Einsatz von Secukinumab bei Patienten mit Psoriasis und Psoriasis-Arthritis – Ergebnisse einer nichtinterventionellen Studie unter Praxisbedingungen (SERENA-Studie)

Karger Kompass Dermatologie ◽

10.1159/000520396 ◽

2021 ◽

pp. 1-3

Author(s):

Michael Sticherling

Keyword(s):

Observational Study ◽

Real World ◽

Human Monoclonal Antibody ◽

Rapid Onset ◽

Onset Of Action ◽

The Real ◽

Interleukin 17A ◽

Favourable Safety ◽

Favourable Safety Profile

Introduction: Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications. Methods: SERENA is an ongoing, longitudinal, observational study conducted at 438 sites across Europe in patients with moderate to severe plaque PsO, active PsA or active AS. Patients should have received at least 16 weeks of secukinumab treatment before enrolment in the study. Results: Overall 2800 patients were included in the safety set; patients with PsA (N = 541) were older than patients with PsO (N = 1799) and patients with AS (N = 460); patients with PsO had a higher mean body weight than patients with PsA and patients with AS; and patients with PsO and patients with AS were predominantly male. Time since diagnosis was longer in patients with PsO compared with patients with PsA and patients with AS, and about 40% of patients were either current or former smokers. The proportion of obese patients (body mass index ≥ 30 kg/m2) was similar across indications. Patients were treated with secukinumab for a mean duration of 1 year prior to enrolment (range 0.89–1.04). The percentages of patients with prior biologics exposure were 31.5% PsO, 59.7% PsA and 55% AS. The percentages of patients prescribed secukinumab monotherapy were 75% (n = 1349) in PsO, 48.2% (n = 261) in PsA and 48.9% (n = 225) in AS groups. Conclusion: Baseline demographics of the study population are consistent with existing literature. This large observational study across all secukinumab indications will provide valuable information on the long-term effectiveness and safety of secukinumab in the real-world setting.

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Einsatz von Secukinumab bei Patienten mit Psoriasis und Psoriasis-Arthritis – Ergebnisse einer nichtinterventionellen Studie unter Praxisbedingungen (SERENA-Studie)

Karger Kompass Autoimmun ◽

10.1159/000518345 ◽

2021 ◽

pp. 1-3

Author(s):

Michael Sticherling

Keyword(s):

Observational Study ◽

Real World ◽

Human Monoclonal Antibody ◽

Rapid Onset ◽

Onset Of Action ◽

The Real ◽

Interleukin 17A ◽

Favourable Safety ◽

Favourable Safety Profile

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Comparison of long-term efficacy, tolerability, and safety of oxcarbazepine, lamotrigine, and levetiracetam in patients with newly diagnosed focal epilepsy: An observational study in the real world

Epilepsy Research ◽

10.1016/j.eplepsyres.2020.106408 ◽

2020 ◽

Vol 166 ◽

pp. 106408

Author(s):

Rong Li ◽

Qin Zhou ◽

Shuchun Ou ◽

Yuxuan Wang ◽

Yudan Li ◽

...

Keyword(s):

Observational Study ◽

Real World ◽

Focal Epilepsy ◽

Newly Diagnosed ◽

The Real ◽

Term Efficacy

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Long-term safety and efficacy of alogliptin, a DPP-4 inhibitor, in patients with type 2 diabetes: a 3-year prospective, controlled, observational study (J-BRAND Registry)

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2020-001787 ◽

2021 ◽

Vol 9 (1) ◽

pp. e001787

Author(s):

Kohjiro Ueki ◽

Yukio Tanizawa ◽

Jiro Nakamura ◽

Yuichiro Yamada ◽

Nobuya Inagaki ◽

...

