PROLIA (denosumab), monoclonal antibody

High clinical benefit in post-menopausal osteoporosis only in 2nd line but no clinical benefit demonstrated in the therapeutic strategy

• The reimbursable indication for PROLIA in the treatment of post-menopausal osteoporosis remains reserved for women at high risk of fractures, and in 2^nd line, as follow-on treatment from bisphosphonates.

• As superiority to other available treatments has not been demonstrated in terms of anti-fracture efficacy, as its safety profile includes osteonecroses and atypical fractures, multiple vertebral fractures occurring on treatment discontinuation (rebound effect) and unknown elements relating to real-life compliance, PROLIA no longer demonstrates clinical benefit in the therapeutic strategy.

• Where denosumab is to be discontinued, an anti-resorber should be planned to minimise the rebound effect.