Long-term treatment with denosumab increased bone mineral density without any adverse effects in patients with autoimmune liver disease, specifically primary biliary cholangitis, according to the results of a pilot study.
“Osteoporosis is a major complication in patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH),” Yoshitaka Arase, MD, PhD, from the Tokai University School of Medicine in Japan, and colleagues wrote, with a nearly twofold increased risk compared with individuals without PBC.
Denosumab (Prolia, Amgen) increases bone mineral density by inhibiting development and activity of osteoclasts and decreasing bone resorption. Short-term treatment for 1 year previously demonstrated safe and effective outcomes.
To determine long-term outcomes, Arase and colleagues enrolled six patients with PBC and four patients with AIH whose bone mineral density at the lumbar spine was less than 2.5 points below the mean young adult population based on T-scores. All patients were postmenopausal women who received a subcutaneous dose of denosumab every 6 months for 3 years.
The bone mineral density T-scores gradually and significantly improved during the study. Patients also showed significant reductions in serum tartrate-resistant acid phosphatase 5b and alkaline phosphatase 3.
The researchers noted no cases of fresh vertebral fractures or denosumab-related adverse events such as hypocalcemia, atypical femoral fractures and osteonecrosis of the jaw.
“Denosumab has different mechanisms of action and can be used as a first-line treatment or as an alternative to bisphosphonates,” the researchers concluded. “In postmenopausal women with osteoporosis previously treated with oral bisphosphonates, denosumab was well tolerated and increased BMD at all measured skeletal sites and inhibited bone remodeling more effectively compared with once-yearly IV bisphosphonate therapy with zoledronic acid.” – by Talitha Bennett
Disclosures: The authors report no relevant financial disclosures.