Keyword(s):

Type 2 Diabetes ◽

Observational Study ◽

Real World ◽

Safety And Efficacy ◽

The Real ◽

Real World Setting ◽

Group A ◽

Group B

IntroductionGiven an increasing use of dipeptidyl peptidase-4 (DPP-4) inhibitors to treat patients with type 2 diabetes mellitus in the real-world setting, we conducted a prospective observational study (Japan-based Clinical Research Network for Diabetes Registry: J-BRAND Registry) to elucidate the safety and efficacy profile of long-term usage of alogliptin.Research design and methodsWe registered 5969 patients from April 2012 through September 2014, who started receiving alogliptin (group A) or other classes of oral hypoglycemic agents (OHAs; group B), and were followed for 3 years at 239 sites nationwide. Safety was the primary outcome. Symptomatic hypoglycemia, pancreatitis, skin disorders of non-extrinsic origin, severe infections, and cancer were collected as major adverse events (AEs). Efficacy assessment was the secondary outcome and included changes in hemoglobin A1c (HbA1c), fasting blood glucose, fasting insulin and urinary albumin.ResultsOf the registered, 5150 (group A: 3395 and group B: 1755) and 5096 (3358 and 1738) were included for safety and efficacy analysis, respectively. Group A patients mostly (>90%) continued to use alogliptin. In group B, biguanides were the primary agents, while DPP-4 inhibitors were added in up to ~36% of patients. The overall incidence of AEs was similar between the two groups (42.7% vs 42.2%). Kaplan-Meier analysis revealed the incidence of cancer was significantly higher in group A than in group B (7.4% vs 4.8%, p=0.040), while no significant incidence difference was observed in the individual cancer. Multivariate Cox regression analysis revealed that the imbalanced patient distribution (more elderly patients in group A than in group B), but not alogliptin usage per se, contributed to cancer development. The incidence of other major AE categories was with no between-group difference. Between-group difference was not detected, either, in the incidence of microvascular and macrovascular complications. HbA1c and fasting glucose decreased significantly at the 0.5-year visit and nearly plateaued thereafter in both groups.ConclusionsAlogliptin as a representative of DPP-4 inhibitors was safe and durably efficacious when used alone or with other OHAs for patients with type 2 diabetes in the real world setting.

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OC.12.2 THE REAL-WORLD LONG-TERM EFFECTIVENESS OF VEDOLIZUMAB IN INFLAMMATORY BOWEL DISEASES: A SINGLE CENTER OBSERVATIONAL STUDY

Digestive and Liver Disease ◽

10.1016/s1590-8658(19)30202-6 ◽

2019 ◽

Vol 51 ◽

pp. e109

Author(s):

F.S. Macaluso ◽

A. Croce ◽

R. Orlando ◽

M. Ventimiglia ◽

C. Sapienza ◽

...

Keyword(s):

Observational Study ◽

Real World ◽

Inflammatory Bowel Diseases ◽

Single Center ◽

The Real ◽

Bowel Diseases ◽

Inflammatory Bowel ◽

Single Center Observational Study

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QT changes of unforeseen implications and bedaquiline: an observational study

10.22541/au.160671430.07816312/v1 ◽

2020 ◽

Author(s):

Sandip Mukhopadhyay ◽

Samya Dutta ◽

Rupam Ta

Keyword(s):

Adverse Events ◽

Observational Study ◽

Real World ◽

Adverse Reactions ◽

Serious Adverse Events ◽

Serious Adverse Event ◽

The Real ◽

Baseline Values ◽

Access Program

Background: Bedqauiline (BDQ) is a relatively new agent for multidrug (MDR) and extremely drug resistant (XDR) TB. It is important to look for cardiac safety and the bizarre adverse reactions after initiation of the drugs from the real world studies. Methods: An observational study was conducted on the institutionalized MDR and XDR patients under the conditional access program of BDQ in India. Daily ECG, adverse events and change in laboratory values for first two weeks were recorded with mortality and serious adverse events till first three months of initiation of BDQ containing regimen. Results: Among the total of 49 patients, nausea (n=33) was the most reported side effect. Though a mean rise of QTcF (12%) was noted after 14 days, individually, both prolongations (QTcF >440 ms) and shortening (from baseline values) of QTcF were noted in 95.92% (n=47) and 89.8% (n=44) patients. Three distinct QT patterns noted in ECG were, a) initial rise then fall (n=8), b) initial fall then rise (n=9) and c) rise followed by further rise (32). There was no serious adverse event leading to drug withdrawal or mortality in the first three months. Conclusions: Prolongation of QTcF occurs in alarming numbers during first two weeks of BDQ therapy as well as shortened QT. However, BDQ was otherwise tolerated well by the real world MDR & XDR-TB patients in short term. Intensive ECG and clinical monitoring is recommended to detect possible serious implications of such ECG changes in the long term.

