Pasireotide treatment significantly improves clinical signs and symptoms in patients with Cushing's disease: results from a Phase III study

2014 ◽  
Vol 81 (3) ◽  
pp. 408-417 ◽  
Author(s):  
Rosario Pivonello ◽  
Stephan Petersenn ◽  
John Newell-Price ◽  
James W. Findling ◽  
Feng Gu ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Phase Iii Study ◽  
Clinical Signs And Symptoms

Long-acting pasireotide improves clinical signs and quality of life in Cushing’s disease: results from a phase III study

2020 ◽  
Vol 43 (11) ◽  
pp. 1613-1622 ◽  
Author(s):  
A. Lacroix ◽  
M. D. Bronstein ◽  
J. Schopohl ◽  
T. Delibasi ◽  
R. Salvatori ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cushing’S Disease ◽  
Clinical Signs ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Phase Iii Study ◽  
Long Acting

scholarly journals Treatment effectiveness of pasireotide on health-related quality of life in patients with Cushing's disease

2014 ◽  
Vol 171 (1) ◽  
pp. 89-98 ◽  
Author(s):  
Susan M Webb ◽  
John E Ware ◽  
Anna Forsythe ◽  
Min Yang ◽  
Xavier Badia ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cushing’S Disease ◽  
Treatment Effectiveness ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Cushing's Disease ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

ObjectiveCushing's disease (CD) can significantly impair patients' health-related quality of life (HRQOL). This study investigated the treatment effectiveness of pasireotide on HRQOL of CD patients, and assessed the relationships between HRQOL and urinary free cortisol (UFC) and CD-related signs and symptoms.DesignIn this phase III, randomized, double-blind study, patients with UFC ≥1.5×upper limit of normal (ULN) received s.c. pasireotide 600 or 900 μg twice daily. The trial primary endpoint was UFC at or below ULN at month 6 without dose titration. Open-label treatment continued through month 12. HRQOL was measured using the Cushing's Quality of Life Questionnaire (CushingQoL) instrument at baseline and follow-up visits until month 12 during which clinical signs and features of CD, and the Beck Depression Inventory II (BDI-II), were also collected.MethodsPearson's/Spearman's correlations between changes in CushingQoL and changes in clinical signs and symptoms were assessed. Changes in CushingQoL and the proportion of patients achieving a clinically meaningful improvement in CushingQoL were also compared among patients stratified by mean UFC (mUFC) control status (controlled, partially controlled, and uncontrolled) at month 6. Analyses were also conducted at month 12, with multivariable adjustment for baseline characteristics and CushingQoL.ResultsChange in CushingQoL was significantly correlated with changes in mUFC (r=−0.40), BMI (r=−0.39), weight (r=−0.41), and BDI-II (r=−0.54) at month 12 but not at month 6. The percentage of CushingQoL responders at month 12 based on month 6 mUFC control status were as follows: 63, 58.8, and 37.9% in the controlled, partially controlled, and uncontrolled groups respectively. Adjusted CushingQoL scores at month 12 were 58.3 for controlled patients (Δ=11.5 vs uncontrolled,P=0.012) and 54.5 for partially controlled patients (Δ=7.7 vs uncontrolled,P=0.170).ConclusionsPasireotide treatment can result in a meaningful HRQOL improvement among those who complete a 12-month treatment period, most often among patients achieving biochemical control.

scholarly journals Use of late-night salivary cortisol to monitor response to medical treatment in Cushing’s disease

2020 ◽  
Vol 182 (2) ◽  
pp. 207-217 ◽  
Author(s):  
John Newell-Price ◽  
Rosario Pivonello ◽  
Antoine Tabarin ◽  
Maria Fleseriu ◽  
Przemysław Witek ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Salivary Cortisol ◽  
Clinical Signs ◽  
Urinary Free Cortisol ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Late Night ◽  
Late Night Salivary Cortisol ◽  
Free Cortisol ◽  
Two Samples

Objective Monitoring of patients with Cushing’s disease on cortisol-lowering drugs is usually performed with urinary free cortisol (UFC). Late-night salivary cortisol (LNSC) has an established role in screening for hypercortisolism and can help to detect the loss of cortisol circadian rhythm. Less evidence exists regarding the usefulness of LNSC in monitoring pharmacological response in Cushing’s disease. Design Exploratory analysis evaluating LNSC during a Phase III study of long-acting pasireotide in Cushing’s disease (clinicaltrials.gov: NCT01374906). Methods Mean LNSC (mLNSC) was calculated from two samples, collected on the same days as the first two of three 24-h urine samples (used to calculate mean UFC [mUFC]). Clinical signs of hypercortisolism were evaluated over time. Results At baseline, 137 patients had evaluable mLNSC measurements; 91.2% had mLNSC exceeding the upper limit of normal (ULN; 3.2 nmol/L). Of patients with evaluable assessments at month 12 (n = 92), 17.4% had both mLNSC ≤ULN and mUFC ≤ULN; 22.8% had mLNSC ≤ULN, and 45.7% had mUFC ≤ULN. There was high variability in LNSC (intra-patient coefficient of variation (CV): 49.4%) and UFC (intra-patient CV: 39.2%). mLNSC levels decreased over 12 months of treatment and paralleled changes in mUFC. Moderate correlation was seen between mLNSC and mUFC (Spearman’s correlation: ρ = 0.50 [all time points pooled]). Greater improvements in systolic/diastolic blood pressure and weight were seen in patients with both mLNSC ≤ULN and mUFC ≤ULN. Conclusion mUFC and mLNSC are complementary measurements for monitoring treatment response in Cushing’s disease, with better clinical outcomes seen for patients in whom both mUFC and mLNSC are controlled.

