ECE2017 Guided Posters Pituitary & endocrine Tumours (12 abstracts)
Long-term treatment with pegvisomant (Somavert®): Observations from 2090 acromegaly patients followed in ACROSTUDY
Aart Jan vanderLely 1 , Beverly Biller 2 , Thierry Brue 3 , Michael Buchfelder 5 , Ezio Ghigo 4 , kaijie Pan 8 , Peter Jonsson 9 , Joanne Lavenberg 8 , Christian J. Strasburger 6 , Susan Webb 7 , Cecilia Camacho-Hubner 8 & Judith Hey-Hadavi 8
1Erasmus University Medical Center, Rotterdam, The Netherlands; 2Massachusetts General Hospital, Boston, MA, USA; 3Universite de la Mediterranee, Marseille, France; 4Universita de Torino, Torino, Turin, Italy; 5University of Erlangen-Nurnberg, Erlangen, Germany; 6Charite-Universitatsmedizin, Berlin, Germany; 7Universitat Autonoma de Barcelona, Barcelona, Spain; 8Pfizer Inc Endocrine Care, New York-Collegeville, USA; 9Pfizer Inc ACROSTUDY Endocrine care, Sollentuna, Sweden.
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: 0.0–19.1 yrs). Patients were followed in ACROSTUDY for a mean of 6.3 yrs (median 6.8, range 0.1–12.1). At ACROSTUDY start, there were 12 patients in the 0–18 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.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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