Home Infusion Administration and Clinical Monitoring Experience of Teprotumumab-trbw in Thyroid Eye Disease (TED) Patients by a Home Infusion Specialty Pharmacy

Objective : Thyroid Eye Disease (TED) is an autoimmune disorder that attacks the muscle and fat tissue behind the eye, causing inflammation with subsequent scar tissue development, leading to proptosis, strabismus, and diplopia. In January 2020, the Food and Drug Administration approved teprotumumab-trbw (Tepezza®) for TED, a monoclonal antibody that blocks the IGF-1R autoantibody, decreases proptosis, and is administered over 8 infusion cycles every 3 weeks. This analysis describes the clinical monitoring experience for patients receiving Tepezza® from this home infusion specialty pharmacy.

Methods: Clinical follow-up of Tepezza® patients in the home infusion arena is conducted by a care team of pharmacists and nurses collaborating with the physician. Using a proprietary clinical database (SoleMetrics®) driven by specific disease and medication assessments, patients are assessed for quality of life (QOL) measures, photos (front, right, left) and therapy outcomes.

Results: Soleo Health has serviced over 400 Tepezza® patients safely in the home. SoleMetrics® uses disease-specific assessments to monitor patients throughout their therapy. Patients are assessed prior to every dispense by either a nurse at the bedside or by a pharmacy clinician with disease state training. The assessment includes medication adherence, efficacy of the therapy, adverse event management, barriers to administration, Graves’ Ophthalmopathy Quality of Life Questionnaire (GO-QOL) Visual Functioning and Appearance Subscales, Soleo Overall Wellness Scale, and patient photos. Trended reports are provided to the prescribing physician as assessments are completed. This provides critical updates to the physician between office visits.
Clinicians identified 76 opportunities for interventions through the assessment process. Interventions are defined as outreaches to the physician based on patient data collected during the assessment process. Interventions were related to dosage optimization based on weight changes, adverse reaction management, therapeutic response, drug interactions, and financial concerns. Interventions resulted in dosage changes, additional or deleted medications, and additional patient counseling or teaching.

Discussion/Conclusion: TED can be devastating for patients creating low self-esteem and poor perception of appearance. Providing the patient and the physician with QOL scores and photo documentation of changes during and after treatment provides the patient with evidence the therapy is working while helping with therapy adherence. Continuous monitoring and collaboration with patients, caregivers, and physicians will ensure optimal patient outcomes.