Strasburger C, et al. - Researchers investigated the efficacy of combine pegvisomant monotherapy (Peg mono) with somatostatin analogues (SSA) or dopamine agonist (DA) in the treatment of acromegaly with the GH receptor antagonist pegvisomant. They demonstrated favorable efficacy and safety for Peg mono and combinations. Novel findings included an increased use of combination therapy over time and variability in treatment modalities between countries.

Methods

• This long-term non-interventional study (ACROSTUDY) evaluated the use of combination regimens.
• Researchers retrospectively categorized 2,043 patients based on their baseline treatment:
  • 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%).

Results

• Over the 10 year period, treatment patterns changed, with recent patients more likely to receive any combination (20% in 2003 vs 54% in 2012).
• Among countries, combo SSA use varied widely from 22% to 78%.
• Researchers defined exposure periods of the 3 treatment modalities from pegvisomant start until the last visit in ACROSTUDY; patients could switch treatment categories.
• IGF-I was normal in 62% of Combo SSA, 63% of Combo DA and 65% of Peg mono groups at year 4.
• They initiated pegvisomant as daily injections in 94% of patients in the Peg mono group, 66% of Combo SSA and 91% of Combo DA patients.
• A total of 3,424 adverse events (AEs) were reported in 946 (51%) patients during 6,169 years of treatment exposure.
• Out of them, 617 (18%) were serious and 401 (12%) were considered treatment-related.
• Among the 3 treatment modalities, the reported incidence of serious AEs and treatment-related non-serious AEs were similar.