ECE2017 Guided Posters Pituitary & endocrine Tumours (12 abstracts)
Introduction: Pegvisomant (PEGV) is approved for the treatment of acromegaly since 2003. This is the second interim analysis of data from ACROSTUDY, with the majority of patients treated for at least five years (yrs).
Methods/design: ACROSTUDY is an international, open-label, prospective, non-interventional, post-marketing surveillance study monitoring the long-term safety and efficacy of PEGV. Patients were enrolled in the study on an ongoing basis.
Results: As of May 31, 2016, data from 2090 patients (51% men) from 15 countries were available. Mean treatment duration was 7.6 yrs (median 8.1 range: 0.019.1 yrs). Patients were followed in ACROSTUDY for a mean of 6.3 yrs (median 6.8, range 0.112.1). At ACROSTUDY start, there were 12 patients in the 018 yrs category and 203 patients in the >70 yrs category. At PEGV start, pituitary insufficiencies were observed for gonadotrophins (37.9%), TSH (29.1%) and ACTH (28.3%). 54.4% of patients experienced adverse events (AEs) with most common AE being IGF-I increased (10.5% of patients), headache(4.9%), vitamin D deficiency(4.6%) and arthralgia(3.7%). SAEs were experienced in 22% of patients (2.3% were treatment related, while 7.0% of patients discontinued treatment due to the SAE). A total of 78 deaths were reported (all non-treatment related). Locally assessed MRIs showed that most patients (72.2%) had no change in tumour size relative to last exam; 16.8% had decrease in tumour size, 6.8% had an increase, and 4.3% had both increase and decrease. Shift analysis demonstrated that of the 1245 with reported normal LFTs (AST/ALT) at baseline, 3% developed elevations > 3xULN. Administration site reactions were reported for 3.4% of patients.
Conclusions: This second interim analysis of long-term follow up showed that PEGV is an effective and safe treatment in patients with acromegaly. Data indicate low occurrence of reported pituitary tumor changes, liver test elevations and site administration reactions.
20 May 2017 - 23 May 2017