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Article ; Online: A post hoc analysis of Projected Retained Ability Scores (PRAS) for the longitudinal assessment of cognitive functioning in patients with neuronopathic mucopolysaccharidosis II receiving intrathecal idursulfase-IT.

Yee, Karen S / Chirila, Costel / Davenport, Eric / Mladsi, Deirdre / Barnett, Christine / Kronenberger, William G

2023 Volume 18, Issue 1, Page(s) 343

Abstract: Background: Norm-based scores used to assess cognitive ability have clinical value when describing functioning of patients with neuronopathic disorders compared with unaffected, same-age peers. However, they have limitations when used to assess change ... ...

Abstract	Background: Norm-based scores used to assess cognitive ability have clinical value when describing functioning of patients with neuronopathic disorders compared with unaffected, same-age peers. However, they have limitations when used to assess change in cognitive ability between two timepoints, especially in children with severe cognitive decline. Calculation of Projected Retained Ability Scores (PRAS) is a novel method developed to characterize absolute change in norm-based ability test scores. In this analysis, PRAS were calculated post hoc for children with mucopolysaccharidosis II (MPS II; Hunter syndrome) and early cognitive impairment in a 52-week phase 2/3 randomized controlled trial (RCT) and its extension study of intrathecal idursulfase (idursulfase-IT). Patients completing the first year of the extension after receiving idursulfase-IT in the RCT and extension (n = 32 of 34 enrolled) or the extension only (n = 15 of 15 enrolled) were categorized according to changes in Differential Ability Scales, Second Edition, General Conceptual Ability (DAS-II GCA) scores and PRAS at 1 and 2 years. Analyses were conducted in the overall population and a subpopulation aged < 6 years at baseline (idursulfase-IT in the RCT and extension [n = 27] and extension only [n = 12]). Results: PRAS methodology differentiated patients with decreases in DAS-II GCA scores into three separate categories reflecting below-average cognitive growth rates, plateauing cognitive development, and deteriorating cognitive functioning. After 1 year in the RCT, 72.4% of patients who initiated idursulfase-IT had above-average or average cognitive growth rates in DAS-II GCA scores compared with 53.3% of those who did not receive idursulfase-IT; 6.9% versus 20.0% experienced deteriorating cognitive functioning. Similar results were seen in children aged < 6 years: 76% (idursulfase-IT group) versus 50% (no idursulfase-IT) had above-average or average cognitive growth rates in DAS-II GCA scores; 4% versus 17% had deteriorating cognitive functioning. The difference in the distributions of cognitive categories at 1 year in children aged < 6 years was significant (p = 0.048). At 2 years, the proportions of patients in different cognitive categories were more similar between treatment groups. Conclusions: PRAS methodology may help to differentiate changes in cognitive development in MPS II, and therefore may represent a valuable addition to existing approaches for interpreting changes in cognitive scores over time. Trial registration: ClinicalTrials.gov NCT02055118 (registration date: 4 February 2014) and NCT02412787 (registration date: 9 April 2015).
MeSH term(s)	Child ; Humans ; Mucopolysaccharidosis II/drug therapy ; Enzyme Replacement Therapy/methods ; Iduronate Sulfatase/therapeutic use ; Cognition
Chemical Substances	idursulfase (EC 3.1.6.13) ; Iduronate Sulfatase (EC 3.1.6.13)
Language	English
Publishing date	2023-11-02
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article
ZDB-ID	2225857-7
ISSN	1750-1172 ; 1750-1172
ISSN (online)	1750-1172
ISSN	1750-1172
DOI	10.1186/s13023-023-02957-2
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Article ; Online: Understanding Barriers in the Pathway to Diagnosis of Ankylosing Spondylitis: Results From a US Survey of 1690 Physicians From 10 Specialties.

