AACE 25th Annual Scientific & Clinical Congress:

Acromegaly Questionnaire (Acro-TSQ) in Development to Assess Treatment Satisfaction Among Patients

EndocrineWeb spoke with Murray B. Gordon, MD regarding his research group’s study to develop a patient-reported assessment tool for clinician use in the treatment of patients with acromegaly. Dr. Gordon is the Interim Division Director, Endocrinology at West Penn Allegheny Health System, in Allegheny, PA. The poster was presented during the American Association of Clinical Endocrinologists (AACE) 25th Annual Scientific & Clinical Congress held in Orlando, FL.

About Acromegaly, Study Objective
Acromegaly is a rare and chronic disease caused by hypersecretion of growth hormone (GH). In the Endocrine Society’s Acromegaly Clinical Practice Guideline, this abnormal over-secretion of GH leads to a “multisystem disease” characterized by somatic multiple comorbidities, premature mortality, and potential for physical disfigurement.1 Acromegaly is a complex disease requiring a multidisciplinary treatment approach. “The objective of the study is to develop a tool for clinicians to assess patient perspectives on their treatment burden and acromegaly symptoms,” stated Dr. Murray.
growth hormone written on notebook.“While an oral SSA [somatostatin analogue] formulation is in development, there are no available patient-reported outcome (PRO) instruments that assess the burden of and satisfaction with different routes of drug administration (eg, injection vs. oral),” as the authors stated in their poster.2 The poster represented a pilot study of 19 patients with acromegaly.

Methods and Outcomes
Acromegaly patient enrollment criteria included residents of the United States (US), ages 18 to 75 years, who were receiving an injectable somatostatin (ie, long-activing ianreotide or long-acting octreotide) at a stable dose for 6 months or longer. Participants were interviewed about aspects of their treatment, including treatment effectiveness, administration of medication via injection, breakthrough symptoms, side effects, and overall satisfaction. The interview questions were extensive, and not all patients were asked the same questions.

From the interview (n=19) and more recently, validation study (n=79) the questionnaire, called the Acro-TSQ (treatment satisfaction questionnaire) was drafted. The validation study included patients across the US and Europe. The results of that study have not been fully analyzed yet, although findings are expected soon. “We call it the Acro-TSQ with the idea in mind that an oral therapy is being developed; in fact, it is in Phase III trials. The purpose of the questionnaire is to compare how patients feel about their treatment administration—oral vs injection and breakthrough symptoms,” said Dr. Murray.

Concluding Comments
“These patients [pilot study, n=19] were biochemically controlled, but what surprised me was the frequency of breakthrough symptoms, which were quite high.  Eighty-four percent (84%) of patients experienced breakthrough symptoms,” explained Dr. Murray. Furthermore, at the end of the treatment interval of about 28 days, a large number of patients reported symptoms of joint pain, fatigue, and headache. Smaller numbers of participants reported swelling in the hands/feet and joint stiffness.

Dr. Murray concluded by stating, “The question would be, when we finish and validate the questionnaire with the oral treatment, if given daily, would it be sufficient to prevent these breakthrough symptoms?”

 

References
1  Katznelson L, Laws Jr ER, Melmed S, Molitch ME, et al. Acromegaly: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2014;99(11):3933-3951.

2  Fleseriu M, Fogelfeld L, Gordon MB, Sisco J, et al. A study to develop a novel patient-reported outcome (PRO) instrument to assess satisfaction with acromegaly treatment: the Acro-TSQ. Poster 1304. American Association of Clinical Endocrinologists (AACE) 25th Annual Scientific & Clinical Congress. Orlando, FL. May 25-29, 2016.

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