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A multicenter, observational study of lanreotide depot/autogel (LAN) in patients with acromegaly in the United States: 2-year experience from the SODA registry

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Abstract

Purpose

This analysis evaluates the 2-year effectiveness and safety of lanreotide depot/autogel (LAN), as well as treatment convenience and acromegaly symptom relief, from the Somatuline® Depot for Acromegaly (SODA) registry, a post-marketing, open-label, observational, multicenter, United States registry study.

Methods

Patients with acromegaly treated with LAN were eligible for enrollment. Demographics, LAN dose, extended dosing interval (EDI) (interval of injections ≥42 days), insulin-like growth factor 1 (IGF-1), growth hormone (GH), glycated hemoglobin, adverse events (AEs), injection convenience, and symptom data were collected.

Results

As of September 29, 2014, 241 patients were enrolled in SODA. IGF-1 levels below age- and gender-adjusted upper normal limit (ULN) were achieved in 71.2% at month (M) 12 and 74.4% at M24; GH ≤2.5 µg/L in 83.3% at M12 and 80.0% at M24; GH <1.0 µg/L in 61.7% at M12 and 61.4% at M24. Both IGF-1 < ULN and GH ≤2.5 µg/L were achieved in 65.0% at M12 and 54.8% at M24; both IGF-1 < ULN and GH < 1.0 µg/L were achieved in 51.7 and 42.9% at M12 and M24, respectively. EDI regimen was 5.0% at baseline and 12.0% at M24. At M24, acromegaly symptoms appeared stable or improved. The most common AE was arthralgia (25.7%). Among 106 serious AEs reported by 42 patients, 10 were deemed related to therapy in 9 patients. At M24, 73.1% of patients rated LAN as convenient.

Conclusions

SODA indicates 2-year biochemical control with majority of patients achieving both IGF-1 < ULN and GH ≤2.5 µg/L. LAN was generally well tolerated with no new or unexpected safety signals reported during the observation period.

clinicaltrials.gov Clinical Trial Identifier: NCT00686348

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Acknowledgements

The authors wish to thank the patients and investigators of each participating center in this study. The authors also thank Olga V. Gambetti, formerly of Ipsen Biopharmaceuticals, Inc., for her assistance with this study and Kathleen Allen, study manager. Sarah Mizne, PharmD and Lynanne McGuire, PhD, of MedVal Scientific Information Services, LLC, provided professional writing and editorial assistance which was funded by Ipsen Biopharmaceuticals, Inc. This manuscript was prepared according to the International Society for Medical Publication Professionals’ “Good Publication Practice for Communicating Company-Sponsored Medical Research: the GPP3 Guidelines” and the International Committee of Medical Journal Editors’ “Uniform Requirements for Manuscripts Submitted to Biomedical Journals.”

Funding

This study was sponsored by Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ.

Author information

Authors and Affiliations

  1. Division of Endocrinology, Diabetes and Metabolism, and Pituitary Center, Johns Hopkins University, 1830 East Monument Street #333, Baltimore, MD, 21287, USA

    Roberto Salvatori

  2. Allegheny Neuroendocrinology Center, Division of Endocrinology, Allegheny General Hospital, 420 E North Avenue, Suite 205, Pittsburgh, PA, 15212, USA

    Murray B. Gordon

  3. Division of Endocrinology, Diabetes and Hypertension, Brigham’s and Women’s Hospital, 221 Longwood Avenue, Boston, MA, 02115, USA

    Whitney W. Woodmansee

  4. Department of Medicine, Division of Endocrinology, Metabolism and Lipids and Department of Neurosurgery, Emory University School of Medicine, 1365 B Clifton Road, NE, B6209, Atlanta, GA, 30322, USA

    Adriana G. Ioachimescu

  5. Ipsen Biopharmaceuticals, Inc. Statistician Consultant, 106 Allen Road, Basking Ridge, NJ, 07920, USA

    Don W. Carver

  6. Medical Affairs, Ipsen Biopharmaceuticals, Inc., 106 Allen Road, Basking Ridge, NJ, 07920, USA

    Beloo Mirakhur & David Cox

  7. Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, 645 North Michigan Avenue, Suite 530, Chicago, IL, 60611, USA

    Mark E. Molitch

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  1. Roberto Salvatori
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Contributions

All authors contributed equally and each was involved in study design, data acquisition, or data analysis/ interpretation and in drafting or critically revising the manuscript. All authors reviewed the final manuscript and gave approval for submission.

Corresponding author

Correspondence to Roberto Salvatori.

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Conflict of interest

Roberto Salvatori: Consultant/Advisory Board: Pfizer, Ionis Pharmaceutical, Novo Nordisk, Novartis; Research support: Ipsen, Novartis, Pfizer, Novo Nordisk, Chiasma, Millendo, Strongbridge, Prolor. Murray B. Gordon: Research support: Ipsen, Chiasma, Novartis, Novo Nordisk, Opko, Pfizer, Strongbridge, Teva. Whitney W. Woodmansee: Clinical trial investigator: Ipsen, Novo Nordisk, Versartis, Pfizer; Consultant/Advisory Board: Corcept, Genentech, Ipsen. Adriana G. Ioachimescu: Research support: Novartis, Ipsen, Chiasma, Pfizer; Consultant/Advisory Board: Chiasma, Ionis, and Ipsen. Beloo Mirakhur and David Cox: Full-time employees: Ipsen Biopharmaceuticals, Inc. Don W. Carver: Ipsen consultant. Mark E. Molitch: Research support: Ipsen, Novartis, Bayer, Prolor, Novo Nordisk, Johnson and Johnson; Consultant: Corcept, Ipsen, Novartis, Novo Nordisk, Merck, Pfizer.

Informed consent

All eligible patients signed a statement of informed consent, and the day on which the informed consent form was signed was considered the enrollment date.

Research involving human participants

The SODA study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice Guidelines, current Food and Drug Administration regulations and guidelines, local ethical and legal requirements, and the United States Code of Federal Regulations and the Health Insurance Portability and Accountability Act for the collection, transmission, and storage of study data. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Statement on the welfare of animals

This article does not contain any studies with animals performed by any of the authors.

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Salvatori, R., Gordon, M.B., Woodmansee, W.W. et al. A multicenter, observational study of lanreotide depot/autogel (LAN) in patients with acromegaly in the United States: 2-year experience from the SODA registry. Pituitary 20, 605–618 (2017). https://doi.org/10.1007/s11102-017-0821-y

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