Disease and Treatment-Related Burden in Patients With Acromegaly Who Are Biochemically Controlled on Injectable Somatostatin Receptor Ligands

Abstract

Medical treatment for acromegaly commonly involves receiving intramuscular or deep subcutaneous injections of somatostatin receptor ligands (SRLs) in most patients. In addition to side effects of treatment, acromegaly patients often still experience disease symptoms even when therapy is successful in controlling GH and IGF-1 levels. Symptoms and side effects can negatively impact patients’ health-related quality of life. In this study, we examine the disease- and treatment-related burden associated with SRL injections as reported through the use of the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ ©) and clinician-reported symptom severity through the Acromegaly Index of Severity (AIS). Patients included in this analysis were enrolled in a randomized phase 3 study, were biochemically-controlled (an IGF-1 < 1.3 × the upper limit of normal [ULN] and average GH < 2.5 ng/ml) and receiving SRL injections for ≥6 months with a stable dose of either long-acting octreotide or lanreotide monotherapy for ≥4 months. The sample (N = 91) was 65% female, 91% Caucasian, with a mean [standard deviation (SD)] age of 53 (1) years. Two-thirds of patients reported that they still experience acromegaly symptoms; 82% of these said they experience symptoms all of the time. Three-fourths experienced gastrointestinal (GI) side effects after injections, and 77% experienced treatment-related injection site reactions (ISRs). Patients commonly reported that these interfered with their daily life, leisure, and work activities. Those with higher symptom severity, as measured by the AIS, scored significantly worse on several Acro-TSQ domains: Symptom Interference, GI Interference, Treatment Satisfaction, and Emotional Reaction. Despite being biochemically controlled with injectable SRLs, most patients reported experiencing acromegaly symptoms that interfere with daily life, leisure, and work. GI side effects and ISRs were also common. This study highlights the significant disease burden that still persists for patients with acromegaly that have achieved biochemical control with the use of injectable SRLs.

Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results

“…The Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) is a scale that was developed to provide a complete assessment of the disease and treatment burdens associated with acromegaly and for tracking the overall efficacy and unmet needs of new treatments for patients with acromegaly [ 9 , 14 ]. In 1 analysis employing the Acro-TSQ, two-thirds of patients who were biochemically responding to iSRLs reported ongoing acromegaly symptoms, with > 80% experiencing those symptoms all the time [ 15 ]. Avoiding injections, potentially by substituting an oral formulation, was mentioned as a top preference for new acromegaly treatments among 85% of respondents [ 13 ].…”

The Effect of Aging on Quality of Life in Acromegaly Patients Under Treatment

“…In the present study, 31 (79%) of 39 patients receiving medical therapy used somatostatin analogs; however, there was no significant difference in the proportion of patients using somatostatin analogs between the younger and older groups. It has been reported that treatment-related burdens such as gastrointestinal side effects, injection site reactions, and the need for periodic drug injections interfere with their daily and work activities, even for the biochemically controlled status of somatostatin analogs ( 25 ). The treatment-related burden can lead to QoL impairment for younger patients because of their social status.…”

Clinical Management of Acromegaly: Therapeutic Frontiers and New Perspectives for Somatostatin Receptor Ligands (SRLs)

“…Despite an overall improved QoL thanks to disease control, patients treated with FG-SRLs still experience reduced QoL because of therapy-related burden [14]. A recent study has shown that around three out of four patients experience gastro-intestinal side effects and/or local site reactions after SRLs injection, impacting on the daily life of more than half of the cases [15]. Therefore, with the purpose of avoiding discomfort of parenteral administration and improving both patients' QoL and therapeutic adherence, new formulations of FG-SRLs have recently been developed.…”