Table 1.
Percentage of patients with ANA and anti-dsDNA autoantibody seroconversion in the ATTEST and AMPLE trials [62]
| Seropositive (baseline negative to post-baseline positive) | Seronegative (baseline positive to post-baseline negative) | |||||
|---|---|---|---|---|---|---|
| ATTEST | IV ABA + MTX | IFX + MTX | IV ABA + MTX | IFX + MTX | ||
| ANA | DB perioda | Month 6 | 1.7 (2/115) | 32.2 (38/118) | 37.5 (12/32) | 22.2 (8/36) |
| Year 1 | 6.5 (7/107) | 47.7 (51/107) | 46.7 (14/30) | 11.4 (4/35) | ||
| OLEb | ABA-to-ABA | IFX-to-ABA | ABA-to-ABA | IFX-to-ABA | ||
| Year 1 (baseline) | 6.1 (6/98) | 48.5 (48/99)c | 48.0 (12/25) | 12.1 (4/33)c | ||
| Year 2 | 14.6 (14/96) | 22.4 (22/98)c | 40.7 (11/27) | 20.6 (7/34)c | ||
| Anti-dsDNA | DB perioda | Month 6 | 0.8 (1/128) | 38.6 (51/132) | 20.0 (2/10) | 21.4 (3/14) |
| Year 1 | 2.4 (3/127) | 47.7 (61/128) | 25.0 (2/8) | 7.1 (1/14) | ||
| OLEb | ABA-to-ABA | IFX-to-ABA | ABA-to-ABA | IFX-to-ABA | ||
| Year 1 (baseline) | 2.5 (3/118) | 48.3 (57/118)c | 16.7 (1/6) | 7.1 (1/14)c | ||
| Year 2 | 2.6 (3/114) | 13.3 (15/113)c | 37.5 (3/8) | 33.3 (5/15)c | ||
| AMPLE | SC ABA + MTX | ADA + MTX | SC ABA + MTX | ADA + MTX | ||
| ANA | Year 1 | 5.2 (12/229) | 13.3 (28/210) | 31.9 (23/72) | 18.1 (17/94) | |
| Year 2 | 6.3 (12/190) | 14.7 (24/163) | 45.0 (27/60) | 18.5 (15/81) | ||
| Anti-dsDNA | Year 1 | 0.3 (1/299) | 9.9 (29/293) | 100.0 (1/1) | 60.0 (3/5) | |
| Year 2 | 0 (0/248) | 12.2 (29/237) | 100.0 (1/1) | 75.0 (3/4) | ||
Reproduced from Buch H, et al. Ann Rheum Dis. 2015;74(Suppl 2):1053–4, copyright 2015, with permission from BMJ Publishing Group Ltd. Data are % (n/N)
ABA abatacept, ADA adalimumab, AMPLE Abatacept versus adaliMumab comParison in bioLogic-naïvE rheumatoid arthritis subjects with background methotrexate, ANA antinuclear antibodies, anti-dsDNA anti-double-stranded deoxyribonucleic acid, ATTEST Abatacept or infliximab versus placebo, a Trial for Tolerability, Efficacy and Safety in Treating rheumatoid arthritis, DB double blind, IFX infliximab, IV intravenous, MTX methotrexate, OLE open-label long-term extension, SC subcutaneous
aIntent-to-treat population
bOnly patients who entered the OLE
cPatients switched to IV ABA + MTX