scholarly journals Worsening of Lymphopenia during Apremilast Treatment

2016 ◽  
Vol 8 (3) ◽  
pp. 319-322 ◽  
Author(s):  
Antonios G.A. Kolios ◽  
Lars E. French ◽  
Alexander A. Navarini
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Private Practice ◽  
Laboratory Tests ◽  
Oral Route ◽  
Surrogate Markers ◽  
Regular Monitoring ◽  
Term Basis ◽  
Safety Signals

Apremilast is an oral phosphodiesterase IV inhibitor recently registered for the treatment of psoriasis and psoriatic arthritis in Switzerland and other countries. Even though it offers only moderate efficacy compared to biologics, many patients prefer drugs given by the oral route. Apremilast is frequently used in private practice, as it showed no relevant safety signals in clinical trials and often, laboratory tests are omitted completely. Here we report a patient who developed acute lymphopenia and worsening of psoriasis during apremilast treatment, which resolved with discontinuation of apremilast. We suggest that at least in prospective registries, that regular monitoring of laboratory surrogate markers should be performed on a long-term basis to detect rare but potentially important safety signals.

scholarly journals Long-term safety of certolizumab pegol in rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis and Crohn’s disease: a pooled analysis of 11 317 patients across clinical trials

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000942 ◽  
Author(s):  
Jeffrey R Curtis ◽  
Xavier Mariette ◽  
Cécile Gaujoux-Viala ◽  
Andrew Blauvelt ◽  
Tore K Kvien ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Crohn’S Disease ◽  
Psoriatic Arthritis ◽  
Crohn's Disease ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol ◽  
Major Adverse Cardiovascular Events ◽  
Expert Committee

ObjectiveTo review long-term certolizumab pegol (CZP) safety across all approved indications: rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), psoriasis (PSO) and Crohn’s disease (CD).MethodsData were pooled across 49 UCB-sponsored CZP clinical trials (27 RA, one axSpA, one PsA, five PSO, 15 CD) to August 2017. Serious adverse events (SAEs) of interest (infections, malignancies, autoimmunity/hypersensitivity events, major adverse cardiovascular events (MACE), gastrointestinal (GI) perforations, psoriasis events, laboratory abnormalities) and deaths were medically reviewed by an external expert committee, using predefined case rules. Incidence rates (IRs)/100 patient-years (PY) are presented by indication; standardised mortality and malignancy rates were calculated using WHO/GLOBOCAN/SEER databases. Pregnancies with maternal CZP exposure are also reported.ResultsOf 11 317 CZP-treated patients across indications (21 695 PY CZP exposure; maximum: 7.8 years), infections were the most common SAEs (overall IR: 3.62/100 PY; IRs ranged from 1.50/100 PY(PSO) to 5.97/100 PY(CD)). The IR for malignancies was 0.82/100 PY, including lymphoma (0.06/100 PY). MACE and GI perforation IRs in CZP-treated patients were 0.47/100 PY and 0.08/100 PY and were highest in RA and CD, respectively. Patients with PSO had the lowest SAE rates. The incidence of deaths and malignancies aligned with expected general population data.ConclusionThis extensive overview of the CZP safety profile in clinical trials, across all indications, provides large-scale confirmation of previous reports. No new safety signals or relevant non-disease-related laboratory abnormalities were identified. The study demonstrated some indication-specific differences in certain SAE rates that may be attributable to the underlying inflammatory disease.

scholarly journals SETTLEMENT OF A HIGH EMBANKMENT AND OVERPASS STRUCTURES IN OTTAWA

1969 ◽  
Vol 6 (1) ◽  
pp. 33-45 ◽  
Author(s):  
K. N. Burn
Keyword(s):  
Laboratory Tests ◽  
Pore Water Pressure ◽  
Water Pressure ◽  
Excess Pore Water Pressure ◽  
Earth Embankment ◽  
Term Basis ◽  
Spread Footings ◽  
Leda Clay ◽  
Applied Stresses

