Table 2.
Recommendations for the selection of primary outcome of RCTs for psoriasis and psoriatic arthritis
| Items | Suggested Indicators | Not suggested Indicators | ||
|---|---|---|---|---|
| Psoriasis | Psoriatic arthritis | Psoriasis | Psoriatic arthritis | |
| Overall |
PASI 50 PASI 75 IGA 0,1 |
PASI 75 PASI 50 PASI 90 |
PASI 125 DLQI 0,1 NRS-4 |
ACR 70 MDA ACR 50 |
| Baseline severity of participants | ||||
| All |
PASI 50 IGA 0,1 |
PASI 75 PASI 90 ACR 20 |
PASI 90 PatGA 0,1 |
ACR 70 MDA ACR 50 |
| Moderate |
PASI 75 PatGA 0,1 |
– | PASI 90 | – |
| Severe |
PASI 75 PASI 50 |
– | DLQI 0,1 | – |
| Mild to moderate |
PASI 50 PASI 75 IGA 0,1 |
– |
PASI 125 PASI 90 IGA 0,1, Reduction ≥ 2 |
– |
| Moderate to severe |
PASI 50 PASI 75 IGA 0,1, Reduction ≥ 2 |
PASI 75 PASI 50 PASI 90 ACR 20 |
PASI 125 DLQI 0,1 NRS-4 |
MDA ACR 70 ACR 50 |
| Not mentioned |
PASI 50 PASI 75 IGA 0,1 |
PASI 75 PASI 50 PASI 90 PsARC |
PASI 125 DLQI 0,1 IGA 0,1, Reduction ≥ 2 |
ACR 70 ACR 50 MDA |
| Type of intervention | ||||
| Antibodies |
PASI 50 PASI 75 IGA 0,1, Reduction ≥ 2 |
PASI 75 PASI 50 PASI 90 ACR 20 |
PASI 125 DLQI 0,1 NRS-4 |
ACR 70 MDA ACR 50 |
| Small molecules |
PASI 50 PASI 75 NRS-4 |
ACR 20 PsARC ACR 50 |
PASI 125 DLQI 0,1 PASI 90 |
PASI 90 ACR 70 MDA |
| Non-biologics |
PASI 75 IGA 0,1 PASI 90 |
PsARC |
PASI 125 DLQI 0,1 |
ACR 50 |
| Application method | ||||
| Topical |
IGA 0,1 PASI 50 PASI 75 |
– |
PASI 125 PASI 90 IGA 0,1, Reduction ≥ 2 |
– |
| Systemic |
PASI 50 PASI 75 IGA 0,1, Reduction ≥ 2 |
PASI 75 PASI 50 PASI 90 PsARC |
PASI 125 DLQI 0,1 NRS-4 |
ACR 70 MDA ACR 50 |
PASI 50: ≥ 50% reduction in the Psoriasis Area and Severity Index (PASI) score from baseline; PASI 75: ≥ 75% reduction in the PASI score from baseline; PASI 90: ≥ 90% reduction in the PASI score from baseline; PASI 125: ≥ 125% of the baseline PASI score; IGA 0,1: Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at endpoint; IGA 0,1, Reduction ≥ 2: IGA score of 0 or 1 with at least a 2-grade improvement from baseline; PatGA 0,1: Patient’s Global Assessment (PatGA) score of 0 (clear) or 1 (almost clear) at endpoint; DLQI 0,1: Dermatology Life Quality Index (DLQI) score of 0–1, indicating no impact on quality of life; NRS-4: ≥ 4-point reduction in Itch Numeric Rating Scale (NRS) from baseline; ACR 20: American College of Rheumatology (ACR) 20% improvement criteria; ACR 50: ACR 50% improvement criteria; ACR 70: ACR 70% improvement criteria; MDA: Minimal Disease Activity; PsARC: Psoriatic Arthritis Response Criteria