Add-Back Therapy: Balancing Efficacy and Safety in Endometriosis

This episode, "Add-Back Therapy: Balancing Efficacy and Safety in Endometriosis," features Dr. Davitt reviewing 12-month efficacy and safety data on add-back therapy.

Dr. Davitt reviews 12-month phase 3 data studying add-back therapy paired with elagolix, which remains FDA-approved only as a monotherapy on its own. He calls the results encouraging: 63% of patients met the dysmenorrhea responder criteria and 51% met the non-menstrual pelvic pain responder criteria while on elagolix with add-back, demonstrating the combination is still effective as a therapy even with add-back layered in. Beyond efficacy, he highlights a meaningful reduction in the drug's effect on bone mineral density, showing that add-back therapy is achieving its intended goal of attenuating bone loss during treatment. Taken together, he sees the data as encouraging on two fronts: the medication remains effective, and the add-back component is successfully mitigating one of its more consequential long-term side effects. The panel then turns to how clinicians evaluate safety profiles of GnRH agonists and antagonists, with and without add-back therapy. The discussion describes reviewing a patient's medical history closely for liver impairment and any history of venous thromboembolism, including deep vein thrombosis or pulmonary embolus, along with any contraindication to the estrogen used in add-back regimens. Dr. Kho also emphasizes assessing a patient's mental well-being as part of that safety evaluation. If a patient reports not feeling emotionally or mentally well, or has recently started an antidepressant or other psychiatric treatment, the panel stresses coordinating with a psychiatrist or psychologist to optimize the patient's mental health before starting one of these hormonal therapies. That combination of liver, clotting, bone, and mental health screening forms the backbone of a thorough pre-treatment safety evaluation, and the panel frames it as a routine part of counseling rather than an occasional afterthought before prescribing.

In "Monitoring Safety and Symptom Relief During Endometriosis Therapy," Dr. Davitt lays out exactly how he monitors patients once therapy is underway.