Oral octreotide associated with better quality of life, work productivity in acromegaly
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Adults with acromegaly reported improved quality of life and more work productivity after transitioning from injectable somatostatin receptor ligands to oral octreotide capsules, according to MPOWERED phase 3 trial data.
As Healio previously reported, the MPOWERED phase 3 trial met its primary endpoint, with 91% of participants in the oral octreotide (Mycapssa, Chiasma) group maintaining IGF-I response compared with 100% of participants receiving injectable somatostatin receptor ligands. Additional data presented at the American Association of Clinical Endocrinology annual meeting showed oral octreotide was associated with quality of life and work productivity improvements among randomized patients during a 26-week run-in prior to the randomized controlled treatment phase of the trial.
“The improvements seen from the patient’s perspective when transitioning onto oral octreotide should bolster clinicians’ confidence in oral octreotide as a treatment option for patients with acromegaly previously controlled on injectable therapy based on these results, the pivotal Chiasma Optimal trial and data from the MPOWERED trial that showed oral octreotide demonstrated noninferiority relative to injectable SSAs in maintaining IGF-1 response,” Nienke Biermasz, MD, PhD, professor of internal medicine at Leiden University Medical Center in The Netherlands, told Healio.
Biermasz and colleagues recruited 146 people with acromegaly who had previously received injectable somatostatin receptor ligand therapy for at least 4 months in the 26-week run-in portion of the phase 3 trial. Of 146 enrolled participants, 92 were responders and continued to the 36-week randomized controlled treatment phase, where they were randomized to receive either oral octreotide (n = 55) or injectable somatostatin receptor ligands (n = 37). All participants completed the EuroQol-5 Dimensions-5 Levels to measure quality of life, the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem to measure work productivity and the Acromegaly Treatment Satisfaction Questionnaire prior to the start of the run-in period, at the end of the run-in phase and at the end of the randomized controlled treatment phase.
At the end of the run-in phase, randomized trial participants had significant improvements in quality of life score compared with baseline. In the Work Productivity and Activity Impairment Questionnaire, randomized patients reported less presenteeism (least squares mean, –6.65; 95% CI,–12.39 to –0.90; P = 0.024), work productivity loss (least squares mean, –6.92; 95% CI,–12.83 to –1.02; P = 0.022) and activity impairment (least squares mean, –4.94; 95% CI,–9.17 to –0.71; P = 0.022) compared with baseline.
Of the five domains measured in the Acromegaly Treatment Satisfaction Questionnaire, participants had significant improvement in emotional reaction, treatment convenience and treatment satisfaction at the end of run-in compared with baseline. The study was not powered to show statistically significant differences between the oral octreotide and injectable somatostatin receptor ligand groups, and both groups had similar results in quality of life and work productivity scores during the randomized controlled treatment phase of the trial. However, the oral octreotide group reported significantly better treatment satisfaction scores compared with the injectable somatostatin receptor ligand cohort (P < .04).
“The benefit-risk profile of oral octreotide has been overwhelmingly consistent across three phase 3 studies, so real-world evidence is the next logical step for which the MACRO registry that is currently capturing the experience of people with acromegaly would potentially provide further valuable insights on both disease burden and effectiveness of various treatments,” Biermasz said.
Perspective
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Adriana G. Ioachimescu, MD, PhD, FACE
Acromegaly is a chronic disease with a high burden of psychosocial problems, even in biochemically controlled patients. Medical therapy with somatostatin receptor ligands can be administered as injections or oral octreotide capsules, the latter approved by the FDA in 2020 for patients who responded to injectable octreotide or lanreotide. Patient-reported outcomes have been incorporated in the design of recent acromegaly clinical trials.
In her presentation, Dr. Biermasz reported quality of life, work productivity and activity impairment scores. Patients in biochemical control on injectable somatostatin receptor ligands were randomized to either to oral octreotide (n = 55) or injectable somatostatin receptor ligand continuation (n = 37). As expected, baseline scores were similar between the two groups. In the oral octreotide group, mean scores improved after 26 weeks of treatment. Since each patient served as their own control, the change likely reflects transitioning from injectable somatostatin receptor ligands to oral octreotide. The study was not powered to demonstrate inter-group differences — oral octreotide vs. injectable somatostatin receptor ligands — at the end of the randomized-controlled phase; however, treatment satisfaction scores were higher for oral octreotide.
The results highlight the importance of incorporating the patient’s perspective in clinical practice and providing psychological and social support when needed. Further studies are necessary to correlate biochemical and radiological parameters with the patient-reported outcomes, assess quality of life longitudinally for longer time periods, and compare patient and clinician perception regarding disease control.
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Biermasz N. Improved quality of life and work productivity in patients with acromegaly receiving oral octreotide capsules in the phase 3 MPOWERED trial. Presented at: American Association of Clinical Endocrinology Annual Meeting; May 26-29, 2021 (virtual meeting).
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