A new non-steroidal treatment brings new hope to lupus patients
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A breakthrough trial on dapirolizumab pegol known as PHOENYCS GO demonstrated significantly improved lupus disease management and reduced symptoms like fatigue while allowing for a reduction in steroid use. According to one of the study designers and middle author for the PHOENYCS GO Study Investigators’ Group, Professor Eric Morand, a Sir John Monash Distinguished Professor and Head of Rheumatology at the School of Clinical Sciences at Monash Health and Director of Rheumatology at Monash Health, the phase 3 trial published in the Lancet was focused on patients with moderate-to-severe disease activity who were not seeing sufficient results from standard treatments.
Lupus is a chronic autoimmune disease where the body’s immune system switch is always turned on, causing the body to attack its own healthy tissues and organs. Dapirolizumab pegol acts like a guard that blocks one of these key switches, called the CD40 ligand. By blocking this switch, this novel drug helps prevent the over-activation of the immune cells that cause the most damage in lupus.
Prof Eric Morand
A significant breakthrough with dapirolizumab pegol is its design. While older versions of similar drugs accidentally caused dangerous blood clots, dapirolizumab pegol was engineered specifically to avoid this risk by removing the part of the molecule that triggered those clots.
The trial followed 321 patients across 25 countries for almost a year. Two-thirds of the group received dapirolizumab pegol via an IV every four weeks, while the other received a placebo. By the end of the 48-week study, 50 percent of patients taking dapirolizumab pegol saw a major improvement in their disease activity, fewer flare ups and a “meaningful” improvement in fatigue levels. This has led to patients successfully lowering their dose of steroids, potentially sparing them from long-term organ damage.
While dapirolizumab pegol was generally well-tolerated, patients taking it had a slightly higher chance of developing mild infections like a common cold or urinary tract infections. A small number of patients (3 percent) also had mild allergic-type reactions. The researchers concluded that although dapirolizumab pegol significantly improves lupus symptoms and offers a promising new way to treat the disease, more research is necessary.
“To ensure long-term safety, an “open-label extension” study called PHOENYCS GLIDE is currently being conducted to confirm these findings and ensure that dapirolizumab pegol remains safe and effective over several years”, said Professor Morand.