Magrey, Marina / Yi, Esther / Wolin, Daniel / Price, Mark / Chirila, Costel / Davenport, Eric / Park, Yujin

ACR open rheumatology

2020 Volume 2, Issue 10, Page(s) 616–626

Abstract: Objective: Early diagnosis of ankylosing spondylitis (AS) remains challenging because of the high prevalence of chronic back pain in patients initially treated by nonrheumatology health care providers (HCPs). We assessed the patient pathway to ... ...

Abstract	Objective: Early diagnosis of ankylosing spondylitis (AS) remains challenging because of the high prevalence of chronic back pain in patients initially treated by nonrheumatology health care providers (HCPs). We assessed the patient pathway to rheumatology referral, including HCP recognition of inflammatory back pain (IBP) and other features suggestive of AS, diagnostic workup, treatment, and referral to a specialist with the goal of identifying barriers to patient referral to a rheumatologist. Methods: US HCPs from 10 specialties were invited to participate in a cross-sectional web-based survey on clinical characteristics and diagnostic measures leading to IBP suspicion and the subsequent referral process. Eligible HCPs were actively practicing and had referred a patient with suspected IBP or ocular findings (ophthalmology only) within 12 months. Data were analyzed descriptively. Results: Of 1690 HCPs, 61% identified morning stiffness lasting more than 30 minutes, 29% sleep disturbance due to back pain, and 28% pain that improves with activity as features suggestive of IBP. Nearly two-thirds of primary care HCPs reported that they were the first HCPs consulted by patients with suspected IBP. Among HCPs ordering diagnostic blood work, approximately 90% selected antinuclear antibody and rheumatoid factor, whereas 76% selected human leukocyte antigen B27. Almost 40% would treat patients with suspected IBP themselves. HCPs cited lack of adequate specialists nearby (35.1%), insurance restrictions (47.1%), and long wait time (77.0%) as barriers to early referral. Conclusion: Most HCPs had difficulty identifying features suggestive of IBP and indicated insurance restrictions and long wait times as barriers to early referral of patients with potential AS.
Language	English
Publishing date	2020-10-07
Publishing country	United States
Document type	Journal Article
ISSN	2578-5745
ISSN (online)	2578-5745
DOI	10.1002/acr2.11179
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Article ; Online: Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: phase 3 trial results.

Forsythe, Elizabeth / Haws, Robert M / Argente, Jesús / Beales, Philip / Martos-Moreno, Gabriel Á / Dollfus, Hélène / Chirila, Costel / Gnanasakthy, Ari / Buckley, Brieana C / Mallya, Usha G / Clément, Karine / Haqq, Andrea M

Orphanet journal of rare diseases

2023 Volume 18, Issue 1, Page(s) 12

Abstract: Background: Bardet-Biedl syndrome is a rare genetic disease associated with hyperphagia and early-onset, severe obesity. There is limited evidence on how hyperphagia and obesity affect health-related quality of life in patients with Bardet-Biedl ... ...

