Long-term efficacy outcomes to week 96 of the RAPID-PsA trial for patients originally randomised to CZP
| Mean value (SD) or n (%) of patients | Week 0 CZP 200 mg Q2W (n=138) | Week 0 CZP 400 mg Q4W (n=135) | Week 0 CZP dose combined (n=273) |
|---|---|---|---|
| Baseline | |||
| MDA, n (%) | 0 | 1 (0.7) | 1 (0.4) |
| DAS28(CRP), mean (SD) | 5.0 (1.0) | 5.0 (1.0) | 5.0 (1.0) |
| DAS28(CRP) <2.6, n (%) | 0 | 1 (0.7) | 1 (0.4) |
| DAS28(CRP) ≤3.2, n (%) | 4 (2.9) | 3 (2.2) | 7 (2.6) |
| LEI, mean (SD)* | 3.1 (1.7) | 2.9 (1.6) | 3.0 (1.6) |
| LDI, mean (SD)† | 45.3 (36.0) | 56.8 (75.9) | 51.3 (60.0) |
| mNAPSI, mean (SD)‡ | 3.1 (1.8) | 3.4 (2.2) | 3.3 (2.0) |
| Week 48 | |||
| ACR20, n (%) (NRI) | 92 (66.7) | 89 (65.9) | 181 (66.3) |
| TNF-naïve§ | 74 (69.2) | 74 (66.1) | 148 (67.6) |
| TNF-experienced¶ | 18 (58.1) | 15 (65.2) | 33 (61.1) |
| ACR50, n (%) (NRI) | 68 (49.3) | 62 (45.9) | 130 (47.6) |
| TNF-naïve§ | 54 (50.5) | 50 (44.6) | 104 (47.5) |
| TNF-experienced¶ | 14 (45.2) | 12 (52.2) | 26 (48.1) |
| ACR70, n (%) (NRI) | 48 (34.8) | 41 (30.4) | 89 (32.6) |
| TNF-naïve§ | 38 (35.5) | 33 (29.5) | 71 (32.4) |
| TNF-experienced¶ | 10 (32.3) | 8 (34.8) | 18 (33.3) |
| PASI75, n (%)** (NRI) | 60 (66.7) | 47 (61.8) | 107 (64.5) |
| PASI≥10†† | 29 (78.4) | 26 (76.5) | 55 (77.5) |
| PASI<10‡‡ | 31 (58.5) | 21 (50.0) | 52 (54.7) |
| PASI90, n (%)** (NRI) | 44 (48.9) | 32 (42.1) | 76 (45.8) |
| PASI≥10†† | 21 (56.8) | 17 (50.0) | 38 (53.5) |
| PASI<10‡‡ | 23 (43.4) | 15 (35.7) | 38 (40.0) |
| PASI100, n (%)** (NRI) | 36 (40.0) | 21 (27.6) | 57 (34.3) |
| PASI≥10†† | 17 (45.9) | 10 (29.4) | 27 (38.0) |
| PASI<10‡‡ | 19 (35.8) | 11 (26.2) | 30 (31.6) |
| MDA, n (%) (NRI) | 55 (39.9) | 57 (37.8) | 106 (38.8) |
| DAS28(CRP), mean (SD) (LOCF) | 2.9 (1.3) | 3.1 (1.4) | 3.0 (1.3) |
| ΔBL DAS28(CRP), mean (SD) (LOCF) | −2.2 (1.3) | −2.0 (1.3) | −2.1 (1.3) |
| DAS28(CRP) <2.6, n (%) (LOCF) | 66 (47.8) | 54 (40.0) | 120 (44.0) |
| DAS28(CRP) ≤3.2, n (%) (LOCF) | 83 (60.1) | 79 (58.5) | 162 (59.3) |
| LEI, mean (SD)* (LOCF) | 1.0 (1.7) | 0.9 (1.6) | 0.9 (1.7) |
| ΔBL LEI, mean (SD)* (LOCF) | −2.1 (1.8) | −2.0 (1.8) | −2.0 (1.8) |
| LDI, mean (SD)† (LOCF) | 5.6 (17.0) | 2.9 (11.3) | 4.2 (14.3) |
| ΔBL LDI, mean (SD)† (LOCF) | −39.7 (33.1) | −53.9 (69.1) | −47.1 (55.0) |
| mNAPSI, mean (SD)‡ | 1.2 (1.8) | 1.1 (1.7) | 1.1 (1.7) |
| ΔBL mNAPSI, mean (SD)‡ (LOCF) | −1.9 (2.3) | −2.4 (2.3) | −2.1 (2.3) |
| Week 96 | |||
| ACR20, n (%) (NRI) | 95 (68.8) | 80 (59.3) | 175 (64.1) |
| TNF-naïve§ | 73 (68.2) | 68 (60.7) | 141 (64.4) |
| TNF-experienced¶ | 22 (71.0) | 12 (52.2) | 34 (63.0) |
| ACR50, n (%) (NRI) | 70 (50.7) | 66 (48.9) | 136 (49.8) |
| TNF-naïve§ | 54 (50.5) | 55 (49.1) | 109 (49.8) |
| TNF-experienced¶ | 16 (51.6) | 11 (47.8) | 27 (50.0) |
| ACR70, n (%) (NRI) | 47 (34.1) | 48 (35.6) | 95 (34.8) |
| TNF-naïve§ | 35 (32.7) | 42 (37.5) | 77 (35.2) |
| TNF-experienced¶ | 12 (38.7) | 6 (26.1) | 18 (33.3) |
| PASI75, n (%)** (NRI) | 53 (58.9) | 35 (46.1) | 88 (53.0) |
