scholarly journals TO002REDUCTION IN THE RATE OF EGFR DECLINE WITH SEMAGLUTIDE VS PLACEBO: A POST HOC POOLED ANALYSIS OF SUSTAIN 6 AND PIONEER 6

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Katherine Tuttle ◽  
David Cherney ◽  
Samy Hadjadj ◽  
Thomas Idorn ◽  
Ofri Mosenzon ◽  
...  
Keyword(s):  
Kidney Function ◽  
Pooled Analysis ◽  
Random Regression ◽  
Once Daily ◽  
Beneficial Effects ◽  
Pooled Data ◽  
Random Regression Model ◽  
Post Hoc ◽  
Egfr Slope

Abstract Background and Aims The SUSTAIN 6 cardiovascular outcomes trial (CVOT) indicated that once-weekly (OW) subcutaneous (s.c.) semaglutide may have beneficial effects on kidney function. SUSTAIN 6 and the more recent PIONEER 6 CVOT (oral semaglutide) had similar designs and subject populations; both evaluated the effects of semaglutide compared with placebo on important macro- and microvascular outcomes. This post hoc analysis of pooled data from the two trials evaluated the effects of semaglutide vs placebo on kidney function, assessed by estimated glomerular filtration rate (eGFR) slope. Method Data for 6,480 subjects from SUSTAIN 6 (OW s.c. semaglutide 0.5 and 1.0 mg or placebo, n=3,297; median follow-up 2.1 years) and PIONEER 6 (oral semaglutide once-daily 14 mg or placebo, n=3,183; median follow-up 1.3 years) were pooled into two groups: semaglutide and placebo. Annual change in eGFR was compared between semaglutide and placebo in patients with eGFR data at baseline, both overall and by baseline eGFR subgroup (≥30–<60 or ≥60 mL/min/1.73 m2). Data were analysed using a linear random regression model with individual intercept and time slope. Estimated treatment difference (ETD) between annual rates of eGFR slope (from baseline to timepoint of interest) was calculated at Year 1 and Year 2 (Year 2 data predominantly from SUSTAIN 6); interaction p-values indicated differences between subgroups. Results In the overall treatment population, the annual rate of eGFR change was 0.60 mL/min/1.73 m2 (95% confidence interval [CI]: 0.31;0.90; p<0.0001) lower with semaglutide vs placebo in Year 1. In the subgroup with an eGFR ≥60 mL/min/1.73 m2 at baseline, the ETD for semaglutide vs placebo at Year 1 was 0.48 mL/min/1.73 m2/year (95% CI: 0.13;0.82). Whereas, at Year 1, the subgroup with eGFR ≥30–<60 mL/min/1.73 m2 had an ETD of 1.07 mL/min/1.73 m2/year (95% CI: 0.46;1.68) (Table). Accordingly, a numerically larger difference in ETD was observed in the eGFR ≥30–<60 mL/min/1.73 m2 vs the eGFR ≥60 mL/min/1.73 m2 subgroup (not statistically significant; pinteraction=0.21).   Conclusion Semaglutide was associated with a significantly smaller decline in renal function compared with placebo in subjects across stages of impaired kidney function at baseline. Although benefits were observed in the overall population, the findings indicate that the primary benefit may be observed in those with established chronic kidney disease. Table Annual eGFR change with semaglutide or placebo and ETD between semaglutide and placebo in pooled SUSTAIN 6 and PIONEER 6 trials

scholarly journals Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies

2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Laura C. Coates ◽  
Johan K. Wallman ◽  
Dennis McGonagle ◽  
Georg A. Schett ◽  
Iain B. McInnes ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Pooled Analysis ◽  
Search Query ◽  
Two Phase ◽  
Pooled Data ◽  
Link Type ◽  
Full Resolution ◽  
Shift Analysis ◽  
Post Hoc ◽  
Future 2