Abstract	Background: Bardet-Biedl syndrome is a rare genetic disease associated with hyperphagia and early-onset, severe obesity. There is limited evidence on how hyperphagia and obesity affect health-related quality of life in patients with Bardet-Biedl syndrome, and on how management of these symptoms may influence disease burden. This analysis evaluated changes in health-related quality of life in adults and children with Bardet-Biedl syndrome in a Phase 3 trial following 1 year of setmelanotide treatment (ClinicalTrials.gov identifier: NCT03746522). Methods: Patients with Bardet-Biedl syndrome and obesity received 52 weeks of treatment with setmelanotide and completed various self-reported health-related quality of life measures. Patients aged < 18 years or their caregiver completed the Pediatric Quality of Life Inventory (PedsQL; meaningful improvement, 4.4-point change); adults aged ≥ 18 years completed the Impact of Weight on Quality of Life Questionnaire-Lite (IWQOL-Lite; meaningful improvement range, 7.7-12-point change). Descriptive outcomes were reported in patients with data both at active treatment baseline and after 52 weeks of treatment. Results: Twenty patients (< 18 years, n = 9; ≥ 18 years, n = 11) reported health-related quality of life at baseline and 52 weeks. For children and adolescents, PedsQL score mean change from baseline after 52 weeks was + 11.2; all patients with PedsQL impairment at baseline (n = 4) experienced clinically meaningful improvement. In adults, IWQOL-Lite score mean change from baseline was + 12.0. Of adults with IWQOL-Lite impairment at baseline (n = 8), 62.5% experienced clinically meaningful improvement. In adults, IWQOL-Lite score was significantly correlated with changes in percent body weight (P = 0.0037) and body mass index (P = 0.0098). Conclusions: After 1 year of setmelanotide, patients reported clinically meaningful improvements across multiple health-related quality of life measures. This study highlights the need to address the impaired health-related quality of life in Bardet-Biedl syndrome, and supports utility of setmelanotide for reducing this burden. Trial Registration NCT03746522. Registered November 19, 2018, https://clinicaltrials.gov/ct2/show/NCT03746522 .
MeSH term(s)	Adolescent ; Adult ; Humans ; Child ; Quality of Life ; Bardet-Biedl Syndrome ; Obesity ; Hyperphagia
Chemical Substances	setmelanotide
Language	English
Publishing date	2023-01-16
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2225857-7
ISSN	1750-1172 ; 1750-1172
ISSN (online)	1750-1172
ISSN	1750-1172
DOI	10.1186/s13023-022-02602-4
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Article ; Online: Health care resource use analysis of paliperidone palmitate 3 month injection from two phase 3 clinical trials.

Chirila, Costel / Nuamah, Isaac / Woodruff, Kimberly

Current medical research and opinion

2017 Volume 33, Issue 6, Page(s) 1083–1090

Abstract: Objective: The objective of this study was to compare occupational status and health care resource use between treatment groups in clinical trials 3012 (PP3M versus placebo) and 3011 (PP3M versus PP1M).: Methods: Occupational status was assessed at ... ...

Abstract	Objective: The objective of this study was to compare occupational status and health care resource use between treatment groups in clinical trials 3012 (PP3M versus placebo) and 3011 (PP3M versus PP1M). Methods: Occupational status was assessed at each study visit. Logistic regressions modeled the probability of hospitalization during the double-blind phase. Results: At the start of each study, a low percentage of patients were full-time employed or gainfully self-employed (approximately 10% in trial 3012 and 11%-13% in trial 3011). Improvement from baseline in occupational status was slightly higher in the PP3M group than in placebo or PP1M groups. The odds of a hospitalization for psychiatric and social reasons during 1 year was 7.74 (95% CI, 2.39-25.05; p < .001) for a patient on placebo compared with the odds of hospitalization during 1 year for a patient on PP3M. No statistically significant difference was observed between PP3M and PP1M (odds ratio, 1.16; 95% CI, 0.70-1.93). Very similar results were observed for hospitalizations due to psychiatric reasons only, within each trial. Conclusions: In both trials, most patients were unemployed and not seeking work or were retired at open-label baseline, and only a small number of patients changed their occupational status during the trials. In trial 3012, subjects who received placebo had significantly higher odds of hospitalization for either psychiatric and social reasons or for psychiatric reasons alone compared with subjects who received PP3M. In contrast, in trial 3011, the odds of hospitalizations were not significantly different between PP3M and PP1M.
Language	English
Publishing date	2017-06
Publishing country	England
Document type	Journal Article
ZDB-ID	80296-7
ISSN	1473-4877 ; 0300-7995
ISSN (online)	1473-4877
ISSN	0300-7995
DOI	10.1080/03007995.2017.1300144
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Article ; Online: Quality of life outcomes in two phase 3 trials of setmelanotide in patients with obesity due to LEPR or POMC deficiency.

