Table 2.
Efficacy overview at week 156 (ixekizumab intention-to-treat population)
| Ixekizumab Q4W (n = 107) |
Ixekizumab Q2W (n = 103) |
|||||
|---|---|---|---|---|---|---|
| Responder rate,n/Nx (%) | mNRI | NRI | MI | mNRI | NRI | MI |
| ACR20 | 75/107 (69.8) | 54/107 (50.5) | 95/107 (89.3) | 64/103 (62.5) | 52/103 (50.5) | 91/103 (88.1) |
| ACR50 | 55/107 (51.8) | 41/107 (38.3) | 68/107 (63.7) | 58/103 (56.1) | 47/103 (45.6) | 79/103 (76.7) |
| ACR70 | 36/107 (33.4) | 29/107 (27.1) | 41/107 (38.2) | 45/102 (43.8) | 37/103 (35.9) | 57/102 (55.6) |
| MDA | 43/106 (40.6) | 36/107 (33.6) | 52/106 (49.4) | 50/103 (48.9) | 44/103 (42.7) | 70/103 (68.0) |
| VLDA | 19/107 (17.3) | 18/107 (16.8) | 19/107 (17.9) | 22/103 (21.0) | 21/103 (20.4) | 25/103 (23.8) |
| LDAa | 68/107 (63.6) | 51/107 (50.5) | 85/107 (79.9) | 64/103 (62.5) | 54/103 (54.7) | 90/103 (87.2) |
| Remissionb | 27/107 (24.8) | 24/107 (22.4) | 29/107 (27.3) | 31/103 (29.9) | 29/103 (28.2) | 38/103 (36.6) |
| PASDAS LDA ≤3.2 | 49/104 (46.9) | 39/107 (36.4) | 63/103 (61.4) | 59/102 (57.6) | 51/103 (49.5) | 83/102 (80.9) |
| PASDAS ≤1.9 | 22/104 (21.4) | 20/107 (18.7) | 25/103 (24.7) | 28/102 (27.8) | 26/103 (25.2) | 36/102 (35.3) |
| LEI=0c | 32/68 (47.4) | 26/68 (38.2) | 45/68 (65.9) | 23/57 (40.3) | 19/57 (33.3) | 33/57 (57.5) |
| LDI-B=0d | 23/37 (61.6) | 21/39 (53.8) | 26/37 (70.1) | 17/25 (69.3) | 17/26 (65.4) | 21/25 (84.9) |
| PASI 75e | 46/73 (63.5) | 35/73 (47.9) | 61/73 (84.1) | 41/59 (69.1) | 36/59 (61.0) | 58/59 (97.5) |
| PASI 90e | 37/73 (51.2) | 28/73 (38.4) | 50/73 (68.7) | 38/59 (64.5) | 34/59 (57.6) | 54/59 (91.7) |
| PASI 100e | 32/73 (43.6) | 24/73 (32.9) | 43/73 (58.6) | 36/59 (60.5) | 32/59 (54.2) | 49/59 (83.7) |
| NAPSI (0)f | 36/68 (53.6) | 28/69 (40.6) | 52/68 (76.0) | 42/74 (57.1) | 38/74 (51.4) | 60/74 (81.1) |
| HAQ-DI MCIDg | 51/100 (51.1) | 39/100 (39.0) | 64/100 (63.7) | 46/90 (50.8) | 39/90 (43.3) | 67/90 (74.8) |
|
| ||||||
| Change from baseline h | mBOCF | MI | mBOCF | MI | ||
|
| ||||||
| LEIc | −1.7 (1.8) | −2.1 (0.2) | −1.7 (1.7) | −2.5 (0.2) | ||
| LDI-Bd | −51.2 (91.0) | −60.7 (15.6) | −55.4 (61.3) | −59.9 (11.9) | ||
| NAPSIf | −15.2 (19.9) | −17.6 (2.7) | −16.7 (21.9) | −23.6 (2.5) | ||
| HAQ-DI | −0.37 (0.57) | −0.49 (0.06) | −0.49 (0.59) | −0.66 (0.07) | ||
| SF-36 PCS score | 7.9 (10.2) | 10.3 (1.1) | 8.3 (9.6) | 10.9 (1.0) | ||
| SF-36 MCS score | 3.5 (11.6) | 4.1 (1.3) | 3.8 (10.3) | 5.2 (1.1) | ||
| EQ-5D VAS | 12.0 (24.8) | 14.7 (2.9) | 13.7 (21.1) | 18.3 (2.5) | ||
| WPAI absenteeism | −4.8 (18.8) | −8.7 (2.9) | 0.2 (27.7) | −2.5 (4.1) | ||
| WPAI activity impairment | −21.3 (26.1) | −28.3 (2.8) | −26.1 (26.0) | −32.1 (2.7) | ||
| WPAI presenteeism | −18.0 (27.2) | −28.4 (4.2) | −21.2 (21.8) | −25.0 (3.3) | ||
| WPAI work productivity | −17.5 (26.0) | −29.4 (4.1) | −18.2 (25.0) | −24.8 (3.5) | ||
DAPSA score >4 and ≤14.
DAPSA score ≤4.
Patients with baseline LEI > 0.
Patients with baseline LDI-B > 0.
Patients with baseline psoriasis of ≥3% body surface area.
Patients with baseline fingernail psoriasis present.
Patients with baseline HAQ-DI score ≥0.35.
Data are presented as the mean (s.e.m.) for MI analysis and mean (s.d.) for mBOCF analysis.
DAPSA: disease activity index for psoriatic arthritis; EQ-5D: EuroQoL 5 dimension questionnaire; LDA: low disease activity; LDI-B: Leeds dactylitis index-basic; LEI: Leeds enthesitis index; mBOCF: modified baseline observation carried forward; MCID: minimal clinically important difference; MCS: mental component summary; MDA: minimal disease activity; MI: multiple imputation; mNRI: modified non-responder imputation; NAPSI: nail psoriasis severity index; NR: near remission; Nx: number of patients with non-missing data; PASDAS: psoriatic arthritis disease activity score; PASI: psoriasis area and severity index; PCS: physical component summary; Q4W/Q2W: 80 mg once every 4 weeks/2 weeks; SF-36: 36-item short form health survey; VAS: visual analog scale; VLDA: very low disease activity; WPAI: work productivity and activity impairment questionnaire.