Settlement observations have been conducted over a 5-year period on a 20-ft-high earth embankment and 2 highway overpass structures founded on spread footings over a thick deposit of Leda clay. The applied stresses were considerably less than the overconsolidation pressure of the clay. In the five years since construction, settlements of approximately 12 cm have occurred, of which about 4 cm occurred immediately. The observed settlements are compared with settlement predictions on the basis of various types of laboratory tests. The observations indicate that significant settlements occur on a long-term basis and can be attributed to a slow yielding of the clay structure. Piezometers failed to detect any excess pore water pressure due to slow process of consolidation.

Treatment and secondary prevention of venous thromboembolism in cancer patients

2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

Socioeconomic Challenges faced by Basin’s People in India

Think India ◽  
2019 ◽  
Vol 22 (2) ◽  
pp. 296-304
Author(s):  
Biplab Tripathy ◽  
Tanmoy Mondal
Keyword(s):  
River Basin ◽  
High Tide ◽  
North East ◽  
The People ◽  
Term Basis ◽  
Major River ◽  
River Ganga ◽  
Basin Region ◽  
Basin Area

India is a subcontinent, there huge no of people lived in river basin area. In India there more or less 80% of people directly or indirectly depend on River. Ganga, Brahamputra in North and North East and Mahanadi, Govabori, Krishna, Kaveri, Narmoda, Tapti, Mahi in South are the major river basin in India. There each year due to flood and high tide lots of people are suffered in river basin region in India. These problems destroy the socio economic peace and hope of the people in river basin. There peoples are continuously suffered by lots of difficulties in sort or in long term basis. Few basin regions are always in high alert at the time of monsoon seasons. Sometime due to over migration from basin area, it becomes empty and creates an ultimate loss of resources in India and causes a dis-balance situation in this area.

The Efficacy of Anti-inflammatory Agents in the Prevention of Atrial Fibrillation Recurrences

2020 ◽  
Vol 28 (1) ◽  
pp. 137-151
Author(s):  
Homa Nomani ◽  
Sara Saei ◽  
Thomas P. Johnston ◽  
Amirhossein Sahebkar ◽  
Amir Hooshang Mohammadpour
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Therapeutic Option ◽  
General Rule ◽  
Promising Candidate ◽  
Term Basis ◽  
Inflammatory Drugs ◽  
Anti Inflammatory ◽  
Meta Analyses ◽  
Af Recurrence

: Several studies have indicated an association between inflammation and the recurrence of Atrial Fibrillation (AF), especially after ablation, which is a therapeutic option leading to local inflammation. On the other hand, each AF can lead to another AF, as a general rule. Thus, preventing recurrences of AF is extremely important for patient outcomes. In this paper, we attempted to review the effect of medicinal agents with anti-inflammatory properties on the prevention of AF recurrence. There are several randomized controlled trials (RCTs) and meta-analyses on the prevention of AF recurrence using agents with anti-inflammatory properties, which include steroids, colchicine, statins, and n-3 fatty acids (n-3 FA). Clinical trials evaluating the efficacy of anti-inflammatory drugs in preventing the recurrence of AF led to inconsistent results for corticosteroids, statins and n-3 FAs. These results may be related to the fact that inflammation is not the only factor responsible for triggering recurrences of AF. For example, the presence of structural, mechanical and electrical remodeling could potentially be the most important factors that trigger recurrences of AF but these factors have not been addressed in most of the reported studies. Therefore, future clinical trials are needed to compare the efficacy of anti-inflammatory drugs in AF patients with, or without other factors. For colchicine, a potent anti-inflammatory drug, there are limited studies. However, all the studies investigating colchicine in the context of AF were consistent and promising, especially when colchicine was used on a short-term basis following ablation in patients with paroxysmal AF. Therefore, colchicine could be a promising candidate for further clinical studies involving recurrent AF.

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