Kühnen, Peter / Wabitsch, Martin / von Schnurbein, Julia / Chirila, Costel / Mallya, Usha G / Callahan, Patrick / Gnanasakthy, Ari / Poitou, Christine / Krabusch, Philipp M / Stewart, Murray / Clément, Karine

Orphanet journal of rare diseases

2022 Volume 17, Issue 1, Page(s) 38

Abstract: Introduction: Individuals with proopiomelanocortin (POMC) or leptin receptor (LEPR) deficiency are young and experience severe obesity, hyperphagia, and comorbidities, which can impair quality of life (QOL).: Methods: Two pivotal Phase 3 trials ... ...

Abstract	Introduction: Individuals with proopiomelanocortin (POMC) or leptin receptor (LEPR) deficiency are young and experience severe obesity, hyperphagia, and comorbidities, which can impair quality of life (QOL). Methods: Two pivotal Phase 3 trials explored the effect of setmelanotide on body weight and hunger in individuals with obesity due to POMC (NCT02896192) or LEPR (NCT03287960) deficiency. QOL and depression were investigated in parallel using the disease-specific, age-appropriate Impact of Weight on Quality of Life-Lite (IWQOL-Lite), Pediatric Quality of Life Inventory (PedsQL), and Patient Health Questionnaire-9 (PHQ-9). Results: In total, the POMC and LEPR trials enrolled 21 patients. Adults (≥ 18 years old; n = 7) had moderate-to-severe impairment in QOL at baseline, with mean (standard deviation [SD]) IWQOL-Lite total score 60.3 (13.2; maximum IWQOL-Lite total score = 100). The effect of setmelanotide on IWQOL-Lite total score was observed as soon as Week 5. Among those with scores at Week 52, 5 of 6 adults experienced a clinically meaningful improvement, with mean (SD) total scores increased from baseline by 24.2 (12.1) points. Children (6-12 years old; n = 2) and adolescents (13-17 years old; n = 4) had impaired QOL at baseline, with mean (SD) self-reported PedsQL total scores 53.3 (6.2) and 63.3 (29.1), respectively (maximum PedsQL total score = 100). Three of 5 patients experienced clinically meaningful improvement in PedsQL, with 2 children whose PedsQL total score increased by 28.3 and 3.3 points and 3 adolescents whose mean (SD) total score increased from baseline by 5.8 (18.3) points. Baseline mean (SD) PHQ-9 score (in those ≥ 12 years old) was 5.3 (3.8) and was generally maintained through Week 52. Conclusions: Patients with POMC or LEPR deficiency had impaired, and in some cases severely impaired, QOL before setmelanotide treatment. Setmelanotide improved QOL in patients as early as Week 5, with some patients no longer experiencing impaired QOL at Week 52. Improvements in QOL may be related to a reduction in hunger and body weight associated with setmelanotide. Because of the highly complex psychological consequences of rare genetic diseases of obesity, some patients may require a long period of treatment to improve QOL and benefit from interdisciplinary care.
MeSH term(s)	Adolescent ; Adult ; Child ; Humans ; Obesity/drug therapy ; Pro-Opiomelanocortin ; Quality of Life ; Receptors, Leptin ; Surveys and Questionnaires ; alpha-MSH/analogs & derivatives
Chemical Substances	Receptors, Leptin ; setmelanotide ; alpha-MSH (581-05-5) ; Pro-Opiomelanocortin (66796-54-1)
Language	English
Publishing date	2022-02-05
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2225857-7
ISSN	1750-1172 ; 1750-1172
ISSN (online)	1750-1172
ISSN	1750-1172
DOI	10.1186/s13023-022-02186-z
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Article: Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures.

Jacquot, Emmanuelle / Collin, Estelle / Ladner, Amy / Tormos, Anita / Hamm, Lynne / Perez-Gutthann, Susana / Gutierrez, Lia / Chirila, Costel / Deltour, Nicolas

Pharmaceutical medicine

2020 Volume 33, Issue 4, Page(s) 311–319

Abstract: Background: Hepatotoxic reactions are an important identified risk listed in the agomelatine risk management plan. This post-authorisation safety study evaluated the effectiveness of additional risk-minimisation measures (aRMMs) for agomelatine.: ... ...

