Adalimumab effectively reduces the signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis.

Abstract

OBJECTIVE:

To evaluate the long-term safety and efficacy of adalimumab in patients with ankylosing spondylitis (AS) and total spinal ankylosis (TSA).

DESIGN:

Patients (n = 315) with active AS were randomised in a 2:1 ratio to receive adalimumab 40 mg every other week or placebo for 24 weeks followed by open-label adalimumab for up to 5 years. Two-year efficacy and safety data for 11 patients with investigator-defined TSA were evaluated. The primary end point was the ASsessment in AS International Working Group criteria for 20% improvement (ASAS20) at Week 12. On or after Week 12, ASAS20 non-responders could switch to open-label adalimumab. Other efficacy measurements included ASAS40, ASAS 5/6, ASAS partial remission, and 50% improvement in the Bath AS Disease Activity Index (BASDAI 50).

RESULTS:

6 of 11 TSA patients were randomised to adalimumab and 5 to placebo. At Week 12, 50% of the adalimumab-treated patients achieved an ASAS20 response and 33% achieved an ASAS40, ASAS 5/6 and BASDAI 50. No placebo-treated patients achieved any response criteria at Week 12. 4 placebo- and 2 adalimumab-treated patients switched to open-label adalimumab before Week 24. After 1 year of adalimumab treatment, 8 of 11 patients achieved an ASAS20 response. After 2 years, 6 of the remaining 8 patients with TSA reported an ASAS20 response. There were no serious adverse events or adverse event-related study discontinuations.

CONCLUSION:

In patients with TSA, adalimumab treatment resulted in rapid and clinically significant improvement in the signs and symptoms of active disease. Adalimumab effectiveness and safety were sustained for at least 2 years.

TRIAL REGISTRATION NUMBER:

NCT00085644.

• Authors: D van der Heijde, A L Pangan, M H Schiff, J Braun, M Borofsky, J Torre, J C Davis Jr, R L Wong, H Kupper, E Collantes, ATLAS Study Group
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 67 Issue 9 Pg. 1218-21 (Sep 2008) ISSN: 1468-2060 [Electronic] England
• PMID: 18056755 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antirheumatic Agents
• Tumor Necrosis Factor-alpha
• Adalimumab

Topics

• Adalimumab
• Adult
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antirheumatic Agents (adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Severity of Illness Index
• Spondylitis, Ankylosing (drug therapy)
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors)