Clinical disease activity and patient-reported outcomes in patients randomised to CZP treatment at Week 0
| Week 0 CZP dose combined (n=273) | |||||||||||
| Baseline value | Week 24 | Week 48 | Week 216 | ||||||||
| Observed | Observed | Imputed | Observed | Imputed | Observed | Imputed | |||||
| n | n | n | n | ||||||||
| Clinical outcomes: % patients achieving outcome, unless otherwise indicated | |||||||||||
| ACR20 | − | 249 | 65.9 | 60.1 | 235 | 77.0 | 66.3 | 185 | 80.5 | 54.6 | |
| Naive* | − | 199 | 66.3 | 60.3 | 190 | 77.9 | 67.6 | 151 | 80.1 | 55.3 | |
| Experienced† | − | 50 | 64.0 | 59.3 | 45 | 73.3 | 61.1 | 34 | 82.4 | 51.9 | |
| ACR50 | − | 249 | 47.4 | 43.2 | 235 | 55.7 | 48.0 | 185 | 63.8 | 43.2 | |
| Naive* | − | 199 | 47.2 | 42.9 | 190 | 55.3 | 47.9 | 151 | 63.6 | 43.8 | |
| Experienced† | − | 50 | 48.0 | 44.4 | 45 | 57.8 | 48.1 | 34 | 64.7 | 40.7 | |
| ACR70 | − | 249 | 28.9 | 26.4 | 235 | 38.7 | 33.3 | 185 | 51.4 | 34.8 | |
| Naive* | − | 199 | 29.1 | 26.5 | 190 | 38.4 | 33.3 | 151 | 52.3 | 36.1 | |
| Experienced† | − | 50 | 28.0 | 25.9 | 45 | 40.0 | 33.3 | 34 | 47.1 | 29.6 | |
| CFB DAPSA, mean (SD) | 273 | 44.8 (22.9) | 249 | −26.8 (20.2) | −25.9 (21.0) | 239 | −29.4 (20.7) | −27.8 (21.6) | 185 | −33.7 (21.5) | −29.5 (23.5) |
| DAPSA LDA | 273 | 1.5 | 249 | 29.7 | 28.2 | 239 | 37.7 | 34.8 | 185 | 31.9 | 30.4 |
| DAPSA remission | 273 | 0 | 249 | 25.3 | 23.4 | 239 | 28.5 | 25.6 | 185 | 44.3 | 35.9 |
| MDA | 273 | 0.4 | 249 | 38.2 | 34.8 | 237 | 45.1 | 39.2 | 185 | 57.8 | 39.2 |
| VLDA | 273 | 0 | 249 | 14.9 | 13.6 | 233 | 19.7 | 16.8 | 183 | 29.0 | 19.4 |
| PASI75‡ | − | 144 | 70.8 | 61.4 | 136 | 78.7 | 64.5 | 108 | 79.6 | 51.8 | |
| PASI90‡ | − | 144 | 47.9 | 41.6 | 136 | 55.9 | 45.8 | 108 | 62.0 | 40.4 | |
| PASI100‡ | − | 144 | 25.7 | 22.3 | 136 | 41.9 | 34.3 | 108 | 43.5 | 28.3 | |
| CFB % BSA ‡, mean (SD) | 166 | 24.2 (22.4) | 149 | −17.0 (18.9) | −16.1 (19.5) | 140 | −18.8 (20.4) | −17.5 (20.6) | 109 | −21.0 (19.6) | −18.3 (20.4) |
| BSA ≤1%‡ | − | 149 | 38.9 | 35.5 | 140 | 55.7 | 50.6 | 109 | 62.4 | 55.4 | |
| CFB tender joint count, mean (SD) | 273 | 20.5 (15.0) | 249 | −12.1 (12.8) | −11.6 (13.7) | 235 | −13.0 (13.4) | −12.4 (14.2) | 185 | −15.8 (13.1) | −13.5 (14.8) |
| CFB swollen joint count, mean (SD) | 273 | 10.8 (8.2) | 249 | −7.8 (7.6) | −7.7 (7.7) | 235 | −8.6 (7.4) | −8.5 (7.6) | 185 | −9.3 (8.2) | −8.8 (8.0) |
| CFB mNAPSI§, mean (SD) | 197 | 3.3 (2.0) | 179 | −2.0 (2.1) | −1.9 (2.2) | 172 | −2.3 (2.3) | −2.1 (2.3) | 132 | −2.9 (1.9) | −2.6 (2.2) |
| mNAPSI=0§ | − | 179 | 38.5 | 36.5 | 172 | 54.1 | 50.8 | 132 | 71.2 | 64.5 | |
| CFB LEI¶ , mean (SD) | 172 | 3.0 (1.6) | 158 | −1.9 (1.9) | −1.9 (1.8) | 149 | −2.1 (1.8) | −2.0 (1.8) | 110 | −2.4 (1.7) | −2.2 (1.9) |