Abstract	Background: Hepatotoxic reactions are an important identified risk listed in the agomelatine risk management plan. This post-authorisation safety study evaluated the effectiveness of additional risk-minimisation measures (aRMMs) for agomelatine. Objective: The objective of this study was to evaluate, among physicians prescribing agomelatine and their patients, liver function monitoring adherence, compliance with contraindications and patients' reasons for non-compliance with liver monitoring. Methods: A non-interventional cohort study was conducted among adults initiating agomelatine in routine clinical practice in Denmark, France, Germany and Spain through a retrospective medical record abstraction (MRA) before and after implementation of aRMMs and a cross-sectional patient survey. Results: Fifty-four sites contributed data on 437 and 404 patients in the before- and after-RMM periods, and 237 patients completed the survey. No patient had cirrhosis in either study period; 98.2% of patients in the before- and 98.0% in the after-RMM period had no active liver disease reported at initiation or during treatment. Compliance to contraindicated medications was > 99% in both periods. The adherence to the liver-monitoring regimen was similar in both periods (15.1% before RMM and 16.3% after RMM). In the after-RMM period, 25.2% of patients had a liver test before or at treatment initiation; 61.5% had a liver test during treatment. Among patients surveyed who did not have a blood test before treatment initiation or during treatment, the most frequently cited reason was a test ordered but not yet performed. Conclusions: The overall adherence to liver-monitoring recommendations remained weakly influenced by aRMMs. However, patients treated with agomelatine are in compliance with relevant contraindications.
MeSH term(s)	Acetamides/adverse effects ; Acetamides/therapeutic use ; Aged ; Chemical and Drug Induced Liver Injury/diagnosis ; Chemical and Drug Induced Liver Injury/prevention & control ; Drug Utilization/statistics & numerical data ; Europe ; Female ; Humans ; Hypnotics and Sedatives/adverse effects ; Hypnotics and Sedatives/therapeutic use ; Liver Function Tests ; Male ; Middle Aged ; Risk Management ; Treatment Outcome
Chemical Substances	Acetamides ; Hypnotics and Sedatives ; agomelatine (137R1N49AD)
Language	English
Publishing date	2020-01-07
Publishing country	New Zealand
Document type	Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2415165-8
ISSN	1179-1993 ; 1178-2595
ISSN (online)	1179-1993
ISSN	1178-2595
DOI	10.1007/s40290-019-00291-2
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Article: A Pilot Study to Assess the Feasibility of a Web-Based Survey to Examine Patient-Reported Symptoms and Satisfaction in Patients with Ankylosing Spondylitis Receiving Secukinumab.

Magrey, Marina / Bozyczko, Michael / Wolin, Daniel / Mordin, Margaret / McLeod, Lori / Davenport, Eric / Chirila, Costel / Park, Yujin

Drugs - real world outcomes

2019 Volume 6, Issue 2, Page(s) 83–91

Abstract: Purpose: This real-world study evaluated the feasibility of assessing patient-reported symptom improvement and treatment satisfaction using a web-based survey among patients with ankylosing spondylitis (AS) treated with secukinumab.: Methods: This ... ...

