Clinical studies of anti-TNFα agents in SpA/AS
| Study | Site design | Study | Patients (n) | Age (y) | Disease duration (y) | Dose | Treatment duration | Outcome parameters | % Reduction in median BASDAI score |
|---|---|---|---|---|---|---|---|---|---|
| *All patients with AS had total ankylosis. | |||||||||
| †Median improvement in BASFI. | |||||||||
| AS, ankylosing spondylitis; ASAS, Assessments in Ankylosing Spondylitis; ASQoL, Ankylosing Spondylitis Quality of Life; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASGI, Bath Ankylosing Spondylitis Global Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; IV, intravenous; MRI, magnetic resonance imaging; NRS, numerical rating scale; OL, open label trial; QoL, quality of life; RCT, randomised controlled trial; SC, subcutaneous; SF-36, Short Form Health Survey 36; SJC, swollen joint count; SpA, spondyloarthritis; TJC, total joint count; VAS, visual analogue scale. | |||||||||
| Infliximab | |||||||||
| Brandt et al, 200040 | Berlin, Germany | OL | AS (11) | 36 (mean) | 5 (median) | 5 mg/kg IV at weeks 0, 2, and 6 | 3 mo | • Clinical/functional assessments (e.g., BASDAI, BASFI, BASMI) | 63% (12 wk) |
| • QoL assessment (SF-36) | |||||||||
| • Inflammatory markers | |||||||||
| • MRI | |||||||||
| Van den Bosch et al, 200042 | Ghent, Belgium | OL | SpA (21) [AS (11)] | 49 (median) | 17 (median) | 5 mg/kg IV at weeks 0, 2, and 6 | 84 d, plus 1 y follow up | • Global disease activity assessments | 82% (84 d) |
| • Axial assessments (e.g., BASDAI, BASFI, BASMI) | |||||||||
| • Peripheral arthritis assessments (e.g., TJC, SJC) | |||||||||
| Stone et al, 200145 | Toronto, Canada | OL | AS (21) | 38 (median) | 9 (median) | 5 mg/kg IV at weeks 0, 2, and 6 | 14 wk | • Clinical/functional assessments (e.g., BASDAI, BASFI) | 93% (14 wk) |
| • Clinimetrics | |||||||||
| • Inflammatory markers | |||||||||
| • MRI | |||||||||
| Spanish Spondyloarthritis Study Group, 200246 | Spain | OL | SpA (26) [AS* (18)] | 44 (mean) | 15 (mean) | 5 mg/kg IV at weeks 0, 2, 6, 14, 22, and 30 | 30 wk | • Clinical/functional assessments (e.g., BASDAI, BASFI, pain VAS) | 57% (14 wk); 45% (30 wk); (p<0.001 at both end points) |
| • QoL assessment (SF-36) | |||||||||
| • Inflammatory markers | |||||||||
| Breban et al, 200247 | France | OL | AS (50) | 36 (mean) | 15 (mean) | 5 mg/kg IV at weeks 0, 2, and 6 | 6 mo | • Global disease activity assessments | 76% (8 wk) |
| • Clinical/functional functional assessments (e.g., BASDAI, BASFI, pain VAS) | |||||||||
| • Inflammatory markers | |||||||||
| Maksymowych et al, 200248 | Canada RCT | 21 (AS) | 42.5 (mean) | 13.8 (mean) | 3 mg/kg IV at weeks 0, 2, and 6, then q 2 mo | 52 WK | • Clinical /functional assessments (BASDAI, BASFL, BASGI, BASMI) | 54.85% (mean 14 wk; p<0.001) | |
| • MRI (6 patients) | |||||||||
| Braun et al, 200249 | Germany | RCT/OL | AS (70) | 39 (mean) | 15 (median) | 5 mg/kg IV at weeks 0, 2, and 6, then q 6 wk | 54 wk (OL) | • Clinical/functional assessments (e.g., BASDAI, BASFI, BASMI, ASAS, pain NRS) | 49% v 10% (mean values at 12 wk; p<0.0001); 56% (54 wk), p<0.0001 |
| 12 wk (RCT) | • QoL assessment (SF-36) | ||||||||
| • Inflammatory markers | |||||||||
| Van den Bosch et al, 200251 | Belgium | RCT/OL | SpA (40) [AS (19)] | 47.3 (placebo) | 8 (placebo) | 5 mg/kg IV at weeks 0, 2, and 6, then q 6 wk | 12 wk (RCT) | • Global disease activity assessments | 86% v 18% (8 wk); (p=0.002, infliximab v placebo) |
| 6.5 (infliximab) | 54 wk (OL) | 46 (infliximab) | • Clinical functional assessments (e.g., BASDAI, BASFI, pain VAS)55% v 5% (12 wk); (p=0.002, infliximab v placebo) | ||||||
| • Inflammatory markers | |||||||||
| Etanercept | |||||||||
| Marzo-Ortega et al, 200052 | UK | OL | SpA (10) [AS (7)] | 37 (mean) | 12 (mean) | 25 mg SC twice weekly | 6 mo | • Global disease activity assessments | 79% |
| • Clinical/functional assessments (e.g., BASDAI, BASFI, spinal pain VAS) | |||||||||
| • Entheseal counts | |||||||||
| • Peripheral arthritis assessments (e.g., TJC, SJC) | |||||||||
| • QoL assessment (ASQoL) | |||||||||
| • MRI | |||||||||
| Gorman et al, 200253 | US | RCT, OL | AS (40) | 39 (mean) | 14 (mean) | 25 mg SC twice weekly | 4 mo (RCT) 6 mo (OL) | • Global disease activity assessments | 51% v 3% (4 mo)†; (p=0.001 etanercept v placebo) |
| • Clinical/functional assessments (eg, BASFI, ASAS, morning stiffness, spinal mobility, nocturnal spinal pain VAS) | |||||||||
| • Peripheral arthritis assessments (e.g., TJC, SJC) | |||||||||
| • Modified Enthesopathy Index | |||||||||
| • QoL assessment (SF-36) | |||||||||