Treatment adherence to pegvisomant in patients with acromegaly in Spain: PEGASO study

Cámara, Rosa; Venegas, Eva; García-Arnés, Juan Antonio; Cordido, Fernando; Aller, Javier; Samaniego, Millie; Mir, Nuria; Sánchez‐Cenizo, Laura

doi:10.1007/s11102-019-00943-1

Cited by 10 publications

(9 citation statements)

References 28 publications

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“…Herein, we show the first real world data evaluating disease activity status using ACRODAT ® and its correlation with physicians' criteria, in a representative cohort of 111 Spanish patients attended in a clinical practice setting. Patient population was similar to other studies [27,28], with a mean age of 59.7 years and 51.4% of women. 60.7% of patients were controlled in terms of IGF-I and tumour volume.…”

Section: Discussionsupporting

confidence: 75%

Acromegaly disease activity according to ACRODAT®, a cross-sectional study in Spain: ACROVAL study

et al. 2021

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Objectives To evaluate disease activity status using the Acromegaly Disease Activity Tool (ACRODAT®) in a cohort of Spanish acromegaly patients, to assess the relationship between the level of disease activity according to both ACRODAT® and the physicians’ clinical evaluation, and to study the potential discrepancies in the perception of symptoms between physicians and patients. Design Multicenter, observational, descriptive and cross-sectional study. Methods Disease activity was assessed in adult patients with acromegaly under pharmacological treatment during at least 6 months using ACRODAT®. Results According to ACRODAT®, 48.2%, 31.8% and 20.0% of a total of 111 patients were classified as having a stable disease (S), mild disease activity (M-DA) and significant disease activity (S-DA) respectively. ACRODAT® classification of disease activity significantly correlated with physicians’ opinion, with a moderate inter-rater agreement and a specificity of 92.45% (PPV = 86.21%). No correlation was found between IGF-I levels and severity of symptoms or quality of life (QoL). A decision to take clinical action was significantly more frequent in S-DA and M-DA patients than S patients but no action was taken on 5 (22.7%) and 27 (77.1%) S-DA and M-DA patients, respectively Conclusions ACRODAT® detected disease activity in 51.8% of patients. Interestingly, although M-DA and S-DA patients were likely to be in the process of being controlled, action was not always taken on these patients. ACRODAT® is a validated and highly specific tool that may be useful to routinely monitor acromegaly and to identify patients with non-obvious disease activity by incorporating “patient-centred” parameters like symptoms and QoL to the clinical evaluation of acromegaly.

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Section: Discussionsupporting

confidence: 75%

Acromegaly disease activity according to ACRODAT®, a cross-sectional study in Spain: ACROVAL study

et al. 2021

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“…No study assessing pegvisomant monotherapy reported AEs and no study examining pegvisomant at EDIs either as mono- or combination therapy reported on treatment-related deaths. Treatment adherence was higher at standard intervals compared with EDIs (n = 1 study), measured with the patient-reported Haynes-Sackett questionnaire, but it was unclear whether patients received pegvisomant combination therapy or monotherapy at the time the questionnaire was administered (Table 2 ) [ 39 ]. One patient-reported reason for lack of adherence to EDIs of pegvisomant was forgetfulness due to non-daily administration [ 39 ].…”

Section: Resultsmentioning

confidence: 99%

A systematic literature review to evaluate extended dosing intervals in the pharmacological management of acromegaly

et al. 2022

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Purpose This systematic literature review investigated whether extended dosing intervals (EDIs) of pharmacological acromegaly treatments reduce patient burden and costs compared with standard dosing, while maintaining effectiveness. Methods MEDLINE/Embase/the Cochrane Library (2001–June 2021) and key congresses (2018–2021) were searched and identified systematic literature review bibliographies reviewed. Included publications reported on efficacy/effectiveness, safety and tolerability, health-related quality of life (HRQoL), and patient-reported and economic outcomes in longitudinal/cross-sectional studies in adults with acromegaly. Interventions included EDIs of pegvisomant, cabergoline, and somatostatin receptor ligands (SRLs): lanreotide autogel/depot (LAN), octreotide long-acting release (OCT), pasireotide long-acting release (PAS), and oral octreotide; no comparator was required. Results In total, 35 publications reported on 27 studies: 3 pegvisomant monotherapy, 11 pegvisomant combination therapy with SRLs, 9 LAN, and 4 OCT; no studies reported on cabergoline, PAS, or oral octreotide at EDIs. Maintenance of normal insulin-like growth factor I (IGF-I) was observed in ≥ 70% of patients with LAN (1 study), OCT (1 study), and pegvisomant monotherapy (1 study). Achievement of normal IGF-I was observed in ≥ 70% of patients with LAN (3 studies) and pegvisomant in combination with SRLs (4 studies). Safety profiles were similar across EDI and standard regimens. Patients preferred and were satisfied with EDIs. HRQoL was maintained and cost savings were provided with EDIs versus standard regimens. Conclusions Clinical efficacy/effectiveness, safety, and HRQoL outcomes in adults with acromegaly were similar and costs lower with EDIs versus standard regimens. Physicians may consider acromegaly treatment at EDIs, especially for patients with good disease control.

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“…This study reveals that the principal obstacle was the transportation of the pegvisomant (especially maintaining the cold chain during transportation) and anxiety about the injection. One third of patients made mistakes during the reconstitution (17%) and administration (22%) of pegvisomant [17].…”

Section: Adherencementioning

confidence: 99%

Pegvisomant in Acromegaly and Gigantism

Briet¹,

Suteau²,

Rodien³

2020

Growth Disorders and Acromegaly

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Pegvisomant is a GH antagonist used in acromegaly in gigantism. Pegvisomant is a modified GH molecule with pegylation to increase half-life and nine amino acid substitutions to modify GH receptor affinity and dimerization. Pegvisomant leads to an IGF1 decrease. It is administered subcutaneously every day with a median dose of 15 mg/ day in meta-analysis. This treatment is indicated in acromegaly or gigantism in case of resistance to somatostatin analogs. This drug leads to a control of acromegaly in 90% of patients in phase III study and about 70% of patients in real-life study. In gigantism, only 50% of children are controlled with pegvisomant. It is a well-tolerated treatment with hepatic side effects in 3% of cases, headache in 2% of cases, and lipohypertrophy in 3% of cases. Pegvisomant does not act on adenoma size, and 6% of increasing tumour size is observed. Indeed, pegvisomant is an antagonist of GH receptor with a good efficacy which can be used alone or in association with somatostatin analog or cabergoline if acromegaly is not controlled by a somatostatin analog.

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Treatment adherence to pegvisomant in patients with acromegaly in Spain: PEGASO study

Cited by 10 publications

References 28 publications

Acromegaly disease activity according to ACRODAT®, a cross-sectional study in Spain: ACROVAL study

Acromegaly disease activity according to ACRODAT®, a cross-sectional study in Spain: ACROVAL study

A systematic literature review to evaluate extended dosing intervals in the pharmacological management of acromegaly

Pegvisomant in Acromegaly and Gigantism

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