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Endocrine Abstracts (2021) 73 PEP13.6 | DOI: 10.1530/endoabs.73.PEP13.6


1Allegheny General Hospital, USA; 2Oregon Health & 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; 10Ohio State University, USA; 11APHP - Hôpital Bicêtre, France; 12Chiasma, Inc., Israel; 13Chiasma, Inc., USA; 14Leiden University Medical Center, Netherlands; 15Cedars Sinai Medical Center, USA; 16Charite Campus Mitte, Germany


Background

Improved patient-reported outcomes (PROs) are increasingly becoming a key treatment objective in acromegaly. Validated PROs were used to assess disease and treatment burden in the MPOWERED phase 3 trial in acromegaly, which also assessed safety and efficacy of oral octreotide capsules (OOC; MYCAPSSA®) compared to injectable SRLs (iSRLs).

Methods

Eligible patients had 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 treatment (octreotide or lanreotide). 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 in a 3:2 ratio. The Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) is a recently validated tool that includes 27 items in 6 domain scores for PROs in acromegaly.1 Acro-TSQ data were collected at baseline (reflecting outcomes on iSRLs), end of Run-in (reflecting outcomes on OOC), and end of RCT (OOC or iSRLs).

Results

Of 146 enrolled patients, 92 entered RCT (OOC, N = 55; iSRLs, N = 37). Acro-TSQ scores at the end of Run-in (26 weeks’ OOC treatment) were compared to baseline (iSRLs). In the 92 patients randomized, 3 of 5 Acro-TSQ domains (emotional reaction, treatment convenience, and treatment satisfaction) showed significant improvement at end of Run-in compared to baseline. Injection site interference was not assessed as no injection site reactions were observed with OOC. Other domains showed a nonstatistically significant pattern of improvement at end of Run-in when compared to baseline. Patients randomized to iSRLs in the RCT after receiving OOC in the Run-in (N = 37) reported more anxiety (RCT end, 53%; Run-in end, 29%) and frustration (RCT end, 45%; Run-in end, 34%) with iSRLs compared to OOC. Overall treatment satisfaction was higher while receiving OOC (Run-in end, 92%; after receiving iSRLs in RCT, 75%). Breakthrough symptoms were reported more frequently with iSRLs (31%) than OOC (15%) at the end of RCT.

Conclusion

Higher patient satisfaction, convenience and emotional well-being, and improved symptom control based on the newly validated Acro-TSQ PRO reporting tool were observed with OOC compared to iSRLs in patients enrolled in the MPOWERED trial.

Reference

1Fleseriu M, et al. Pituitary. 2020 Aug;23(4):347–358.

Volume 73

European Congress of Endocrinology 2021

Online
22 May 2021 - 26 May 2021

European Society of Endocrinology 

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