Table 2.
Cohen d effect sizes for selected outcomes in TNFi-naive and TNF-IR patients vs placebo in the FUTURE 2–5 trials
| Measure, Cohen d of mean change from baseline | Secukinumab 300 mg (n = 461) | Secukinumab 150 mg (n = 907) | Placebo (n = 681) | |||
|---|---|---|---|---|---|---|
| TNFi status | Naive (n = 316) | TNF-IR (n = 145) | Naive (n = 643) | TNF-IR (n = 264) | Naive (n = 477) | TNF-IR (n = 204) |
| Musculoskeletal domain | ||||||
| SJC66 | − 0.83 | − 0.67 | − 0.78 | − 0.48 | − 0.49 | − 0.13 |
| TJC68 | − 0.84 | − 0.60 | − 0.70 | − 0.48 | − 0.33 | − 0.10 |
| LDI | − 0.30 | − 0.19 | − 0.23 | − 0.15 | − 0.11 | − 0.08 |
| LEI | − 0.59 | − 0.44 | − 0.44 | − 0.39 | − 0.30 | − 0.01 |
| Skin | ||||||
| PASI score | − 1.11 | − 1.16 | − 0.90 | − 0.95 | − 0.31 | − 0.01 |
| IGA mod 2011 score | − 1.73 | − 1.75 | − 1.39 | − 1.05 | − 0.45 | − 0.39 |
| mNAPSI | − 0.68 | − 0.63 | − 0.63 | − 0.52 | − 0.19 | − 0.10 |
| Pain and physical function | ||||||
| PsA pain | − 0.83 | − 0.56 | − 0.73 | − 0.53 | − 0.29 | − 0.10 |
| HRQOL | ||||||
| HAQ-DI | − 0.97 | − 0.75 | − 0.81 | − 0.64 | − 0.48 | − 0.19 |
| SF-36 PCS | 0.94 | 0.76 | 0.78 | 0.58 | 0.37 | 0.23 |
| SF-36 MCS | 0.42 | 0.32 | 0.44 | 0.30 | 0.16 | 0.11 |
| PsAQOL | − 0.75 | − 0.54 | − 0.68 | − 0.49 | − 0.27 | − 0.12 |
| DLQI | − 0.92 | − 0.95 | − 1.01 | − 1.00 | − 0.32 | − 0.35 |
| Systemic inflammation | ||||||
| CRP | − 0.38 | − 0.41 | − 0.30 | − 0.33 | − 0.05 | − 0.02 |
| ESR | − 0.69 | − 0.49 | − 0.52 | − 0.44 | − 0.24 | 0.03 |
| Fatigue | ||||||
| FACIT-Fatigue | 0.66 | 0.64 | 0.63 | 0.47 | 0.25 | 0.12 |
| Patient global | ||||||
| Patient global assessment | − 0.77 | − 0.68 | − 0.61 | − 0.63 | − 0.33 | − 0.17 |
| Participation | ||||||
| WPAI:GH | − 0.58 | − 0.49 | − 0.48 | − 0.40 | − 0.25 | < 0.01 |
Effect size interpretation is subjective; generally, a magnitude in either the positive or negative direction was considered as 0.2 for small, 0.5 for moderate, 0.8 for large [33]
CRP C-reactive protein, DLQI Dermatology Life Quality Index, ESR erythrocyte sedimentation rate, FACIT-Fatigue Functional Assessment of Chronic Illness Therapy–Fatigue, HAQ-DI Health Assessment Questionnaire Disability Index, HRQOL health-related quality of life, IGA mod 2011 Investigator’s Global Assessment modified 2011, LDI Leeds Dactylitis Index, LEI Leeds Enthesitis Index, MCS mental component summary, mNAPSI modified Nail Psoriasis Severity Index, PASI Psoriasis Area and Severity Index, PCS physical component summary, PsA psoriatic arthritis, PsAQOL Psoriatic Arthritis Quality of Life, SF-36 36-item Short Form Health Survey, SJC swollen joint count, TJC tender joint count, TNFi tumor necrosis factor inhibitor, TNF-IR tumor necrosis factor inhibitor inadequate responder, VAS visual analog scale, WPAI:GH Work Productivity and Activity Impairment Questionnaire: General Health