ArticlePituitary2026
Long-term safety and efficacy of pegvisomant monotherapy for acromegaly: final data from the full ACROSTUDY cohort.
Article in Pituitary, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Pasireotide-LAR and pegvisomant combination in resistant acromegaly: a case series of predominantly mammosomatotroph adenomas.Pituitary · 2026Article
- Development and characterization of a long-acting allosteric growth hormone receptor antagonist for acromegaly.Endocrinology · 2026Article
- Letter to the editor: Long-term safety and efficacy of pegvisomant monotherapy for acromegaly: final data from the full ACROSTUDY cohort.Pituitary · 2026Article
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Authors and funding
11 authors.
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No grant is acknowledged in the PubMed record.
Abstract
purposeACROSTUDY was an international, non-interventional, cross-sectional study that evaluated the long-term safety and treatment outcomes of pegvisomant treatment (monotherapy or combination) in patients with acromegaly in “real-world” clinical practice. This study aimed to characterize the long-term safety and efficacy of pegvisomant monotherapy in ACROSTUDY.
methodsPatients with acromegaly aged > 18 years (at ACROSTUDY enrollment) who had received ≥ 1 dose of pegvisomant as monotherapy were included in the monotherapy cohort. Clinical assessments included adverse events (AEs), comorbidities, pituitary imaging, liver function tests, and insulin-like growth factor-1 (IGF-I) serum measurements.
resultsPatients with acromegaly (N = 1464) received pegvisomant monotherapy for a median (min, max) of 6.0 (0.0, 19.3) years and were followed in ACROSTUDY for a mean of 7.6 years. The rates of AEs (all-causality) and serious AEs were 49% (n = 717/1464) and 19.3% (n = 282/1464), respectively. The most common treatment-related AEs were IGF-I increased (1.8%), lipohypertrophy (1.2%), transaminases increased (1.2%), and IGF-I decreased (1.1%). There were 31 (2.1%) deaths and none were related to treatment. Magnetic resonance imaging findings at study sites showed 7.2% (n = 90/1248) of patients had increased tumor size, whereas 70.6% (n = 881/1248) of patients had change in tumor size. At the last observation, the serum IGF-I normalization rate was 62.3% (n = 756/1213) and the median (min, max) daily pegvisomant dose was 15.0 (0, 60) mg/day.
conclusionsIn this largest and longest real-world study of pegvisomant monotherapy in patients with acromegaly to date, pegvisomant demonstrated a favorable safety profile and was effective at normalizing and maintaining IGF-I levels in the majority of patients.
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