Abstract Background Enthesitis is one of the psoriatic arthritis (PsA) domains. Patients with enthesitis are associated with worse outcomes than those without enthesitis. The effect of secukinumab on the resolution of enthesitis in patients with PsA was explored using pooled data from the FUTURE 2 and 3 studies. Method Assessments of enthesitis through week 104 used the Leeds Enthesitis Index. These post hoc analyses included resolution of enthesitis count (EC = 0), median time to first resolution of enthesitis (Kaplan-Meϊer estimate), and shift analysis (as observed) of baseline EC (1, 2, or 3–6) to full resolution (FR), stable (similar or reduction of EC), or worse (EC > baseline). Efficacy outcomes (ACR, PASI, HAQ-DI, SF-36 PCS, and DAS28-CRP) were assessed in patients with or without baseline enthesitis. Results are reported for secukinumab 300 and 150 mg in the overall population and by prior TNFi treatment. Results A total of 65% (466/712) of patients had baseline enthesitis. In the overall population, FR was achieved as early as week 16 in 65% (300 mg) and 56% (150 mg) versus 44% (placebo) patients, with further improvements to 91% (300 mg) and 88% (150 mg) at week 104. The majority (89%) of patients without enthesitis at baseline maintained this status at week 104. Median days to resolution of EC were shorter with secukinumab 300 and 150 mg versus placebo (57 and 85 vs 167 days, respectively). In patients with EC of 1 or 2, shift analysis from baseline to week 24 showed that more patients achieved FR with secukinumab 300 mg and 150 mg versus placebo, whereas no difference between secukinumab and placebo was shown in the more severe patients with EC of 3–6. Increases in proportions of patients with FR were observed with secukinumab irrespective of the severity of EC from baseline to week 104. Improvements in efficacy outcomes were similar in patients with or without enthesitis treated with secukinumab 300 mg. Conclusion Secukinumab provided early and sustained resolution of enthesitis in patients with PsA over 2 years. Secukinumab 300 mg provided higher resolution than 150 mg in patients with more severe baseline EC and showed similar overall efficacy in patients with or without enthesitis. Trial registration FUTURE 2: ClinicalTrials.gov, NCT01752634 (date of study registration: December 19, 2012), and EudraCT, 2012-004439-22 (date of study registration: December 12, 2012) FUTURE 3: ClinicalTrials.gov, NCT01989468 (date of study registration: November 21, 2013), and EudraCT, 2013-004002-25 (date of study registration: December 17, 2013)

scholarly journals EP38 Secukinumab provides sustained improvement of enthesitis in patients with ankylosing spondylitis: pooled analysis of four pivotal Phase 3 studies

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Nick Barkham ◽  
Georg Schett ◽  
Xenofon Baraliakos ◽  
Filip van den Bosch ◽  
Atul Deodhar ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Pooled Analysis ◽  
Stock Ownership ◽  
Research Support ◽  
Pivotal Phase ◽  
Mixed Effect ◽  
Pooled Data ◽  
Measurement Analysis ◽  
Effect Model ◽  
Post Hoc

Abstract Background Enthesitis can be a debilitating extra-articular spondyloarthritis manifestation that causes considerable pain and reduced quality of life. We evaluated the effect of secukinumab on axial and peripheral enthesitis in ankylosing spondylitis (AS) patients with baseline enthesitis (BLE) across all MASES sites (N = 13), axial MASES sites (N = 11; 13 MASES minus Achilles tendons [AT] [AxS]), peripheral sites (N = 6; AT + lateral condyles of humerus/femur [PS]) and the AT (N = 2) at Weeks 16 and 52. Methods This post-hoc analysis pooled data across four AS studies (MEASURE 1-4) from patients originally randomised to secukinumab 150 mg (approved AS dose), 300 mg (MEASURE 3 only) or placebo with BLE (MASES >0). Evaluations included mean change from baseline in MASES score, complete resolution (CR; MASES=0) and improvement from baseline in MASES score ≥5 counts. Mixed-effect model repeat measurement analysis was performed on change from baseline in MASES score and non-responder imputation for resolution of enthesitis at Week 16; data are reported as observed at Week 52. Results 355 (70.4%), 58 (76.3%) and 280 (72%) patients had BLE in the 150 mg, 300 mg and placebo groups, respectively. Baseline characteristics were comparable across groups. At Week 16, mean change from baseline for overall MASES and at AxS was greater for secukinumab 150 mg (−2.4, −2.3) and 300 mg (−2.9, −2.9) vs placebo (−1.9, −1.8; P < 0.05, P < 0.01). At Week 16, patients treated with secukinumab 150 mg (40.8%, 42.7%) and 300 mg (36.2%, 42.1%) vs placebo (28.9%, 30.1%) achieved CR of enthesitis at overall MASES and AxS. Secukinumab 150 mg and 300 mg were consistently associated with a higher mean change in MASES and CR of enthesitis at PS and AT vs placebo. More patients treated with secukinumab 150/300 mg vs placebo achieved a higher threshold of improvement (≥5 counts) in overall MASES at Week 16. Further improvements were observed for all endpoints at Week 52 (Table 1). Conclusion Secukinumab 150 mg and 300 mg were associated with a higher mean change in MASES and CR of enthesitis for overall MASES and at AxS vs placebo in AS patients at Week 16, which further improved through Week 52. Disclosures N. Barkham Grants/research support; Novartis, Eli Lilly, UCB, Celgene. G. Schett None. X. Baraliakos Consultancies; AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Janssen Biologics, Novartis, Pfizer, UCB Pharma, Galapagos. Member of speakers’ bureau; AbbVie, Chugai, Janssen, Novartis, Pfizer, UCB Pharma. Grants/research support; AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Chugai, Janssen, MSD, Novartis, Pfizer, Roche, UCB. F. van den Bosch Consultancies; AbbVie, Bristol-Myers Squibb, Galapagos, Janssen, Lilly, Merck, Novartis, Pfizer, UCB. Member of speakers’ bureau; AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Merck, Novartis, Pfizer, UCB. A. Deodhar Consultancies; AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen, Novartis, Pfizer, UCB. Grants/research support; AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, UCB. L.S. Gensler Consultancies; Novartis, Lilly, Janssen. Grants/research support; AbbVie, Amgen, UCB Pharma. M. Ǿstergaard Consultancies; AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, UCB. Member of speakers’ bureau; AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, UCB. Grants/research support; AbbVie, Celgene, Centocor, Merck, Novartis. S. Agawane Other; Employee of: Novartis. A. Das Gupta Other; Employee of: Novartis. S. Mpofu Other; Employee of: Novartis. T. Fox Other; Employee of: Novartis. A. Winseck Other; Employee of: Novartis. A. Shete Shareholder/stock ownership; Novartis. Other; Employee of: Novartis. B. Porter Shareholder/stock ownership; Novartis. Other; Employee of: Novartis.

