Chamberlain C, et al. – The safety and clinical activity of dapirolizumab pegol, a polyethylene glycol conjugated anti–CD40L Fab' fragment, were examined in patients with systemic lupus erythematosus (SLE). Results suggested that dapirolizumab pegol could be an effective biological treatment for SLE. However, further research work was needed to address efficacy and safety.

Methods

• This study evaluated repeated intravenous administration of dapirolizumab pegol in patients with SLE who were positive for/had history of antidouble stranded DNA/antinuclear antibodies and were on stable doses of immunomodulatory therapies (if applicable).
• 16 patients were randomised to 30 mg/kg dapirolizumab pegol followed by 15 mg/kg every 2 weeks for 10 weeks; 8 patients received a matched placebo regimen.
• Randomisation was stratified by evidence of antiphospholipid antibodies.
• After the final dose, patients were followed for 18 weeks.

Results

• No serious treatment–emergent adverse events, thromboembolic events or deaths were reported.
• Adverse events were mild or moderate, transient and resolved without intervention.
• In patients with high disease activity at baseline, efficacy assessments were conducted.
• 5 of 11 (46%) dapirolizumab pegol–treated patients achieved British Isles Lupus Assessment Group–based Composite Lupus Assessment response (vs 1/7; 14% placebo) and 5/12 (42%) evaluable for SLE Responder Index–4 responded by week 12 (vs 1/7; 14% placebo).
• In blood RNA samples, mechanism–related gene expression changes were reported.