ECE2020 Audio ePoster Presentations Pituitary and Neuroendocrinology (217 abstracts)
Biochemical control of most patients reverting to injectable long-acting somatostatin receptor ligands is achieved after one dose: Results from the phase 3, randomized, double blind, placebo-controlled optimal study
Maria Fleseriu 1 , Susan Samson 2 , Lisa Nachtigall 3 , Artak Labadzhyan 4 , Atanaska Elenkova 5 , Mark E Molitch 6 , William Ludlam 7 , Gary Patou 7 , Asi Haviv 7 , Nienke Biermasz 8 , Christian J Strasburger 9 , Laurence Kennedy 10 & Shlomo Melmed 4
1Oregon Health & Science University, United States; 2Baylor College of Medicine, United States; 3MGH Neuroendocrine and Pituitary Center, United States; 4Cedars Sinai Medical Center, United States; 5Medical University Sofia, Bulgaria; 6Northwestern University, United States; 7Chiasma, United States; 8Leiden University Medical Center, Netherlands; 9Charité Campus Mitte, Germany; 10Cleveland Clinic Foundation, United States
Background: Injectable somatostatin receptor ligands (SRLs) are currently the most widely used therapy for acromegaly. Oral octreotide capsules (OOC) are a potential therapy for acromegaly; the safety and efficacy were evaluated in the CHIASMA OPTIMAL pivotal study (Samson et al. ENDO 2020). As reported, mean IGF-I levels of the OOC group were maintained within normal range at end of treatment in all patients. However, some patients may not respond to OOC treatment (25% of OOC and 68% of placebo required rescue, P = 0.003). This analysis describes the degree and rapidity with which patients achieve biochemical control (IGF–I ≤ 1.0 × ULN) when reverted to their prior injectable SRL.
Methods: Patients with confirmed acromegaly and receiving a stable dose of injectable SRL (≥ 3 months) were randomized to OOC (40 mg/day; n = 28) or placebo (n = 28) for 36 weeks. Patients were dose titrated to 60 or 80 mg of OOC (or placebo) through week 24 at investigator discretion based on increased IGF-I levels and/or worsening acromegaly signs/symptoms. Patients could be rescued via prior injectable SRL therapy if they met predefined withdrawal criteria (IGF–I ≥ 1.3 × ULN; 2 consecutive visits on the highest doseand exacerbation of clinical signs/symptoms) or discontinued treatment for any reason. Seven patients in the OOC and 19 in the placebo group required rescue. The change in IGF-I from Baseline was compared to the end of the Double-blind Placebo Controlled period.
Results: In patients rescued up to week 32 (with ≥4 weeks of follow-up), baseline IGF-I levels(mean; Screening Visit 2 and Baseline) were 0.80 and 0.87 × ULN in OOC and placebo groups,respectively. In patients receiving rescue therapy, the end of study IGF-I levels (mean; week 34 and 36) were 0.80 and 0.89 × ULN in OOC and placebo groups, respectively. The median time to return to normal IGF-I values following loss of response was 4.0 weeks after discontinuing either OOC or placebo. Therefore, most patientswho required rescue following a short trial of OOC returned to their baseline values following a single SRL injection.
Conclusion: Most treatment failures in the CHIASMA OPTIMAL trial(either OOC or placebo) rescued with injectable SRL re-established their baseline response levels after a single injectable SRL administration (at pre-study dose). Based on these data, patients may potentially be treated with OOC and for those not responding, either not biochemically-controlled or who have adverse effects, they may be able to return to injectable SRLs with immediate IGF-I control after one SRL injection.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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