0) Other 0 1 (1.4) 1 (1.5) Smokers, n (%) 15 (22.1) 14 (20.3) 13 (19.4) Weight, mean (SD), lb 200.5 (39.2) 184.4 (33.7) 195.7 (44.2) Body mass index, mean (SD), kg/m2 31.5 (5.52) 28.2 (4.40) 31.0 (7.14) PsA disease category, n (%) Asymmetrical oligoarthritis 20 (29.4) 21 (30.4) 26 (38.8) Predominant spondylitis 2 (2.9) 3 (4.3) 4 (6.0) Symmetric polyarthritis 39 (57.4) 36 (52.2) 32 (47.8) Arthritis mutilans 5 (7.4) 0 2 (3.0) Predominant DIP involvement 2 (2.9) 9 (13.0) 2 (3.0) PsA history, mean yrs* 7.3 8.4 7.6 Joint counts Pain/tender score 21.3 20.6 23.2 Swelling score 9.5 10.6 8.4 Psoriasis severity, n (%) None 12 (17.6) 7 (10.1) 2 (3.0) Mild 40 (58.8) 47 (68.1) 41 (61.2) Moderate 11 (16.2) 15 (21.7) 20 (29.9) Severe 5 (7.4) 0 4 (6.0) Psoriasis history, mean yrs 15.8 15.5 18.3 Methotrexate use, n (%) 29 (42.6) 30 (43.5) 30 (44.8) CRP, mean (range), mg/l 14.9 (3.0–237.0) 10.4 (3.0–65.4) 10.9 (3.0–95.0) -
↵* January was used for a missing month and 01 was used for a missing day to calculate the years of history. CRP: C-reactive protein; DIP: distal interphalangeal joints; PsA: psoriatic arthritis.
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Measure, mean (SD) Placebo Apremilast 20 mg BID Apremilast 40 mg QD Global VAS (0–100) Baseline 58.3 (23.87) 54.3 (19.53) 55.7 (22.47) Week 12/final visit 59.4 (24.0) 45.3 (25.9) 45.0 (25.5) Change from baseline 1.0 (19.2) −10.3 (24.6)* −10.4 (23.6)* Pain VAS (0–100) Baseline 59.7 (22.64) 55.7 (18.82) 57.1 (23.77) Week 12/final visit 58.5 (24.4) 44.9 (25.9) 44.8 (26.1) Change from baseline −1.3 (19.7) −11.2 (22.8)* −11.5 (22.6)* HAQ-DI (0–3) Baseline 1.24 (0.77) 0.96 (0.65) 1.08 (0.71) Week 12/final visit 1.18 (0.78) 0.80 (0.63) 0.93 (0.71) Change from baseline −0.05 (0.39) −0.16 (0.35) −0.15 (0.39) FACIT-F (0–52) Baseline 28.8 (11.76) 32.1 (11.92) 27.7 (12.78) Week 12/final visit 29.5 (13.33) 36.2 (11.80) 32.0 (12.25) Change from baseline 0.5 (8.03) 4.1 (8.78)* 4.3 (9.46)* SF-36 MCS Baseline 43.6 45.0 43.5 Week 12/final visit 44.0 48.3 44.7 Change from baseline −0.8 3.4* 1.1 SF-36 PCS Baseline 33.3 37.3 34.8 Week 12/final visit 34.1 40.2 36.9 Change from baseline 0.8 2.4* 2.1 -
↵* p < 0.05 vs. placebo. FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI: Health Assessment Questionnaire Disability Index; MCS: mental component summary; PCS: physical component summary; VAS: visual analog scale; SF-36: 36-item Medical Outcomes Study Short-Form Health Survey.
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- Table 4.
Correlations between mean changes in SF-36 domains and pain VAS, HAQ-DI, and FACIT-F*.
Placebo Apremilast 20 mg BID Apremilast 40 mg QD SF-36 BP with pain VAS −0.47 −0.57 −0.54 p < 0.001 < 0.001 < 0.001 SF-36 PF with HAQ-DI −0.14 −0.46 −0.73 p NS < 0.001 < 0.001 SF-36 VT with FACIT-F 0.41 0.66 0.55 p < 0.001 < 0.001 NS -
↵* Correlations > 0.30 ≤ 0.60 are considered moderate; > 0.60 high. BP: Bodily Pain; FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI: Health Assessment Questionnaire Disability Index; NS: not significant; PF: Physical Function; SF-36: 36-Item Medical Outcomes Study Short-Form Health Survey; VAS: visual analog scale; VT: Vitality.
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