ECE2020 Audio ePoster Presentations Pituitary and Neuroendocrinology (217 abstracts)
Efficacy and safety of long-acting pasireotide (LA-PAS) in patients with uncontrolled acromegaly: Results from the prospective cohort of european observational acronis study
Rosario Pivonello 1 , Antoine Tabarin 2 , Annamaria Colao 1 , Gregory Kaltsas 3 , Inmaculada Gonzalez-Molero 4 , Sebastian Neggers 5 , Eva Venegas Moreno 6 , Tomaz Kocjan 7,8 , Wolfram Karges 9 , Katarzyna Krzyzanowska-Mittermayer 10 , Ansgar Heck 11 , Britt Eden Engstrom 12 , Ruben Marques 13,14 , Eamonn O’Brien 15 , Shobha Manne 16 , Beatrice Vincenzi 13 & Christof Schöfl 17
1Universita’ Federico II di Napoli, Naples, Italy; 2CHU de Bordeaux, Bordeaux, France; 3General Hospital of Athens Laiko, Athens, Greece; 4Hospital Regional Universitario de Málaga, Málaga, Spain; 5Erasmus MC-Sophia Children’s Hospital, Rotterdam, Netherlands; 6Campus Del Hospital Universitario Virgen del Rocio, Sevilla, Spain; 7University Medical Centre Ljubljana, Ljubljana, Slovenia; 8Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; 9RWTH Aachen University, Aachen, Germany; 10Rudolfstiftung Hospital, Vienna, Austria; 11Oslo University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway; 12Uppsala University Hospital, Uppsala, Sweden; 13Novartis Farma S.p.A, Origgio, Italy; 14Institute of Biomedicine (IBIOMED), University of Leon, León, Spain; 15Novartis Ireland Limited, Dublin, Ireland; 16Novartis s.r.o, Prague, Czech Republic; 17Endokrinologie im Zentrum, Bamberg, Germany
Introduction: Results of the first European real-world evidence from retrospective cohort of ACRONIS study previously confirmed the efficacy and tolerability of LA-PAS in heavily pre-treated, uncontrolled acromegaly patients. Here, we report results of the second interim analysis reflecting the prospective cohort.
Methods: Patients who were treated with LA-PAS for ≥6 months were included in this analysis. The primary objective was to document treatment efficacy, defined by the proportion of patients who achieved IGF-1 level normalization <1 upper limit of normal (ULN) and GH <1 µg/l at 6 months of LA-PAS treatment. Key secondary objectives were changes from baseline in standardized IGF-1 and GH levels, proportion of patients with IGF-1 normalization and GH normalization over time, overall safety and tolerability of LA-PAS.
Results: On 13 Sep 2019, 112 of 200 enrolled patients completed 6 months LA-PAS treatment. Among these, 94 and 109 were included in efficacy and safety analysis, respectively. The mean age of the patients was 50.1 years; 51.1% were male. Median time since diagnosis was 66.5 months; 73.4% had previous surgery and 19.1% had radiotherapy; 98.9% had taken prior medication, mainly first-generation SSAs (58.5% octreotide, 61.7% lanreotide), growth hormone receptor antagonists (38.3%) or dopamine agonists (37.2%) as mono- or combination therapy. In the safety analysis set, 22.0% and 37.6% of patients were diabetic or pre-diabetic prior to LA-PAS prescription, respectively. IGF-1 normalization <1 ULN and random GH <1 µg/l was achieved in 31.9% (95% CI, 21.4–43.9) of patients and IGF-1 normalization <1 ULN and random GH <2.5 µg/l in 44.4% (95% CI, 32.7–56.6) at 6 months. Median (95% CI) percentage reductions from baseline in IGF-1 and GH were 34.3% (43.0–27.6) and 66.8% (73.4–52.9) at 6 months, respectively. IGF-1 normalization (<1 µg/l and <1.3 µg/l) was achieved in 51.8% (40.6–62.9) and 72.3% (61.4–81.6) at 6 months. After median exposure of 22.1 months (range 5.9–29.8), 68.8% remained on starting dose, 22% were up-titrated once, 4.6% were down-titrated once and 4.6% required multiple dose changes. The most common adverse events (AEs in >10%) reported were hyperglycemia (21.1%), diagnosed diabetes mellitus (12.8%) and diarrhea (10.1%). One patient reported permanent discontinuation of LA-PAS due to Grade 2 hyperglycemia.
Conclusion: Findings from this prospective ACRONIS dataset confirm the efficacy of LA-PAS in previously uncontrolled acromegaly patients and are in agreement with those reported in a previous randomized trial (Gadelha, et al. Lancet Diabetes Endocrinol. 2014). The safety of LA-PAS was consistent with its known profile.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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