| Literature DB >> 24942382 |
A Kavanaugh1, D Gladman2, D van der Heijde3, O Purcaru4, P Mease5.
Abstract
OBJECTIVES: To evaluate the effect of certolizumab pegol (CZP) on productivity outside and within the home, and on participation in family, social and leisure activities in adult patients with psoriatic arthritis (PsA).Entities:
Mesh:
Substances:
Year: 2014 PMID: 24942382 PMCID: PMC4283690 DOI: 10.1136/annrheumdis-2014-205198
Source DB: PubMed Journal: Ann Rheum Dis ISSN: 0003-4967 Impact factor: 19.103
RAPID-PsA baseline demographics and disease characteristics at study baseline (RS population, observed cases)
| Placebo | CZP | CZP | All patients | |
|---|---|---|---|---|
| Demographic characteristics* | ||||
| Age, years | 47.3±11.1 | 48.2±12.3 | 47.1±10.8 | 47.6±11.4 |
| Sex, % female | 58.1 | 53.6 | 54.1 | 55.3 |
| Weight, kg | 82.6±19.9† | 85.8±17.7 | 84.8±18.7 | 84.4±18.8‡ |
| BMI, kg/m2 | 29.2±6.7† | 30.5±6.2 | 29.6±6.6 | 29.8±6.5‡ |
| Arthritis characteristics | ||||
| Tender joint count (0–68 joints) | 19.9±14.7 | 21.5±15.3 | 19.6±14.8 | 20.3±14.9 |
| Swollen joint count (0–66 joints) | 10.4±7.6 | 11.0±8.8 | 10.5±7.5 | 10.7±8.0 |
| Physician's assessment of disease activity, by VAS, mm | 58.7±18.7 | 56.8±18.2 | 58.2±18.9 | 57.9±18.6 |
| Psoriasis characteristics | ||||
| Psoriasis BSA ≥3%, n (%) | 86 (63.2) | 90 (65.2) | 76 (56.3) | 252 (61.6) |
| PASI, median (min–max)§ | 7.1 (0.3–55.2) | 6.8 (0.6–72.0) | 8.1 (0.6–51.8) | 7.2 (0.3–72.0) |
| Concomitant medication¶ | ||||
| MTX use, % | 61.8 | 63.8 | 65.2 | 63.6 |
| CS use, % | 28.7 | 36.2 | 25.9 | 30.0 |
There were no significant differences between treatment groups at baseline.
*Except where indicated otherwise, values are the mean±SD.
†n=135.
‡n=408.
§PASI scores for those patients with psoriasis body surface area ≥3% at baseline.
¶Refers to concomitant use of MTX or any CS taken for at least 1 day during the 24-week double-blind treatment period.
BMI, body mass index; BSA, body surface area; CS, corticosteroid; CZP, certolizumab pegol; MTX, methotrexate; PASI, Psoriasis Area and Severity Index; Q2W, every 2 weeks; Q4W, every 4 weeks; RS, randomised set; VAS, visual analogue scale.
Figure 1RAPID-PsA: employment status at study baseline (randomised set population, observed cases). Other non-employed includes: student, unable to work due to non-arthritis and other non-employed status. CZP, certolizumab pegol; PBO, placebo; Q2W, every 2 weeks; Q4W, every 4 weeks.
RAPID-PsA: burden of PsA on productivity in the workplace and within the home at study baseline (RS population, observed cases)
| Placebo | CZP 200 mg Q2W | CZP 400 mg Q4W | All patients | |||||
|---|---|---|---|---|---|---|---|---|
| Mean | Median | Mean | Median | Mean | Median | Mean | Median | |
| Work days missed due to arthritis | 2.6 | 0.0 | 2.0 | 0.0 | 1.6 | 0.0 | 2.0 | 0.0 |
| Days with work productivity reduced by ≥50% due to arthritis* | 3.8 | 0.0 | 5.2 | 0.0 | 5.1 | 0.0 | 4.7 | 0.0 |
| Rate of arthritis interference with work productivity† | 4.2 | 5.0 | 4.4 | 5.0 | 3.8 | 4.0 | 4.1 | 5.0 |
| Days with no household work due to arthritis | 5.6 | 1.5 | 5.9 | 0.0 | 5.5 | 2.0 | 5.7 | 2.0 |
| Days with household work productivity reduced by ≥50% due to arthritis* | 8.6 | 5.0 | 7.1 | 4.0 | 7.1 | 5.0 | 7.6 | 5.0 |
| Days missed of family, social or leisure activities due to arthritis | 3.7 | 0.0 | 4.1 | 0.0 | 3.3 | 0.0 | 3.7 | 0.0 |
| Days with outside help hired due to arthritis | 2.2 | 0.0 | 2.5 | 0.0 | 2.7 | 0.0 | 2.4 | 0.0 |
| Rate of arthritis interference with household work productivity† | 4.9 | 5.0 | 5.2 | 5.0 | 4.9 | 5.0 | 5.0 | 5.0 |
*Does not include days counted in the previous question, ‘Work days missed due to arthritis’.