A pooled analysis of the effects of asenapine on the persistent negative symptoms of schizophrenia

2011 ◽  
Vol 26 (S2) ◽  
pp. 1510-1510 ◽  
Author(s):  
S.G. Potkin ◽  
P. Phiri ◽  
J. Zhao ◽  
L. Alphs ◽  
R.W. Buchanan ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Symptom Assessment ◽  
Pooled Analysis ◽  
Double Blind ◽  
Once Daily ◽  
Pooled Data ◽  
Core Study ◽  
Treatment Changes ◽  
Study Participants ◽  
Persistent Negative Symptoms

IntroductionAsenapine and olanzapine reduced persistent negative symptoms (PNS) of schizophrenia in 2 double-blind, randomized 26-week studies and subsequent 26-week extensions; superiority of asenapine over olanzapine was observed in neither core study and only 1 extension.ObjectiveFurther explore the efficacy of asenapine on PNS using pooled data.AimDemonstrate superiority of asenapine over olanzapine on PNS.MethodsCore study participants were randomized to twice-daily asenapine 5 or 10 mg or once-daily olanzapine 5–20 mg; extension participants continued existing treatment. Changes from core study 16-item Negative Symptom Assessment (NSA-16) Scale baseline at Weeks 26 and 52 were estimated using MMRM.ResultsOf 949 treated participants (asenapine, 485; olanzapine, 464), 613 (277; 336) completed the core studies and 412 (170; 242) completed the extensions. Discontinuation due to lack of therapeutic effect was significantly greater with asenapine vs olanzapine for the first 26 weeks (13.6% vs 7.3%, p = 0.0016) and during the extension (5.5% vs 2.1%, p = 0.0458) for core and extension study participants, respectively. Between-group differences in least squares mean ± SE NSA-16 score change from core study baseline were significantly greater with asenapine at Week 52 for core (-14.6 ± 0.8 vs -12.6 ± 0.7; p = 0.0497) and extension (-16.5 ± 0.9 vs -13.6 ± 0.7; p = 0.0083) participants, but were not significant at Week 26.ConclusionsIn pooled analyses, asenapine and olanzapine reduced PNS, with statistical superiority of asenapine observed at Week 52 but not Week 26. These results should be interpreted in view of the fact that participants who entered the extensions did so without rerandomization.