Abstract	Purpose: This real-world study evaluated the feasibility of assessing patient-reported symptom improvement and treatment satisfaction using a web-based survey among patients with ankylosing spondylitis (AS) treated with secukinumab. Methods: This cross-sectional, web-based survey collected data on demographics, symptoms, treatment history, and treatment satisfaction from US patients with AS who were receiving secukinumab at survey participation. Patients reported AS symptoms experienced before and after secukinumab initiation, time to symptom improvement, and satisfaction with secukinumab treatment. Results: Of 2755 patients screened, 200 with AS were included in the analysis. The mean (SD) age of patients was 34.4 (10.6) years; 86.5% were biologic experienced. Most (74.0%) reported overall improvement ("a little," "moderately," or "much better") in AS symptoms since secukinumab initiation compared with before secukinumab initiation; a similar trend was observed for all the individual symptoms analyzed (pain disrupting sleep, fatigue, morning stiffness, pain and stiffness in lower back or neck, sore areas other than joints, and ankle or heel pain [indicating enthesitis]). Approximately 41.9% of patients reported overall symptom improvement within 4 weeks of secukinumab treatment. Most expressed overall satisfaction ("very," "mostly," or "somewhat satisfied") with secukinumab regarding symptom improvement (99.0%), speed of symptom improvement (97.0%), frequency and method of administration (96.0% and 91.5%, respectively), ease of use (93.5%), patient support services (97.0%), and side effects, if any (93.0%). Conclusion: Most patients reported overall symptom improvement and satisfaction with treatment. Our study indicates that patient-reported perspectives may be feasibly collected using a web-based survey to provide insights into treatment experience and satisfaction.
Language	English
Publishing date	2019-04-23
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2806600-5
ISSN	2198-9788 ; 2199-1154
ISSN (online)	2198-9788
ISSN	2199-1154
DOI	10.1007/s40801-019-0154-4
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Article ; Online: Evaluation of the Feasibility of a Web-Based Survey to Assess Patient-Reported Symptom Improvement and Treatment Satisfaction Among Patients with Psoriatic Arthritis Receiving Secukinumab.

Magrey, Marina / Bozyczko, Michael / Wolin, Daniel / Mordin, Margaret / McLeod, Lori / Davenport, Eric / Chirila, Costel / Hur, Peter

Clinical drug investigation

2019 Volume 39, Issue 12, Page(s) 1205–1212

Abstract: Background and objective: Patient perspectives regarding treatment experience and satisfaction may be useful for clinicians when making treatment strategies. This US-based study assessed the feasibility of evaluating real-world, patient-reported ... ...

Abstract	Background and objective: Patient perspectives regarding treatment experience and satisfaction may be useful for clinicians when making treatment strategies. This US-based study assessed the feasibility of evaluating real-world, patient-reported narratives regarding symptom improvement and treatment satisfaction among patients with psoriatic arthritis treated with secukinumab. Methods: A cross-sectional, web-based survey collected data on demographics, disease characteristics, symptoms before and after secukinumab use, and treatment satisfaction with secukinumab. Results: Of 2755 patients screened, 200 patients with psoriatic arthritis were eligible and included in the analysis. Their mean age was 36.0 (standard deviation, 10.0) years; 55.5% were male and 75.0% were white. Most (87.5%) were biologic experienced; the primary reason for discontinuation of their previous treatment was lack of effectiveness (28.6%). Most patients (79.9%) reported overall psoriatic arthritis symptom improvement after secukinumab initiation compared with before secukinumab initiation; a similar trend was observed for all individual symptoms evaluated. Approximately half of patients reported improvement within 4 weeks after starting secukinumab treatment, and > 90% reported improvement within 6 months. Most patients (≥ 96%) expressed overall satisfaction with secukinumab regarding symptom improvement, speed of symptom improvement, frequency of administration, method of administration, ease of use, patient support services, and side effects, if any. Conclusions: Patient-reported perspectives may be feasibly collected to provide insights into treatment experience and satisfaction of secukinumab. Most patients with psoriatic arthritis in our real-world study experienced symptom improvement after initiating secukinumab; > 50% of patients reported symptom improvement within 4 weeks. Additionally, almost all patients reported satisfaction with secukinumab treatment.
MeSH term(s)	Adult ; Antibodies, Monoclonal, Humanized/therapeutic use ; Arthritis, Psoriatic/drug therapy ; Cross-Sectional Studies ; Feasibility Studies ; Female ; Humans ; Internet ; Male ; Middle Aged ; Patient Reported Outcome Measures ; Patient Satisfaction ; Surveys and Questionnaires
Chemical Substances	Antibodies, Monoclonal, Humanized ; secukinumab (DLG4EML025)
Language	English
Publishing date	2019-09-23
Publishing country	New Zealand
Document type	Evaluation Study ; Journal Article
ZDB-ID	1220136-4
ISSN	1179-1918 ; 0114-2402 ; 1173-2563
ISSN (online)	1179-1918
ISSN	0114-2402 ; 1173-2563
DOI	10.1007/s40261-019-00856-8
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Article ; Online: Treatment satisfaction in type 2 diabetes patients taking empagliflozin compared with patients taking glimepiride.