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P703 The real-world long-term effectiveness of vedolizumab in inflammatory bowel diseases: a single-centre observational study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjy222.827 ◽

2019 ◽

Vol 13 (Supplement_1) ◽

pp. S472-S473

Author(s):

F S Macaluso ◽

A Croce ◽

R Orlando ◽

M Ventimiglia ◽

C Sapienza ◽

...

Keyword(s):

Observational Study ◽

Real World ◽

Inflammatory Bowel Diseases ◽

Single Centre ◽

The Real ◽

Bowel Diseases ◽

Inflammatory Bowel

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Real-world effectiveness of post-trastuzumab emtansine treatment in patients with HER2-positive, unresectable and/or metastatic breast cancer: a retrospective observational study (KBCSG-TR 1917)

BMC Cancer ◽

10.1186/s12885-021-08504-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Takahiro Nakayama ◽

Tetsuhiro Yoshinami ◽

Hiroyuki Yasojima ◽

Nobuyoshi Kittaka ◽

Masato Takahashi ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Observational Study ◽

Real World ◽

Metastatic Breast ◽

Trastuzumab Emtansine ◽

Her2 Positive ◽

The Real ◽

Her2 Positive Breast Cancer ◽

Positive Breast Cancer

Abstract Background Trastuzumab emtansine (T-DM1) is a second-line standard therapy for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Evidence regarding post–T-DM1 treatments is currently lacking. We evaluated the effectiveness of post–T-DM1 drug therapy in patients with HER2-positive, unresectable and/or metastatic breast cancer. Methods In this multicenter, retrospective, observational study, real-world clinical data of female patients with HER2-positive breast cancer who had a history of T-DM1 treatment were consecutively collected from five sites in Japan. We investigated the effectiveness of post–T-DM1 therapy by evaluating the real-world progression-free survival (rwPFS), time to treatment failure (TTF), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Tumor response was assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) guidelines. Subgroup and exploratory analyses according to background factors were also undertaken. Results Of the 205 patients who received T-DM1 treatment between 1 January 2014 and 31 December 2018, 128 were included in this study. Among the 128 patients analyzed, 105 (82%) patients received anti-HER2 therapy and 23 (18%) patients received regimens without anti-HER2 therapy. Median (95% confidence interval [CI]) rwPFS, TTF, and OS were 5.7 (4.8–6.9) months, 5.6 (4.6–6.4) months, and 22.8 (18.2–32.4) months, respectively. CBR and ORR (95% CI) were 48% (38.8–56.7) and 23% (15.1–31.4), respectively. Cox-regression analysis showed that an ECOG PS score of 0, a HER2 immunohistochemistry score of 3+, recurrent type, ≥12 month duration of T-DM1 therapy, and anti-HER2 therapy were independent variables for rwPFS. An exploratory subgroup analysis of regimens after T-DM1 showed that those with anti-HER2 therapy had a median rwPFS of 6.3 and those without anti-HER2 therapy had a median rwPFS of 4.8 months. Conclusions In the real-world setting in Japan, several post–T-DM1 regimens for patients with unresectable and/or metastatic HER2-positive breast cancer, including continuation of anti-HER2 therapy, showed some effectiveness; however, this effectiveness was insufficient. Novel therapeutic options are still needed for further improvement of PFS and OS in later treatment settings. Trial registration UMIN000038296; registered on 15 October 2019.

