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Ultrasonography indicated response to therapy in rheumatoid arthritis
Ultrasonographic measurements of metacarpophalangeal joints were an early, reliable indicator of therapeutic response to treatment for patients with rheumatoid arthritis, according to study results.
Researchers conducted two consecutive 15-day studies of patients who had rheumatoid arthritis (RA) for at least 6 months. In the first study (panel A), eight patients (mean age, 61.6 years; 75% women) were assigned 15 mg prednisone daily and 10 patients (mean age, 58.4 years; 50% women), placebo. In the second study (panel B), 18 patients (mean age, 57.9 years; 66.7% women) were assigned 7.5 mg prednisone daily and nine patients (mean age, 55.1 years; 66.7% women), placebo.
High-frequency and power Doppler ultrasonography in the dorsal transverse and longitudinal planes of all 10 metacarpophalangeal joints (MCPJs) was conducted on days 1 (baseline), 2, 8 and 15 to obtain summated scores of synovial thickness and vascularity. Score in the MCPJs in the transverse plane at day 15 was the primary endpoint. Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) assessed clinical efficacy.
In panel A, comparison between prednisone treatment and placebo groups yielded a statistically significant treatment effect (effect size=1.17, P=.0013) compared with baseline data. The same effect was borderline significant in panel B between the prednisone and placebo cohorts (effect size=0.61, P=.071). The panel A group also showed a significant treatment effect at day 15 for DAS28-CRP (effect size=0.95, P=.032); the panel B group did not.
Ultrasound endpoints measured significant treatment effects at all time points for both panels; the largest observed effect size of 2.33 for the 10 MCP longitudinal synovial thickness area was observed in panel B on day 15. Registration of significant treatment effects improved when ultrasound endpoints and DAS28-CRP were combined.
“Our study confirms that ultrasonographic imaging of MCPJs could be … [an] indicator of a therapeutic response to a new treatment intervention in RA early phase clinical trials with small patient cohorts over a 2-week test period and decrease the time-to-decision for progressing clinical development,” the researchers concluded.
Disclosure: See the study for a full list of relevant disclosures.