Endocrine Abstracts

Background: The SAGIT^® instrument, designed to assist clinicians in staging and managing acromegaly, is undergoing validation. A descriptive analysis of SAGIT Validation study baseline data revealed discrepancies between investigator-evaluated disease-control status, disease activity, hormonal control, and treatment decisions in acromegaly.

Objective: To describe the baseline characteristics of patients in the SAGIT^® validation study.

Methods: Patients with acromegaly were enrolled in a 2-yr prospective non-interventional study in 9 countries (NCT02539927). Investigators determined acromegaly control status at baseline (clinical global evaluation of disease control [CGE-DC]). The study aimed to recruit evaluable controlled and non-controlled patients (n=82 per group). Data collection included: demographic and baseline disease characteristics; medical/surgical histories; concomitant acromegaly treatments; investigators’ evaluation of clinical activity of the disease; growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels; and investigators’ therapeutic decision (preferred intention: continue current treatment[s] with no change/no treatment initiation; intensify current treatment[s]/initiate a treatment; decrease the current treatment[s]; other). Patients were considered naïve to treatment if they had no previous pituitary surgery, radiotherapy, or medications for acromegaly.

Results: Of 228 patients enrolled, CGE-DC status was controlled in 110 (48.2%), not controlled in 105 (46.1%), and yet to be clarified in 13 (5.7%). All CGE-DC controlled patients had received prior treatment, while 31 patients were treatment naïve (not controlled, n=29; yet to be clarified, n=2). Investigators considered 48.2% patients in the controlled and 95.2% in the not controlled subgroups to have clinically active disease. In the controlled subgroup, 29.7% of patients did not exhibit hormonal control (GH ≤2.5 μg/L; normalized IGF-1) and 47.3% did not have strict hormonal control (GH <1.0 μg/L; normalized IGF-1). In the CGE-DC not controlled group, these proportions were 93.1% and 98.0%, respectively. In the CGE-DC controlled group, acromegaly treatment was continued with no change in 91.8%, intensified/initiated in 2.7%, and decreased in 5.5%. In the not controlled group, treatment was continued with no change in 40.0%, intensified/initiated in 58.1%, and ‘other’ for 1.9%.

Conclusion: These real-world findings suggest that opportunities to take active therapeutic decisions in patients with acromegaly may be missed, including in a number of patients with not controlled disease for whom no treatment change was made. Although there may be multifaceted reasons for lack of action, better tools to assist clinical decision making may make a difference for patients.