Table 1

Change from baseline at weeks 24 and 52 in PROs by treatment groups (full analysis set)

PROsSecukinumab i.v.→150 mg
(n=202)
Secukinumab i.v.→75 mg
(n=202)
Placebo
(n=202)
Baseline mean (SD)LSM change from baseline at week 24 (SE)†Mean change from baseline at week 52
(SD)
Baseline mean (SD)LSM change from baseline at week 24
(SE)†
Mean change from baseline at week 52
(SD)
Baseline mean (SD)LSM change from baseline at week 24
(SE)†
PtGA55.2 (24.0)−20.6 (1.7)*−26.1 (25.8)56.1 (22.6)−20.0 (1.7)*−23.3 (27.7)55.6 (21.7)−7.4 (2.5)
PsA pain (VAS)55.7 (24.2)−20.8 (1.6)*−26.1 (25.4)55.1 (22.1)−20.4 (1.6)*−23.1 (26.0)56.7 (21.1)−6.7 (2.4)
HAQ-DI191.2 (0.68)−0.40 (0.04)*−0.46 (0.51)1.3 (0.67)−0.41 (0.04)*−0.45 (0.61)1.2 (0.64)−0.17 (0.05)
SF-36 PCS1936.2 (8.1)5.9 (0.5)*6.79 (7.5)36.9 (8.1)5.4 (0.5)*5. 56 (7.4)36.6 (8.0)1.8 (0.7)
SF-36 MCS42.8 (11.1)5.7 (0.6)**6.2 (9.6)42.0 (11.2)3.7 (0.6)4.8 (9.2)43.5 (11.3)2.4 (0.9)
SF-36 domains
 Physical functioning42.7 (25.4)13.0 (1.6)**15.0 (23.5)45.2 (24.5)12.7 (1.6)**13.1 (21.4)46.3 (24.9)5.6 (1.6)
 Role physical44.9 (24.3)17.3 (1.6)*19.5 (24.8)47.0 (24.8)12.4 (1.6)14.1 (21.6)46.4 (25.1)8.1 (1.6)
 Bodily pain35.7 (18.3)18.3 (1.5)**22.0 (21.9)36.4 (19.4)17.6 (1.5)**19.0 (21.1)36.7 (18.7)11.2 (1.5)
 General health42.2 (20.8)11.3 (1.2)*12.0 (19.1)40.9 (19.5)7.5 (1.2)9.4 (19.7)41.8 (20.0)4.6 (1.2)
 Vitality40.9 (21.5)13.1 (1.4)***14.6 (21.3)39.1 (21.1)10.9 (1.4)13.0 (19.9)41.1 (22.0)8.7 (1.4)
 Social functioning55.5 (27.3)16.0 (1.6)**20.2 (28.3)56.3 (26.7)12.6 (1.6)12.8 (20.9)58.0 (25.9)10.0 (1.6)
 Role emotional56.0 (27.5)13.5 (1.7)**15.4 (25.4)58.1 (27.4)9.3 (1.7)12.5 (23.5)58.0 (27.8)5.6 (1.7)
 Mental health59.0 (21.5)10.05 (1.2)***10.7 (18.3)56.2 (21.4)6.8 (1.2)8.9 (18.3)60.7 (21.4)5.9 (1.2)
PsAQoL10.3 (5.9)−3.5 (0.4)*−4.0 (5.7)10.7 (5.9)−3.2 (0.4)*−3.3 (5.3)10.7 (5.9)−0.4 (0.5)
FACIT-F28.9 (11.1)6.7 (0.7)***8.0 (9.7)27.6 (11.2)6.0 (0.7)6.7 (9.3)27.8 (11.1)4.0 (0.9)
WPAI-GH‡
 % Activity impairment due to healthn=195n=175n=174n=192n=170n=164n=199n=168
50.9 (26.4)−17.0 (26.7)−14.9 (30.2)49.4 (25.0)−12.3 (27.1)−12.9 (24.7)51.3 (26.4)−12.0 (25.5)
 % Work time missed due to healthn=94n=77n=77n=88n=67n=58n=108n=80
15.0 (28.4)−6.2 (25.6)−4.0 (27.7)6.6 (13.1)−1.5 (20.6)−3.0 (20.5)15.2 (26.6)0.7 (31.2)
 % Impairment while working due to healthn=88n=75n=73n=90n=68n=65n=107n=77
40.1 (26.7)−15.3 (26.7)−13.4 (26.9)37.6 (25.2)−14.7 (24.8)−18.3 (20.7)41.0 (26.1)−6.2 (22.7)
 % Overall work impairment due to healthn=89n=74n=71n=88n=67n=58n=105n=77
47.0 (29.8)−18.3 (29.3)−15.8 (28.8)40.2 (25.8)−15.4 (28.5)−18.8 (25.5)47.3 (28.9)−3.9 (26.3)
DLQI§¶12.6 (7.8)−8.8 (0.6)*−9.5 (7.5)11.2 (7.4)−7.9 (0.6)*−6.5 (8.5)12.5 (7.1)0.7 (0.8)
  • *p<0.0001, **p<0.01, ***p<0.05 versus placebo (p values of SF-36 PCS at week 24 adjusted for multiplicity).

  • LSM change data were from mixed-effect repeated measures model at week 24; mean (SD) data at week 52 are from observed data. Data collected after the subject was rescued were treated as missing for placebo subjects who switched to secukinumab, and the actual values were used for secukinumab subjects.

  • †Values are presented as mean (SD) for WPAI-GH.

  • ‡Percentages (%) of subjects employed at baseline were 51%, 48% and 61% for secukinumab i.v.→150 mg, secukinumab i.v.→75 mg and placebo, respectively.

  • §n=108 in the secukinumab i.v.→150 mg s.c. and secukinumab i.v.→75 mg s.c. groups; n=109 in the placebo group.

  • ¶Assessed only if ≥3% of body surface area was affected by psoriatic skin involvement at baseline.

  • DLQI, Dermatology Life Quality Index; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire Disability Index; LSM, least squares mean; MCS, mental component summary; PCS, physical component summary; PRO, patient-reported outcome; PsA, psoriatic arthritis; PsAQoL, psoriatic arthritis quality of life; PtGA, patient's global assessment of disease activity; s.c., subcutaneous; SF-36, Short Form-36 Health Survey; VAS, visual analogue scale; WPAI-GH, Work Productivity and Activity Impairment-General Health.