Abstract

Pegvisomant monotherapy is effective and safe in treatment of acromegaly. However, some clinicians combine pegvisomant with somatostatin analogues (SSA) or dopamine agonist (DA). In this analysis of ACROSTUDY, a long-term non-interventional study, the use of combination regimens was evaluated. Based on their baseline treatment, 2043 patients were retrospectively categorized as: long-acting SSA combined with pegvisomant, ‘Combo SSA’ 768 patients (38%); DA combined with pegvisomant, ‘Combo DA’ 123 (6%); pegvisomant monotherapy, ‘Peg mono’ 1128 (55%). Treatment patterns changed over the 10-year period, with recent patients more likely to receive any combination (20% in 2003 vs 54% in 2012). Combo SSA use varied widely among countries from 22% to 78%. Exposure periods of the three treatment modalities were defined from pegvisomant start until the last visit in ACROSTUDY; patients could switch treatment categories. At year 4, IGF-I was normal in 62% of Combo SSA, 63% of Combo DA and 65% of Peg mono groups. Pegvisomant was initiated as daily injections in 94% of patients in the Peg mono group, 66% of Combo SSA and 91% of Combo DA patients. During 6169 years of treatment exposure, 3424 adverse events (AEs) were reported in 946 (51%) patients, of which 617 (18%) were serious and 401 (12%) were considered treatment related. The reported incidence of serious AEs and treatment-related non-serious AEs were similar among the three treatment modalities. This analysis describes real-world clinical care and shows favorable efficacy and safety for Peg mono and combinations. Novel findings include an increased use of combination therapy over time and variability in treatment modalities between countries.

Highlights

  • While pituitary surgery remains the first-line treatment for acromegaly, medical therapy is needed for about 50% of patients who are not cured by surgery alone [1, 2, 3]

  • The percentages of patients remaining in their original treatment category at seven years after pegvisomant start were: Combo somatostatin analogues (SSA) 44%, Combo dopamine agonists (DA) 38% and Peg mono 64% (Supplementary Table 1, see section on supplementary data given at the end of this article)

  • The present analysis evaluated the long-term safety and efficacy of three different medical treatment approaches in patients with acromegaly being followed in ACROSTUDY

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Summary

Introduction

While pituitary surgery remains the first-line treatment for acromegaly, medical therapy is needed for about 50% of patients who are not cured by surgery alone [1, 2, 3]. IGF-I levels in 63–97% of patients [4, 5, 6, 7]. The efficacy of SSA monotherapy varies, and it has been reported that 17–55% of acromegaly patient had normal IGF-I levels on this treatment [8, 9, 10, 11]. Patients who do not demonstrate a satisfactory response to SSA treatment may be switched to pegvisomant monotherapy [4].

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