| PASI≥10†† | 24 (64.9) | 20 (58.8) | 44 (62.0) |
| PASI<10‡‡ | 29 (54.7) | 15 (35.7) | 44 (46.3) |
| PASI90, n (%)** (NRI) | 44 (48.9) | 29 (38.2) | 73 (44.0) |
| PASI≥10†† | 17 (45.9) | 16 (47.1) | 33 (46.5) |
| PASI<10‡‡ | 27 (50.9) | 13 (31.0) | 40 (42.1) |
| PASI100, n (%)** (NRI) | 33 (36.7) | 22 (28.9) | 55 (33.1) |
| PASI≥10†† | 9 (24.3) | 10 (29.4) | 19 (26.8) |
| PASI<10‡‡ | 24 (45.3) | 12 (28.6) | 36 (37.9) |
| MDA, n (%) (NRI) | 55 (39.9) | 57 (42.2) | 112 (41.0) |
| DAS28(CRP), mean (SD) (LOCF) | 2.8 (1.3) | 2.9 (1.4) | 2.8 (1.4) |
| ΔBL DAS28(CRP), mean (SD) (LOCF) | −2.2 (1.4) | −2.1 (1.3) | −2.2 (1.4) |
| DAS28(CRP) <2.6, n (%) (LOCF) | 66 (47.8) | 69 (51.1) | 135 (49.5) |
| DAS28(CRP) ≤3.2, n (%) (LOCF) | 82 (59.4) | 79 (58.5) | 161 (59.0) |
| LEI, mean (SD)* (LOCF) | 1.1 (1.8) | 0.8 (1.5) | 1.0 (1.7) |
| ΔBL LEI, mean (SD)* (LOCF) | −1.9 (1.8) | −2.1 (1.9) | −2.0 (1.9) |
| LDI, mean (SD)† (LOCF) | 2.4 (11.1) | 2.9 (11.3) | 2.7 (11.1) |
| ΔBL LDI, mean (SD)† (LOCF) | −42.9 (35.5) | −53.9 (69.1) | −48.6 (55.5) |
| mNAPSI, mean (SD)‡ (LOCF) | 0.9 (1.6) | 0.9 (1.4) | 0.9 (1.5) |
| ΔBL mNAPSI, mean (SD)‡ (LOCF) | −2.2 (2.3) | −2.6 (2.3) | −2.4 (2.3) |
Data shown are for the Randomised Set. Non-responder imputation was used for dichotomous outcomes and the last observation carried forward was used for continuous outcomes.
*The numbers of patients with enthesitis at baseline in CZP 200 mg Q2W, CZP 400 mg Q4W and CZP doses combined groups were 88, 84 and 172, respectively.
†The numbers of patients with dactylitis at baseline in CZP 200 mg Q2W, CZP 400 mg Q4W and CZP doses combined groups were 35, 38 and 73, respectively.
‡The numbers of patients with nail disease at baseline in CZP 200 mg Q2W, CZP 400 mg Q4W and CZP doses combined groups were 92, 105 and 197, respectively.
§The numbers of patients without prior anti-TNF exposure in CZP 200 mg Q2W, CZP 400 mg Q4W and CZP doses combined groups were 107, 112 and 219, respectively.
¶The numbers of patients with prior anti-TNF exposure in CZP 200 mg Q2W, CZP 400 mg Q4W and CZP doses combined groups were 31, 23 and 54, respectively.
**The numbers of patients with baseline psoriasis BSA≥3% in CZP 200 mg Q2W, CZP 400 mg Q4W and CZP doses combined groups were 90, 76 and 166, respectively.
††The numbers of patients with psoriasis BSA≥3% and PASI score ≥10 at baseline in CZP 200 mg Q2W, CZP 400 mg Q4W and CZP doses combined groups were 37, 34 and 71, respectively.
‡‡The numbers of patients with psoriasis BSA≥3% and PASI score <10 at baseline in CZP 200 mg Q2W, CZP 400 mg Q4W and CZP doses combined groups were 53, 42 and 95, respectively.
ACR, American College of Rheumatology; BL, baseline; BSA, body surface area; CRP, C reactive protein; CZP, certolizumab pegol; DAS, Disease Activity Score; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; LOCF, carrying forward the last observation; MDA, minimal disease activity; NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index; Q2W, every 2 weeks; TNF, tumour necrosis factor.