scholarly journals Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study

2016 ◽  
Vol 76 (6) ◽  
pp. 1070-1077 ◽  
Author(s):  
Jürgen Braun ◽  
Xenofon Baraliakos ◽  
Atul Deodhar ◽  
Dominique Baeten ◽  
Joachim Sieper ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Response Rates ◽  
Phase Iii ◽  
X Rays ◽  
Serious Adverse Events ◽  
Radiographic Outcomes ◽  
Clinical Signs And Symptoms ◽  
Radiographic Changes

ObjectiveTo evaluate the effect of secukinumab, an interleukin-17A inhibitor, on clinical signs and symptoms and radiographic changes through 2 years in patients with ankylosing spondylitis (AS).MethodsIn the phase III MEASURE 1 study, patients were randomised to receive intravenous secukinumab 10 mg/kg (at baseline, week 2 and week 4) followed by subcutaneous secukinumab 150 mg (intravenous 150 mg; n=125) or 75 mg (intravenous 75 mg; n=124) every four weeks, or matched placebo (n=122). Placebo-treated patients were re-randomised to subcutaneous secukinumab 150 or 75 mg from week 16. Clinical efficacy assessments included Assessment of SpondyloArthritis international Society 20 (ASAS20) response rates through week 104. Radiographic changes at week 104 were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS).Results97 (77.6%) and 103 (83.1%) patients in the intravenous 150 mg and intravenous 75 mg groups, respectively, completed week 104. In the full analysis set (intent-to-treat), ASAS20 response rates at week 104 were 73.7% and 68.0% in the intravenous 150 mg and intravenous 75 mg groups, respectively. Among patients with evaluable X-rays who were originally randomised to secukinumab (n=168), mean change in mSASSS from baseline to week 104 was 0.30±2.53. Serious adverse events were reported in 12.2% and 13.4% of patients in the 150 mg and 75 mg groups, respectively.ConclusionsSecukinumab improved AS signs and symptoms through 2 years of therapy, with no unexpected safety findings. Data from this study suggest a low mean progression of spinal radiographic changes, which will need to be confirmed in longer-term controlled studies.Trial registration numberNCT01358175.

scholarly journals Monitoring Patient Improvement Parameters following Pasireotide Treatment in Cushing’s Disease

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Chris Yedinak ◽  
Jessica Brzana ◽  
Maria Fleseriu
Keyword(s):  
Cushing’S Disease ◽  
Signs And Symptoms ◽  
Disease Recurrence ◽  
Hormonal Control ◽  
Metabolic Parameters ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Hormone Production ◽  
Improved Outcomes ◽  
The Usa

Cushing’s disease (CD) is a disorder in which chronic excess adrenocorticotropic hormone production is associated with multiple comorbidities and diminished quality of life. Postsurgical monitoring is important, and newer therapies are available for the management of surgical failure or disease recurrence. In this clinical case, we illustrate the importance of the nursing role in long-term management of CD, particularly as nurses may be the first point of contact for patients with CD. Alertness to disease signs and symptoms is crucial for timely diagnosis and improved outcomes. Successful therapy for CD requires careful monitoring of hormonal control, metabolic parameters, and therapy complications. Ongoing management requires lifelong monitoring of metabolic parameters, of side effects of treatment, and of signs of disease recurrence. Appropriate referrals may be required to facilitate overall outcomes and patient wellbeing. This patient was enrolled in a Phase III trial that was registered in the USA with clinicaltrial.gov.

Predictors of response to long-acting pasireotide in patients with Cushing's disease during a Phase III study

2018 ◽  
Author(s):  
Przemyslaw Witek ◽  
Beverly M K Biller ◽  
Andre Lacroix ◽  
Richard Feelders ◽  
Yiming Li ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Predictors Of Response ◽  
Phase Iii Study ◽  
Long Acting

scholarly journals Evaluation of late-night salivary cortisol during a Phase III study with pasireotide in patients with Cushing's disease

2013 ◽  
Author(s):  
John Newell-Price ◽  
Stephan Petersenn ◽  
Rosario Pivonello ◽  
James Findling ◽  
Maria Fleseriu ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Salivary Cortisol ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Late Night ◽  
Late Night Salivary Cortisol ◽  
Phase Iii Study
Sign in / Sign up

Export Citation Format

Share Document