Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study

Philippe J Caron, John S Bevan, Stephan Petersenn, Aude Houchard, Caroline Sert, Susan M Webb, PRIMARYS Investigators Group, L Van Gaal, J Marek, P Nuutila, M Välimäki, C Ajzenberg, F Borson-Chazot, T Brue, P Caron, O Chabre, P Chanson, C Cortet Rudelli, B Delemer, J -M Kuhn, A Tabarin, K Badenhoop, C Berg, S Petersenn, C Schöfl, J Schopohl, S Cannavò, A Colao, L De Marinis, A Stades, A J van der Lely, Turkey P Kadıoğlu, J S Bevan, D Flanagan, P Trainer, Philippe J Caron, John S Bevan, Stephan Petersenn, Aude Houchard, Caroline Sert, Susan M Webb, PRIMARYS Investigators Group, L Van Gaal, J Marek, P Nuutila, M Välimäki, C Ajzenberg, F Borson-Chazot, T Brue, P Caron, O Chabre, P Chanson, C Cortet Rudelli, B Delemer, J -M Kuhn, A Tabarin, K Badenhoop, C Berg, S Petersenn, C Schöfl, J Schopohl, S Cannavò, A Colao, L De Marinis, A Stades, A J van der Lely, Turkey P Kadıoğlu, J S Bevan, D Flanagan, P Trainer

Abstract

Purpose: To evaluate the effects of lanreotide Autogel on patient-reported outcomes and association with biochemical control, using PRIMARYS data.

Methods: PRIMARYS was a 1-year, open-label study of lanreotide Autogel (Depot in USA) 120 mg every 4 weeks in 90 treatment-naïve patients with acromegaly. Symptoms were assessed using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) and health-related quality of life (HRQoL) using the AcroQoL questionnaire. Correlations between PASQ and AcroQoL scores, and between PASQ/AcroQoL and growth hormone (GH)/insulin-like growth factor-1 (IGF-1) levels were also evaluated (post hoc).

Results: Acromegaly symptoms and HRQoL significantly improved from week 12 to week 48, with modest correlations at week 48 between PASQ total score (R = -0.55, p < 0.0001) and AcroQoL global and physical scores (R = -0.67, p < 0.0001). Approximately 60% of patients achieved a minimal important difference (MID; improvement >50% of baseline standard deviation) in PASQ total score and >40% achieved a MID in AcroQoL global score (post hoc). Changes in PASQ scores were similar in biochemically controlled (GH levels ≤2.5 μg/L and normal IGF-1 levels) and uncontrolled groups, while changes in global and psychological AcroQoL scores were greater in the controlled group. There was no correlation between changes in PASQ or AcroQoL scores and changes in GH or IGF-1 levels.

Conclusions: Primary treatment with lanreotide Autogel over 1 year was associated with rapid and sustained improvements in clinical signs and symptoms and HRQoL in patients with acromegaly. Improvements in HRQoL, but not symptoms, were greater in those achieving biochemical control (ClinicalTrials.gov: NCT00690898; EudraCT: 2007-000155-34).

Keywords: Acromegaly; Lanreotide Autogel; Quality of life; Symptoms.

Figures

Fig. 1
Fig. 1
Mean (95 % CI) change in PASQ scores during treatment with Lanreotide Autogel. Each symptom is assessed on a 9-point scale, total maximum score = 40 (higher scores indicate worse symptoms); baseline scores are summarized in Table 1. Full data for this Figure are provided in Supplementary Table S2. CI confidence interval, PASQ patient-assessed acromegaly symptom questionnaire
Fig. 2
Fig. 2
Mean (95 % CI) change in AcroQoL scores during treatment with Lanreotide Autogel. Scores for each dimension/sub-dimension are standardized from 0 to 100 (higher scores = better HRQoL); baseline scores are summarized in Table 1. Full data for this Figure are provided in Supplementary Table S2. CI confidence interval, AcroQoL acromegaly quality of life questionnaire
Fig. 3
Fig. 3
Changes in AcroQoL scores for patients with and without biochemical control during treatment with Lanreotide Autogel. AcroQoL acromegaly quality of life questionnaire, CI confidence interval. Asterisks indicate non-overlapping CIs, i.e. statistically significant between-group differences. Baseline scores are summarized in Table 1

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