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Endocrine Abstracts (2021) 73 PEP8.1 | DOI: 10.1530/endoabs.73.PEP8.1


1Leiden University Medical Center (LUMC), Netherlands; 2Oregon Health and Science University, USA; 3M.F. Vladimirsky Moscow Regional Research Clinical Institute, Russian Federation; 4Novosibirsk State Medical University, Russian Federation; 5Interregional Clinical Diagnostic Center, Russian Federation; 6Northwestern University Feinberg School of Medicine, USA; 7University of Belgrade, Serbia; 8Antrium Multidisciplinary Medical Clinic, Russian Federation; 9Hospices Civils de Lyon, France; 10 Chiasma Inc., Israel; 11Chiasma Inc., USA; 12Chiasma Inc., Israel; 13Allegheny General Hospital, USA; 14Vilnius City University Hospital, Lithuania; 15Kaunas University Clinics, Lithuania; 16Cedars Sinai Medical Center, USA; 17Charité Campus Mitte (Berlin), Germany


Background

Patients with acromegaly may have high symptom burden. The phase 3 MPOWERED trial assessed control of acromegaly by oral octreotide capsules (OOC; MYCAPSSA®) in comparison to injectable somatostatin receptor ligands (iSRLs) in patients responding to both OOC and iSRLs. iSRLs have been first-line medical treatment for patients with acromegaly for decades. OOC are newly approved in the US for patients previously controlled on iSRLs.

Methods

Eligibility criteria for MPOWERED included acromegaly diagnosis, biochemical control of acromegaly (insulin-like growth factor I <1.3 × upper limit of normal; mean integrated growth hormone, <2.5 ng/ml) and ≥6 months’ iSRL (octreotide, lanreotide) treatment. Eligible patients entered a 26-week Run-in phase to determine the effective OOC dose; responders at week 24 then entered a 36-week randomized controlled treatment (RCT) phase receiving OOC or iSRLs. Acromegaly symptom number and severity (mild to severe, 13) were collected. Total score was calculated by summating all severity scores (Acromegaly Index of Severity [AIS]). Symptom results were assessed using total AIS score and proportion of patients experiencing individual symptoms.

Results

At beginning of Run-in, average AIS score of 92 randomized patients was 4.52, representative of symptoms experienced while previously receiving iSRLs. After 26 weeks’ OOC treatment at end of Run-in, average AIS score was significantly reduced to 3.46 (P <0.001). More than 80% of patients on OOC improved or maintained AIS score during Run-in compared to baseline. Over this 26-week period, there was a significant reduction in extremity swelling (P = 0.01) and fatigue (P = 0.03). During the RCT, of patients randomized to OOC (n = 55), 73% maintained or improved AIS score, and 75% maintained or reduced overall number of active symptoms. In comparison, 68% of those randomized to iSRLs (n = 37) maintained or improved AIS score, and 70% maintained or reduced overall number of active symptoms.

Conclusion

Results from MPOWERED show that patients receiving OOC had significant improvement in number and severity of acromegaly symptoms after switching from iSRLs. These findings validate previous results from a phase 3 study of OOC in acromegaly in which patients switching to OOC from iSRLs showed significant reduction in joint pain, extremity swelling, and fatigue.1

Reference

1Melmed S, et al. JCEM. 2015;100(4):16991708.

Volume 73

European Congress of Endocrinology 2021

Online
22 May 2021 - 26 May 2021

European Society of Endocrinology 

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