Effectiveness of self- or partner-administration of an extended-release aqueous-gel formulation of lanreotide in lanreotide-naïve patients with acromegaly

Abstract

Surgical resection is often not curative in patients with acromegaly and long-acting somatostatin analogues (lanreotide or octreotide) are often needed. This study assessed the efficacy and safety of self- or partner-administration of lanreotide in patients with acromegaly. This was a six-month, single-arm, open-label study conducted at 13 endocrinology clinics. Fifty-nine patients received deep subcutaneous lanreotide injections every 28 days. Twelve patients started on 120 mg lanreotide and forty-seven started on 90 mg lanreotide. At week 16, the dose was adjusted to 60, 90 or 120 mg based on insulin-like growth factor-1 (IGF-1) levels at week 12. Fifty-nine patients with acromegaly either switched from long-acting octreotide (switch; n = 33) or were somatostatin analogue treatment-naïve or not currently taking long-acting octreotide (“other”; n = 26). The key endpoints included the percentage of patients/partners able to self- or partner-inject lanreotide and those with normal IGF-1 or growth hormone (GH) levels at week 24/early termination. 100% of patients/partners correctly self- (n = 41) or partner-injected (n = 18) lanreotide by week 4. By week 24/early termination, IGF-1 levels were controlled in 93.7% of switch and 46.2% of “other” patients, while GH levels were controlled in 76.9% and 39.1% of patients, respectively. Both IGF-1 and GH were controlled in 73.1% of switch and 30.4% of “other” patients. Most switch patients (81%) reported they preferred lanreotide over long-acting octreotide for future use (P = 0.0001). Self- or partner-administration of lanreotide is generally well tolerated and associated with IGF-1 and GH control in many lanreotide-naïve patients with acromegaly.

Attitudes and preferences in patients with acromegaly on long-term treatment with somatostatin analogues

“…Previous studies of self- or partner administration of SSA in patients with acromegaly report that patients are able and willing to self- or partner inject (12, 13, 14, 15), which is in complete contrast to this study and to the authors’ own clinical experience. The differences in patients’ attitudes might be explained by the patients’ younger age and shorter length of treatment with SSA in the previous studies compared with this study (12, 13, 14, 15).…”

“…Because lanreotide autogel is supplied in prefilled syringes and is injected into deep subcutaneous tissue, it is possible for patients with acromegaly to use self- or partner-administered injection (11), and this offers the possibility to lead a more independent life. Further, injections of lanreotide have been shown to be given reliably and safely outside a health care clinic and are considered as an alternative to injections by health care professionals for motivated patients (12, 13, 14, 15). In the study by Salvatori and coworkers, the primary end-point of which was to evaluate the efficacy and safety of self- or partner administration, 70% of the participants were able to self-inject and 30% to partner inject correctly after training (13).…”

A Consensus Statement on acromegaly therapeutic outcomes

“…Octreotide long-acting release (LAR) is administered once monthly by intramuscular injection; lanreotide autogel is administered once monthly subcutaneously by the patient, their caregiver or a health-care provider. As efficacy rates are similar for the two agents 19,60 , preference for route of delivery and/or associated cost might influence treatment choice 63 (VLQ). Studies have shown that higher doses of octreotide LAR (60 mg every 28 days) as well as higher doses (180 mg every 28 days) and more frequent dosing (120 mg every 21 days) of lanreotide autogel can improve biochemical control rates in patients who are inadequately controlled on standard doses but are responsive to SRL therapy 64,65 (MQ).…”

Expert consensus document: A consensus on the medical treatment of acromegaly

“…This figure is lower than those reported in previous guidelines and published papers that might have had patient selection bias due to the stringent inclusion and exclusion criteria required for clinical trials (MQ). 6,18,24 Long-term (>3 years) results on the efficacy and safety profile of SRLs are reassuring (HQ), 18,25,26 and lowering the SRL dose or decreasing the frequency of administration of SRLs might be considered for patients with long-term control of acromegaly (VLQ). 27 When reducing the SRL dose or decreasing the frequency of administration, patients should be reassessed at regular intervals to ensure maintenance of therapeutic effect (SR).…”

“…18,28 However, lanreotide and octreotide differ in their mode of administration (long-acting lanreotide formulations are available in ready-to-use prefilled syringes that are injected subcutaneously; long-acting octreotide formulations require reconstitution before being injected intramuscularly), which might influence patient convenience (VLQ). 24 At least two other SRL formulations are currently undergoing clinical development for acromegaly: pasireotide, which has a different somatostatin receptor-binding profile; 29 and oral octreotide. 30 …”