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Alemtuzumab in the long-term treatment of relapsing-remitting multiple sclerosis: an update on the clinical trial evidence and data from the real world

Therapeutic Advances in Neurological Disorders ◽

10.1177/1756285617722706 ◽

2017 ◽

Vol 10 (10) ◽

pp. 343-359 ◽

Cited By ~ 58

Author(s):

Tjalf Ziemssen ◽

Katja Thomas

Keyword(s):

Multiple Sclerosis ◽

Adverse Events ◽

Mechanism Of Action ◽

Real World ◽

Continuous Treatment ◽

The Real ◽

Relapsing Remitting ◽

Remitting Multiple Sclerosis ◽

Relapsing Remitting Multiple Sclerosis

Alemtuzumab is a humanized monoclonal antibody approved for the treatment of relapsing-remitting multiple sclerosis (RRMS), given as two annual courses on five consecutive days at baseline and on three consecutive days 12 months later. Here we provide an update on the long-term efficacy and safety of alemtuzumab in RRMS, including real-world experience, and advances in our understanding of its mechanism of action. Recent data from the phase II/III extension study have demonstrated that alemtuzumab reduces relapse rates, disability worsening, and the rate of brain volume loss over the long term, with many patients achieving no evidence of disease activity. In high proportions of patients, preexisting disability remained stable or improved. Alemtuzumab is associated with a consistent safety profile over the long term, with no new safety signals emerging and the overall annual incidence of reported adverse events decreasing after the first year on treatment. Acyclovir prophylaxis reduces herpetic infections, and monitoring has been shown to mitigate the risk of autoimmune adverse events, allowing early detection and overall effective management. Data from clinical practice and ongoing observational studies are providing additional information on the real-world use of alemtuzumab. Recent evidence on the mechanism of action of alemtuzumab indicates that in addition to its previously known effects of inducing depletion and repopulation of T and B lymphocytes, it also results in a relative increase of cells with memory and regulatory phenotypes and a decrease in cells with a proinflammatory signature, and may further promote an immunoregulatory environment through an impact on other innate immune cells (e.g. dendritic cells) that play a role in MS. These effects may allow preservation of innate immunity and immunosurveillance. Together, these lines of evidence help explain the durable clinical efficacy of alemtuzumab, in the absence of continuous treatment, in patients with RRMS.

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Does Baseline On-treatment Platelet Reactivity Impact Long-term Prognosis in Patients with Acute Coronary Syndrome and Thrombocytopenia Who Underwent Percutaneous Coronary Intervention?

10.21203/rs.3.rs-236763/v1 ◽

2021 ◽

Author(s):

Ru Liu ◽

Tianyu Li ◽

Deshan Yuan ◽

Yan Chen ◽

Xiaofang Tang ◽

...

Keyword(s):

Percutaneous Coronary Intervention ◽

Acute Coronary Syndrome ◽

Real World ◽

Cox Regression ◽

Platelet Reactivity ◽

Coronary Intervention ◽

The Real ◽

Coronary Syndrome ◽

Percutaneous Coronary

Abstract Objectives: This study analyzed the association between on-treatment platelet reactivity and long-term outcomes of patients with acute coronary syndrome (ACS) and thrombocytopenia (TP) in the real world. Methods: A total of 10724 consecutive cases with coronary artery disease who underwent percutaneous coronary intervention (PCI) were collected from January to December 2013. Cases with ACS and TP under dual anti-platelet therapy were enrolled from the total cohort. 5-year clinical outcomes were evaluated among cases with high on-treatment platelet reactivity (HTPR), low on-treatment platelet reactivity (LTPR) and normal on-treatment platelet reactivity (NTPR), tested by thromboelastogram (TEG) at baseline. Results: Cases with HTPR, LTPR and NTPR accounted for 26.2%, 34.4% and 39.5%, respectively. Cases with HTPR were presented with the most male sex, lowest hemoglobin level, highest erythrocyte sedimentation rate and most LM or three-vessel disease, compared with the other two groups. The rates of 5-year all-cause death, major adverse cardiovascular and cerebrovascular events (MACCE), cardiac death, myocardial infarction (MI), revascularization, stroke and bleeding were all not significantly different among three groups. Multivariable Cox regression indicated that, compared with cases with NTPR, cases with HTPR were not independently associated with all endpoints, as well as cases with LTPR (all P>0.05). Conclusions: In patients with ACS and TP undergoing PCI, 5-year all-cause death, MACCE, MI, revascularization, stroke and bleeding risk were all similar between cases with HTPR and cases with NTPR, tested by TEG at baseline, in the real world. The comparison result was the same between cases with LTPR and NTPR.

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