†0–10 scale, where 0=no interference, 10=complete interference.
CZP, certolizumab pegol; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; RS, randomised set.
Figure 2RAPID-PsA: monthly improvements in paid work productivity (employed patients, randomised set population). Left hand panels represent work productivity outcomes up to week 24, right hand panels represent frequency distribution plots at baseline (BL), week 4 and week 24. Non-parametric bootstrap-t test, last observation carried forward. *Certolizumab pegol (CZP) 200 mg Q2W vs placebo (PBO) p-value ≤0.05; ‡CZP 400 mg Q4W vs PBO p-value <0.05; †0–10 point scale (0=no interference, 10=complete interference).
RAPID-PsA: improvements in productivity in the workplace and within the home at week 24 (RS population, LOCF)
| Placebo | CZP 200 mg Q2W | CZP 400 mg Q4W | CZP 200 mg | CZP 400 mg | |
|---|---|---|---|---|---|
| Mean | |||||
| Work days missed due to arthritis | 1.6 | 0.2 | 0.6 | −1.4 (−3.4 to −0.6) | −1.0 (−2.8 to −0.1) |
| Days with work productivity reduced by ≥50% due to arthritis* | 3.5 | 1.3 | 2.1 | −2.2 (−4.1 to −0.7) | −1.4 (−3.4 to 0.6) |
| Rate of arthritis interference with work productivity† | 3.2 | 1.7 | 1.9 | −1.4 (−2.3 to −0.7) | −1.2 (−2.1 to −0.4) |
| Days with no household work due to arthritis | 4.7 | 2.5 | 2.4 | −2.3 (−4.0 to −0.7) | −2.2 (−3.9 to −0.6) |
| Days with household work productivity reduced by ≥50% due to arthritis* | 6.8 | 2.9 | 3.5 | −3.9 (−5.8 to −2.2) | −3.4 (−5.3 to −1.5) |
| Days missed of family, social or leisure activities due to arthritis | 2.8 | 1.1 | 1.0 | −1.7 (−3.1 to −0.5) | −1.8 (−3.2 to −0.6) |
| Days with outside help hired due to arthritis | 1.9 | 0.7 | 1.5 | −1.2 (−2.4 to −0.3) | −0.4 (−1.7 to 1.0) |
| Rate of arthritis interference with household work productivity† | 4.1 | 2.2 | 2.6 | −1.8 (−2.5 to −1.2) | −1.5 (−2.1 to −0.8) |
*Does not include days counted in the previous question, ‘Work days missed due to arthritis’.
†0–10 scale, where 0=no interference, 10=complete interference.
CZP, certolizumab pegol; LOCF, last observation carried forward; Q2W, every 2 weeks; Q4W, every 4 weeks; RS, randomised set.
Figure 3RAPID-PsA: monthly improvements in productivity within the household and in family, social and leisure activities (randomised set population). Left hand panels represent work productivity outcomes up to week 24, right hand panels represent frequency distribution plots at baseline (BL), week 4 and week 24. Non-parametric bootstrap-t test, last observation carried forward. *Certolizumab pegol (CZP) 200 mg Q2W vs placebo (PBO) p-value ≤0.05; ‡CZP 400 mg Q4W vs PBO p-value <0.05; †0–10 point scale (0=no interference, 10=complete interference).