MO129COMPARATIVE EFFECTIVENESS OF SGLT2I VERSUS DPP4I ON CARDIOVASCULAR AND RENAL OUTCOMES IN ROUTINE-CARE SETTINGS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Edouard Fu ◽  
Marco Trevisan ◽  
Vivekananda Lanka ◽  
Catherine M Clase ◽  
Yang Xu ◽  
...  
Keyword(s):  
Propensity Score ◽  
Kidney Function ◽  
Primary Outcome ◽  
Cox Regression ◽  
Routine Care ◽  
Major Adverse Cardiovascular Events ◽  
All Cause Mortality ◽  
Kidney Function Decline ◽  
Egfr Slope

Abstract Background and Aims While clinical trials have demonstrated the efficacy of SGLT2 inhibitors on preventing cardiovascular and renal damage, few studies have expanded this evidence to routine-care settings. Method We compared clinical outcomes of adults who started SGLT2i or DPP4i therapy in Stockholm, Sweden, during 2013-2019. The primary outcome was a composite of cardiovascular (CV) death and hospitalization for heart failure (HF). Secondary outcomes included major adverse cardiovascular events (MACE; composite of cardiovascular death, myocardial infarction, stroke), all-cause mortality and the rate of eGFR decline (eGFR slope). Propensity score weighted Cox regression was used to balance 55 variables and estimate intention-to-treat hazard ratios with 95% confidence intervals. Differences in eGFR slope were calculated with linear mixed models. Results We identified 7136 individuals starting SGLT2i and 13,618 starting DPP4i therapy. Median age was 64 years (37% women) and median eGFR 86 ml/min/1.73m2. During median follow-up of 2.1 years, 211 individuals developed the primary outcome, 269 experienced MACE and 178 died. After propensity score weighting, patients starting SGLT2i therapy were at lower risk for the composite of CV death/HF hospitalization (HR 0.71; 95% CI 0.53-0.94) compared with DPP4i, and showed a tendency towards lower MACE (0.84; 95% CI 0.67-1.04) and all-cause mortality (0.85; 95% CI 0.62-1.18). There were a median of 4 (interquartile range: 2-8) eGFR measurements during follow-up per patient to estimate their eGFR slopes. In adjusted models, new users of SGLT2i had a slower rate of kidney function decline compared with DPP4i (eGFR slope difference of 0.43 (95% CI 0.15-0.72) ml/min/1.73m2 per year). Results for the primary outcome were consistent across 7 pre-specified subgroups, including eGFR (eGFR ≥60: HR 0.79 [95% CI 0.57-1.08]; eGFR <60: HR 0.62 [0.38-0.99], p-value for interaction 0.40). Conclusion In patients undergoing routine care, initiation of SGLT2i was associated with fewer cardiovascular outcomes and less rapid kidney function decline compared with DPP4i initiation.

scholarly journals Can kidney parenchyma metabolites serve as prognostic biomarkers for long-term kidney function after nephrectomy for renal cell carcinoma? A preliminary study

2020 ◽  
Author(s):  
Barak Rosenzweig ◽  
Pedro Recabal ◽  
Caroline Gluck ◽  
Jonathan A Coleman ◽  
Katalin Susztak ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Kidney Function ◽  
Renal Cell ◽  
Blood Lipids ◽  
Prognostic Biomarkers ◽  
Metabolomics Data ◽  
Egfr Slope

Abstract Objective Nephrectomy, the standard of care for localized renal cell carcinoma (RCC), may lead to kidney function loss. Our goal was to identify prognostic biomarkers of postoperative renal function using metabolomics. Methods Metabolomics data from benign kidney parenchyma were collected prospectively from 138 patients with RCC who underwent nephrectomy at a single institution. The primary endpoint was the difference between the postoperative and preoperative estimated glomerular filtration (eGFR) rate divided by the elapsed time (eGFR slope). eGFR slope was calculated ∼2 years post-nephrectomy (GFR1), and at last follow-up (GFR2). A multivariate regularized regression model identified clinical characteristics and abundance of metabolites in baseline benign kidney parenchyma that were significantly associated with eGFR slope. Findings were validated by associating gene expression data with eGFR slope in an independent cohort (n = 58). Results Data were compiled on 78 patients (median age 62.6 years, 65.4% males). The mean follow-up was 25 ± 3.4 months for GFR1 and 69.5 ± 23.5 months for GFR2 and 17 (22%) and 32 (41%) patients showed eGFR recovery, respectively. Nephrectomy type, blood lipids, gender and 23 metabolites from benign parenchyma were significantly associated with eGFR slope. Some metabolites associated with eGFR slope overlapped with previously reported chronic kidney disease-related processes. Subgroup analysis identified unique ‘metabolite signatures’ by older age, nephrectomy type and preoperative eGFR. Conclusions Nephrectomy type, gender, blood lipids and benign parenchyma metabolites at nephrectomy were associated with long-term kidney function. On further study, these metabolites may be useful as potential biomarkers and to identify novel therapeutic targets for malignancy-associated renal disease.

