Most Read Articles
one year ago
Age at onset significantly influences long-term clinical outcomes and health-related quality of life in paediatric ischaemic stroke survivors based on a study.
Elvira Manzano, one year ago
Valsartan/sacubitril (formerly LCZ696), recently approved by the US Food and Drug Administration for treating heart failure, may also be beneficial for reducing blood pressure (brachial and central aortic pressure) as well as arterial stiffness compared with angiotensin receptor blocker olmesartan.
one year ago
New drug applications approved by US FDA as of 16 - 31 Dec 2015 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
Catherine J Calderwood, MA (Cantab), MRCOG; Omar I Thanoon, MRCOG, 3 years ago

One of the many early physiological adaptations of pregnancy involves changes in the coagulation system, which promote coagulation and impair fibrinolysis. The physiological goal is to prepare for the haemostatic challenge of delivery. A ‘side effect’ of this change is an increased risk of thrombosis. All pregnant women are therefore at risk of thrombosis, compared with non-pregnant women. This risk is manifest from early in the first trimester until 4−6 weeks post partum.

Tofacitinib may be a promising therapeutic option for AS

Elvira Manzano
11 months ago
The oral Janus kinase (JAK) inhibitor tofacitinib may be a promising therapeutic option for patients with ankylosing spondylitis (AS), according to an expert who presented results from a phase II study that was touted as the first to demonstrate the efficacy of a JAK inhibitor in AS. 

Tofacitinib demonstrated greater clinical and imaging efficacy vs placebo in reducing the signs and symptoms of AS, said lead investigator Professor Désirée van der Heijde from the Leiden University Medical Centre in Leiden, The Netherlands. “Our data are quite consistent if you look at objective measures of response. There was a clear dose-response [relationship] in all clinical imaging outcome measures at week 12.”  

In the Bayesian Emax model analysis, patients taking tofacitinib 5 and 10 mg twice daily had a predicted 22.9 and 27.3 percent higher response in ASAS20 (improvement of at least 20 percent in the Assessment in Ankylosing Spondylitis Response Criteria at week 12) versus placebo. Those taking tofacitinib 2 mg twice daily had a 15.8 percent higher response in the ASAS20. [EULAR Congress 2016, abstract OP0002]

In addition, there was an improvement in MRI SPARCC (Spondyloarthritis Research Consortium of Canada) scores with tofacitinib, particularly in the 5 mg and 10 mg groups. There was almost no change in the SPARCC scores in the placebo group.

Patients in the study were randomized to tofacitinib 2mg, 5 mg, or 10 mg twice daily (n=52) or placebo (n=51) for 12 weeks and followed for an additional 4 weeks.  Mean disease duration at baseline was 6.3 years. Over 85 percent of patients were HLA-B27 positive and a fairly large proportion of patients were taking disease-modifying antirheumatic drugs (DMARDs).

There were no new safety signals with tofacitinib beyond those observed in other rheumatic diseases. Dose-dependent changes in laboratory outcomes were observed in the tofacitinib groups but levels returned to baseline at study end. Also very few patients in the tofacitinib groups discontinued treatment.

Given these promising results, further investigation of JAK inhibitors for AS in large phase III trials is warranted.

Tofacitinib is FDA-approved for rheumatoid arthritis and has been explored in several phase III studies for the treatment of psoriasis.

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Most Read Articles
one year ago
Age at onset significantly influences long-term clinical outcomes and health-related quality of life in paediatric ischaemic stroke survivors based on a study.
Elvira Manzano, one year ago
Valsartan/sacubitril (formerly LCZ696), recently approved by the US Food and Drug Administration for treating heart failure, may also be beneficial for reducing blood pressure (brachial and central aortic pressure) as well as arterial stiffness compared with angiotensin receptor blocker olmesartan.
one year ago
New drug applications approved by US FDA as of 16 - 31 Dec 2015 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
Catherine J Calderwood, MA (Cantab), MRCOG; Omar I Thanoon, MRCOG, 3 years ago

One of the many early physiological adaptations of pregnancy involves changes in the coagulation system, which promote coagulation and impair fibrinolysis. The physiological goal is to prepare for the haemostatic challenge of delivery. A ‘side effect’ of this change is an increased risk of thrombosis. All pregnant women are therefore at risk of thrombosis, compared with non-pregnant women. This risk is manifest from early in the first trimester until 4−6 weeks post partum.