Evaluation of Acromegaly Symptoms from the Newly Developed Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ): A Prospective Patient-Reported Outcome Study
Presentation Number: SUN 448
Date of Presentation: April 2nd, 2017
Maria Fleseriu*1, Leon Fogelfeld2, Murray B. Gordon3, Jill Sisco4, William Henry Ludlam5, Asi Haviv6 and Susan D Mathias7
1Oregon Hlth and Sci Univ, Portland, OR, 2John H. Stroger, Jr. Hospital of Cook County, Chicago, IL, 3Allegheny General Hospital, Pittsburgh, PA, 4Acromegaly Community, Grove, OK, 5Chiasma, Inc., Waltham, MA, 6Chiasma, Jerusalem, Israel, 7Health Outcomes Solutions, Winter Park, FL
Background The Acro-TSQ is a novel tool, assessing acromegaly-specific patient-reported outcomes (PRO) related to medical treatment, including mode of administration. Six items focus on acromegaly symptoms including symptom bother and interference. Results from these symptom items using data from a recent validation study were examined to more fully understand the unmet needs of patients with acromegaly.
Methods 79 patients with acromegaly on a stable dose of SRL injections (lanreotide and octreotide LAR) for > 6 months from 14 sites in the US, UK and the Netherlands were enrolled and completed the Acro-TSQ and other PRO tools at enrollment (Baseline), Day 7, and Month 3, following IRB approval. Descriptive analyses at the item and scale level were conducted.
Results Item-level results indicated that 61% (48/79) of patients reported acromegaly symptoms at baseline. Thirty-nine patients (81% of those reporting symptoms), experience symptoms all the time; 41 patients (85%) report some degree of bother by these symptoms. Patients who reported symptoms also report that symptoms interfere with daily activities (90%), with leisure activities (82%) and with work (68% of those who work), while an additional 12 patients (25%) do not work because of acromegaly. When examining scale-level results at baseline, the Acromegaly Symptom scale displayed acceptable internal consistency reliability (Cronbach’s alpha coefficient = 0.711) and high test-retest reliability (intra-class correlation coefficient = 0.957). Correlations of the Acro-TSQ Symptom scale were highest with the Physical scale of the Acro-QoL (0.579; p < 0.01). Significant differences (p<0.001) were found for the Acro-TSQ Symptom scale when categorized by patient’s global assessment of symptom severity (PGA) scores, with lower scores representing more symptom interference (absent/mild: 73 + 20, moderate: 58 + 17, severe/very severe: 33 + 18).
Conclusions Patients with acromegaly continue to experience symptoms despite receiving SRL injections. The Acro-TSQ is currently being used in the Mpowered phase 3 study, assessing octreotide capsules vs. injectable SRLs in patients with acromegaly. This tool can be used by clinicians to monitor patients’ satisfaction with various modes of administration for acromegaly treatments and, in addition, can specifically allow clinicians to track the extent to which symptoms may be alleviated with efficacious treatment.
Disclosure: MF: Principal Investigator, Novartis Pharmaceuticals, Ad Hoc Consultant, Novartis Pharmaceuticals, Principal Investigator, Chiasma, Ad Hoc Consultant, Chiasma, Principal Investigator, Pfizer Global R&D, Ad Hoc Consultant, Pfizer Global R&D. MBG: Principal Investigator, Novartis Pharmaceuticals, Principal Investigator, Corcept. WHL: Vice President, Chiasma, Inc. AH: Vice President, Chiasma, Inc. Nothing to Disclose: LF, JS, SDM