Opicapone for Parkinson’s disease: clinical evidence and future perspectives

2021 ◽  
Author(s):  
Clémence Leung ◽  
Olivier Rascol ◽  
Margherita Fabbri
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Evidence ◽  
Open Label ◽  
Once Daily ◽  
Beneficial Effects ◽  
Long Acting ◽  
Post Hoc ◽  
Disease Stages ◽  
Off Time

Since 2016, opicapone (OPC), a potent third-generation, long-acting, once-daily, peripheral catechol-O-methyltransferase inhibitor, is approved as add-on to levodopa in Parkinson’s disease patients with motor fluctuations. OPC 50 mg has showed to be able in reducing OFF time by an average of about 60 min daily compared with placebo, to further reduce OFF-time of about 39 min, when switched from ENT to OPC and to be safe. These beneficial effects of OPC were maintained for 1 year. Recently, several post hoc analysis and few pilot observational open-label studies, have suggested its efficacy and wider applicability for different phenotypes of motor complications and for Parkinson’s disease stages. Here we review OPC applicability and perspectives, in the light of the more recently published analysis.

scholarly journals Effect of the Glucagon-like Peptide-1 Receptor Agonists Semaglutide and Liraglutide on Kidney Outcomes in Patients With Type 2 Diabetes: a Pooled Analysis of SUSTAIN 6 and LEADER Trials

Circulation ◽  
2021 ◽  
Author(s):  
Ahmed M. Shaman ◽  
Stephen C. Bain ◽  
George L. Bakris ◽  
John B. Buse ◽  
Thomas Idorn ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Estimated Glomerular Filtration Rate ◽  
Pooled Analysis ◽  
Trial Data ◽  
Protective Effects ◽  
Once Daily ◽  
Glucagon Like Peptide ◽  
Glucagon Like Peptide 1

Background: We assessed the effect of once-weekly semaglutide and once-daily liraglutide on kidney outcomes in type 2 diabetes (T2D). Methods: Pooled (N=12,637) and by-trial data from SUSTAIN 6 (N=3297) and LEADER (N=9340) were assessed for albuminuria change, annual slope of estimated glomerular filtration rate (eGFR) change, and time to persistent eGFR reduction (30%, 40%, 50%, and 57%) from baseline. Results: The median follow-up durations were 2.1 and 3.8 years for SUSTAIN 6 and LEADER, respectively. In the pooled analysis, semaglutide/liraglutide lowered albuminuria from baseline to 2 years post-randomization by 24% versus placebo (95% confidence interval [CI] [20%,27% ], p <0.001). Significant reductions were also observed in by-trial data analyses ( p <0.001 for all), the largest being with semaglutide 1.0 mg: 33% (95% CI [24%,40% ], p <0.001) at 2 years. With semaglutide 1.0 mg and liraglutide, eGFR slope decline was significantly slowed by 0.87 and 0.26 mL/min/1.73 m 2 /year ( p <0.0001 and p <0.001), respectively, versus placebo. Effects appeared larger in those with baseline eGFR <60 versus ≥60 mL/min/1.73m 2 ( p interaction =0.06 and 0.008 for semaglutide 1.0 mg and liraglutide, respectively). Semaglutide/liraglutide significantly lowered risk of persistent 40% and 50% eGFR reductions versus placebo (hazard ratio [HR] 0.86, 95% CI [0.75,0.99], p =0.039, and HR 0.80, 95% CI [0.66,0.97], p =0.023, respectively). Similar, non-significant, directional results were observed for 30% and 57% eGFR reductions (HR 0.92, 95% CI [0.84, 1.02], p =0.10, and HR 0.89, 95% CI [0.69, 1.13], p =0.34). In those with baseline eGFR 30−<60mL/min/1.73m 2 , the likelihood of persistent reduction for all thresholds was increased, ranging from a HR 0.71 for 30% reduction (95% CI [0.59,0.85], p =0.0003, pinteraction=0.017) to 0.54 for 57% reduction (95% CI [0.36,0.81], p =0.003, pinteraction=0.035). Conclusions: In patients with T2D, semaglutide/liraglutide offered kidney-protective effects, which appeared more pronounced in those with pre-existing chronic kidney disease.

scholarly journals Comparative Studies of the Effect of Different Types of Iron Tonics on Umbilical and Middle Cerebral Blood Flow in Cases of Moderate Iron Deficiency Anemia in Late Second Trimester of Pregnant Women

