Table 2.
Long-term outcome and SAE
| Trial agent | Efalizumab [13] | Alefacept [14] | Etanercept [15] | Etanercept [16] | Tofacitinib [20] | Tofacitinib [21] |
|---|---|---|---|---|---|---|
| NCT number | NCT00602823 | NCT00422617 | NCT00245960 | NCT00663052 | NCT01276639 | NCT01815424 |
| Number of treatment courses | 25 | 14 | 15 | 16 | 31 | 14 |
| Follow-up duration (years), median (min–max) | 14.1 (2.5–14.4) | 13.6 (0.3–13.8) | 10.9 (1.2–12.3) | 8.9 (0.1–9.4) | 4.1 (0.2–7.4) | 3.6 (2.9–4.5) |
| Cumulative relapse-free rate at 6 months, % | 0 | 0 | 66.7% | 66.7% | 33.3% | 0 |
| Cumulative relapse-free rate at 12 months, % | 0 | 0 | 50% | 33.3% | 12.5% | 0 |
| New arthritis, n (events/100 PY) | 12 (3.7) | 2 (1.3) | 0a (0) | 3 (2.6) | 4 (3.0) | 5 (10.1) |
| Erythrodermic psoriasis, n (events/100 PY) | 7 (2.2) | 2 (1.3) | 0 (0) | 3 (2.6) | 4 (3.0) | 1 (2.0) |
| Pustular psoriasis, n (events/100 PY) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| SAE, n (events/100 PY) | 4 (1.6) | 2 (1.2) | 4 (2.9) | 2 (1.8) | 1 (0.8) | 0 (0) |
| MACE, n (events/100 PY) | 1 (0.3) | 1 (0.6) | 2 (2.1) | 1 (0.9) | 1 (0.7) | 0 (0) |
| Trial agent | Ixekizumab [22] | Secukinumab [18] | Secukinumab and ustekinumab [19] | Ustekinumab [17] | Ustekinumab and guselkumab [23] | Pooled |
|---|---|---|---|---|---|---|
| NCT number | NCT02513550 | NCT01365455, NCT01544595 | NCT02074982 | NCT00747344 | NCT02203032 | |
| Number of treatment courses | 15 | 34 | 24 | 30 | 14 | 232 |
| Follow-up duration (years), median (min–max) | 2.3 (0.5–2.4) | 2.6 (0.1–7.1) | 3.2 (2.1–4.3) | 9.5 (0.9–9.7) | 3.1 (2.0–3.3) | 4.7 (0.1–14.4) |
| Cumulative relapse-free rate at 6 months, % | 29.2% | 16.7% | 22.2% | 73.3% | 0 | 31.3% |
| Cumulative relapse-free rate at 12 months, % | 9.7% | 11.1% | 0 | 27.5% | 0 | 13.9% |
| New arthritis, n (events/100 PY) | 4 (12.2) | 5 (5.3) | 4 (5.3) | 1 (0.4) | 0 (0) | 40 (2.8) |
| Erythrodermic psoriasis, n (events/100 PY) | 1 (3.9) | 7 (7.4) | 4 (5.3) | 2 (0.7) | 1 (2.4) | 32 (2.2) |
| Pustular psoriasis, n (events/100 PY) | 0 (0) | 0 (0) | 1 (1.3) | 0 (0) | 0 (0) | 1 (0.1) |
| SAE, n (events/100 PY) | 0 (0) | 2 (2.1) | 2 (2.6) | 3 (1.1) | 0 (0) | 21 (1.5) |
| MACE, n (events/100 PY) | 0 (0) | 0 (0) | 2 (2.6) | 3 (1.1) | 0 (0) | 12 (0.8) |
PRESTA inclusion criteria required subjects to be diagnosed with psoriatic arthritis. Long-term outcome and SAE of the trials numbered in Table 1 were collected during and after the administration of biologics. Cumulative relapse-free rates were derived from Kaplan–Meier survival analysis
NCT number clinicaltrials.gov identifier, SAE serious adverse events, MACE major adverse cardiovascular events