Clinical outcomes after second injection among subjects with moderate or greater target joint swelling at the time of second injection who received 2 doses of rAAV2-TNFR:Fc.
| Dose Escalation | Phase 2 Expansion | |||||
|---|---|---|---|---|---|---|
| 1 × 1011, N = 8 | 1 × 1012, N = 8 | 1 × 1013, N = 6 | 1 × 1011, N = 11 | 1 × 1012, N = 11 | 1 × 1013, N = 11 | |
| AAV2-neutralizing titers prior to 2nd injection, geometric mean | 1/45 | 1/861 | 1/8192 | 1/56 | 1/2181 | 1/903 |
| Change in target joint assessment 12 weeks after 2nd injection | ||||||
| 2-point or greater decrease in target joint swelling, n (%) | 0 | 0 | 0 | 0 | 1 (9) | 2 (18) |
| 2-point or greater decrease in target joint tenderness, n (%) | 1 (13) | 0 | 1 (17) | 4 (36) | 3 (27) | 3 (27) |
| Change in target joint patient-reported outcomes 12 weeks after 2nd injection | ||||||
| 30% or greater improvement in target joint global VAS, n (%) | NT | NT | NT | 2 (18) | 6 (55) | 6 (55) |
| 30% or greater improvement in target joint function VAS, n (%) | NT | NT | NT | 2 (18) | 6 (55) | 5 (45) |
| 2-point or greater decrease in target joint pain, n (%) | NT | NT | NT | 0 | 2 (18) | 2 (18) |
NT: not tested.