Chirila, Costel / Zheng, Qingyao / Davenport, Eric / Kaschinski, Dagmar / Pfarr, Egon / Hach, Thomas / Palencia, Roberto

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation

2016 Volume 25, Issue 5, Page(s) 1199–1207

Abstract: Purpose: This exploratory analysis assessed and compared patients' treatment satisfaction with empagliflozin plus metformin versus glimepiride plus metformin, using data obtained from the Diabetes Treatment Satisfaction Questionnaire, status version ( ... ...

Abstract	Purpose: This exploratory analysis assessed and compared patients' treatment satisfaction with empagliflozin plus metformin versus glimepiride plus metformin, using data obtained from the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs) collected in a randomized, double-blind, double-dummy clinical trial. Methods: Observed values for DTSQs scale score and each of its eight items were summarized by visit and treatment arm. Changes from baseline in these scores were analyzed using linear mixed models for repeated measures. Results: The baseline scale score and item scores were comparable between empagliflozin plus metformin (n = 765) and glimepiride plus metformin (n = 780). Compared with baseline, patients reported significant treatment satisfaction increases and significant decreases in perceived hyperglycemia with both treatments at all visits. Also, compared with baseline, a significant increase in perceived frequency of hypoglycemia was observed in the glimepiride treatment group at all visits. No statistically significant treatment difference was observed in DTSQs scale score and its items at week 104. The difference between the treatment groups was significant and in favor of empagliflozin from week 28 onward for perceived frequency of hyperglycemia (P ≤ 0.006) and perceived frequency of hypoglycemia (P ≤ 0.011). Conclusions: Despite positive trends in favor of empagliflozin, there was no significant difference in DTSQs scale score between empagliflozin and glimepiride at 104 weeks. However, when compared with glimepiride, empagliflozin demonstrated significantly lower perceived frequency of hyperglycemia and hypoglycemia at all visits from week 28 onward. This finding is consistent with the clinical results reported for the EMPA-REG H2H-SU trial.
MeSH term(s)	Adult ; Benzhydryl Compounds/adverse effects ; Benzhydryl Compounds/therapeutic use ; Clinical Protocols ; Diabetes Mellitus, Type 2/drug therapy ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Glucosides/adverse effects ; Glucosides/therapeutic use ; Glycated Hemoglobin A/analysis ; Glycated Hemoglobin A/drug effects ; Humans ; Hyperglycemia/chemically induced ; Hypoglycemia/chemically induced ; Hypoglycemic Agents/adverse effects ; Hypoglycemic Agents/therapeutic use ; Male ; Metformin/adverse effects ; Metformin/therapeutic use ; Middle Aged ; Personal Satisfaction ; Quality of Life/psychology ; Sulfonylurea Compounds/adverse effects ; Sulfonylurea Compounds/therapeutic use ; Treatment Outcome
Chemical Substances	Benzhydryl Compounds ; Glucosides ; Glycated Hemoglobin A ; Hypoglycemic Agents ; Sulfonylurea Compounds ; hemoglobin A1c protein, human ; glimepiride (6KY687524K) ; Metformin (9100L32L2N) ; empagliflozin (HDC1R2M35U)
Language	English
Publishing date	2016-05
Publishing country	Netherlands
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1161148-0
ISSN	1573-2649 ; 0962-9343
ISSN (online)	1573-2649
ISSN	0962-9343
DOI	10.1007/s11136-015-1140-2
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Article ; Online: Quality of Life in Adult and Pediatric Patients with Tropomyosin Receptor Kinase Fusion Cancer Receiving Larotrectinib.