2021 ◽  
pp. 116-126
Author(s):  
Basma M. Elbehiry ◽  
Raghda A. El-Dakhakhni ◽  
Mohamed F. Dawood ◽  
Mohamed M. Esmail
Keyword(s):  
Umbilical Artery ◽  
Resistance Index ◽  
Post Treatment ◽  
Maternal Anemia ◽  
Once Daily ◽  
Post Hoc Analysis ◽  
Different Types ◽  
Doppler Indices ◽  
Post Hoc

Background: Maternal anemia is frequently associated with premature delivery, reduced neonatal weight, infant iron deficiency, neonatal death, and low Apgar scores at 1 min. It is also suspected to reduce the oxygen supply to the growing fetus, leading to the redistribution of fetal blood flow. This study aims to evaluate the effect of the different types of iron medications given to anemic patients on fetal Doppler indices namely umbilical artery and middle cerebral artery in the late second trimester of pregnancy. Materials and Methods: This cohort prospective study. This study conducted at department of obstetrics and gynecology at Tanta university hospital. Participants consisted of 90 pregnant women during their gestational age (20-28 weeks) they were attended or admitted to obstetric unit.divided into 3 groups. Lactoferrin group included 30 cases received 250 mg lactoferrin capsules once daily for 4 weeks. Iron amino acid chelated group included 30 cases received ferrous bis – glycine chelate (FeBC) 15 mg/day for 4 weeks. Ferrous fumarate group included 30 cases received 350 mg dried ferrous fumarate capsules once daily for 4 weeks. Pre-and post-treatment Doppler measurement of umbilical artery and middle cerebral artery parameter compared 4 weeks after the start of treatment for patients whose anemia successfully treated. Results: Post hoc analysis of maternal serum hemoglobin of the studied groups show insignificant different between the groups. Pre- and Post-treatment follow-up of resistance index (RI) of the studied groups, Pre- and Post-treatment follow-up of pulsatility index (PI) of the studied groups, Post hoc analysis of pulsatility index (PI) of the studied groups and Post hoc analysis of resistance index (RI) of the studied groups show insignificant different between groups. Conclusion: Based on our results, it can be concluded that cerebral vasodilatation due to severe maternal anemia is a reversible condition that can be corrected through the prompt treatment of anemia. Additionally, the three therapeutics tested in the current study showed a comparable effect in treating maternal anemia, with subsequent improvement of doppler indices.

scholarly journals Secukinumab Efficacy on Enthesitis in Patients with Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase 3 Studies

2021 ◽  
pp. jrheum.201111
Author(s):  
Georg Schett ◽  
Xenofon Baraliakos ◽  
Filip Van den Bosch ◽  
Atul Deodhar ◽  
Mikkel Østergaard ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Complete Resolution ◽  
Analysis Data ◽  
Pooled Analysis ◽  
Phase 3 ◽  
Pivotal Phase ◽  
Pooled Data ◽  
Randomized Controlled ◽  
Link Type ◽  
Post Hoc

Objective To assess the efficacy of secukinumab on axial and peripheral enthesitis in patients with ankylosing spondylitis (AS) using pooled data from randomized controlled phase 3 studies. Methods In this post-hoc analysis, data were pooled from patients originally randomized to secukinumab 150 mg, 300 mg, or placebo from phase 3 MEASURE 1-4 studies (ClinicalTrials.gov identifiers: NCT01358175, NCT01649375, NCT02008916 and NCT02159053). Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) was used for assessments of enthesitis through Week 52. Efficacy outcomes were mean change in MASES score and complete resolution (MASES=0) of enthesitis in patients with baseline MASES>0. Results A total of 693 (71.5%) patients had enthesitis at baseline in secukinumab 300 mg, 150 mg and placebo groups (58 [76.3%], 355 [70.4%] and 280 [72%]), respectively, out of 969 patients pooled in this analysis. At Week 16, mean change from baseline for overall MASES and enthesitis at axial MASES-sites was: secukinumab 300 mg (-2.9 [P<0.01] and -2.9 [P<0.01]); 150 mg (-2.4 [P<0.015] and -2.3 [P<0.05]), and placebo (-1.9 and -1.8), with improvements seen through Week 52. More than a third of secukinumab-treated patients (300 mg, 36.2% and 150 mg, 40.8%) achieved complete resolution of enthesitis at Week 16. Conclusion Secukinumab improved enthesitis at overall MASES and axial sites in patients with ankylosing spondylitis.

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