| LEI=0¶ | − | 158 | 65.2 | 64.0 | 149 | 71.1 | 68.0 | 110 | 77.3 | 70.9 | |
| CFB LDI**, mean (SD) | 73 | 51.3 (60.0) | 65 | −46.3 (41.3) | −47.3 (55.3) | 62 | −46.8 (41.3) | −47.1 (55.0) | 50 | −50.3 (39.5) | −47.5 (55.4) |
| LDI=0** | − | 65 | 73.8 | 69.9 | 62 | 88.7 | 80.8 | 50 | 92.0 | 80.8 | |
| Patient-reported outcomes: mean (SD) | |||||||||||
| CFB HAQ-DI | 273 | 1.31 (0.63) | 248 | −0.50 (0.59) | −0.48 (0.60) | 236 | −0.57 (0.59) | −0.52 (0.61) | 185 | −0.57 (0.63) | −0.50 (0.65) |
| CFB pain | 273 | 60.4 (19.6) | 249 | −29.7 (27.2) | −28.5 (27.2) | 238 | −33.6 (27.4) | −30.6 (28.3) | 185 | −37.4 (27.2) | −32.1 (29.7) |
| CFB fatigue | 269 | 6.3 (2.1) | 239 | −2.2 (2.5) | −2.0 (2.5) | 233 | −2.3 (2.4) | −2.2 (2.5) | 181 | −2.7 (2.7) | −2.3 (2.7) |
| CFB PsAQoL | 272 | 11.2 (5.6) | 248 | −4.1 (5.2) | −3.9 (5.1) | 238 | −4.5 (5.2) | −4.2 (5.2) | 184 | −5.1 (5.5) | −4.5 (5.7) |
| CFB SF-36 PCS | 268 | 33.2 (7.7) | 240 | +8.5 (9.0) | +8.0 (9.1) | 232 | +9.3 (9.1) | +8.5 (9.2) | 181 | +9.9 (10.3) | +8.8 (10.2) |
| CFB SF-36 MCS | 268 | 41.3 (12.0) | 240 | +4.9 (9.6) | +4.5 (10.0) | 232 | +4.4 (10.1) | +4.0 (10.1) | 181 | +5.4 (10.6) | +3.6 (11.3) |
Data are shown for the Randomised Set. Data were imputed using NRI for missing categorical data, except for total resolution of enthesitis (LEI=0), dactylitis (LDI=0) and nail psoriasis (mNAPSI=0), missing values for which were imputed by LOCF; missing continuous data were imputed by LOCF.
*Anti-TNF naive patients, n=219.
†Anti-TNF experienced patients, n=54.
‡Patients with baseline BSA ≥3%, n=166.
§Patients with mNAPSI >0 at BL, n=197.
¶Patients with LEI >0 at BL, n=172.
**Patients with LDI >0 at BL, defined as having at least 1 digit affected and with a difference in circumference ≥10% compared with the opposite digit, n=73.
ACR, American College of Rheumatology; ACR20/50/70: 20% , 50% and 70% or greater improvement in ACR score; BL, baseline; BSA, body surface area; CFB, change from baseline; CZP, certolizumab pegol; DAPSA, Disease Activity Index for Psoriatic Arthritis; HAQ-DI, Health Assessment Questionnaire Disability Index; LDA, low disease activity; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; LOCF, last observation carried forward; MCS, mental component summary; MDA, minimal disease activity; mNAPSI, modified Nail Psoriasis Severity Index; NRI, non-responder imputation; PASI75/90/100, 75%, 90% or 100% improvement in the Psoriasis Area and Severity Index; PCS, physical component summary; PsAQoL, PsA quality of life; SF-36, Short Form 36-item health survey; TNF, tumour necrosis factor; VLDA, very low disease activity.