Kummar, Shivaani / Berlin, Jordan / Mascarenhas, Leo / van Tilburg, Cornelis M / Geoerger, Birgit / Lassen, Ulrik N / Schilder, Russell J / Turpin, Brian / Nanda, Shivani / Keating, Karen / Childs, Barrett H / Chirila, Costel / Laetsch, Theodore W / Hyman, David M / Drilon, Alexander / Hong, David S

Current problems in cancer

2021 Volume 45, Issue 6, Page(s) 100734

Abstract: Neurotrophic tyrosine receptor kinase (NTRK) gene fusions lead to chimeric tropomyosin receptor kinase (TRK) fusion proteins, which act as primary oncogenic drivers in diverse tumor types in adults and children. Larotrectinib, a highly selective and ... ...

Abstract	Neurotrophic tyrosine receptor kinase (NTRK) gene fusions lead to chimeric tropomyosin receptor kinase (TRK) fusion proteins, which act as primary oncogenic drivers in diverse tumor types in adults and children. Larotrectinib, a highly selective and central nervous system-active TRK inhibitor, has shown high objective response rates, durable disease control, and a favorable safety profile in patients with TRK fusion cancer. The impact of larotrectinib on health-related quality of life (HRQoL) was evaluated in adult and pediatric patients in two phase I/II clinical trials (NAVIGATE; NCT02576431 and SCOUT; NCT02637687). Patients completed HRQoL questionnaires (EORTC QLQ-C30, EQ-5D-5L, and PedsQL) at baseline and at planned treatment cycle visits. Changes in questionnaire scores were evaluated over time, and by tumor type and treatment response. Questionnaires from 40 adult and 17 pediatric (2-19 years of age) patients receiving larotrectinib were completed at baseline and at least one post-baseline timepoint. Meaningful within-patient HRQoL improvements occurred at one or more timepoints in 60% of adults and 76% of pediatric patients. Sustained improvements in EORTC QLQ-C30 and PedsQL scores were rapid, occurring within 2 months of treatment initiation in 68% and 71% of patients, respectively. Improvements were observed regardless of tumor type and appeared to correlate with clinical efficacy. The rapid within-patient HRQoL improvements in adult and pediatric patients with TRK fusion cancer are consistent with the clinical profile of larotrectinib. Our results provide valuable information for use of this agent in this patient population. A plain language summary of this article is available in the supplementary appendix.
MeSH term(s)	Adolescent ; Adult ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Male ; Middle Aged ; Neoplasms/drug therapy ; Neoplasms/genetics ; Neoplasms/psychology ; Protein Kinase Inhibitors ; Protein Kinases/genetics ; Pyrazoles/pharmacology ; Pyrimidines/pharmacology ; Quality of Life/psychology ; Receptor, trkA/genetics ; Surveys and Questionnaires ; Treatment Outcome ; Tropomyosin/genetics ; Young Adult
Chemical Substances	Protein Kinase Inhibitors ; Pyrazoles ; Pyrimidines ; Tropomyosin ; Protein Kinases (EC 2.7.-) ; Receptor, trkA (EC 2.7.10.1) ; tropomyosin kinase (EC 2.7.11.28) ; larotrectinib (PF9462I9HX)
Language	English
Publishing date	2021-04-02
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	441816-5
ISSN	1535-6345 ; 0147-0272
ISSN (online)	1535-6345
ISSN	0147-0272
DOI	10.1016/j.currproblcancer.2021.100734
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