Allergy, Immunology, and ENT

FDA approves Arzerra in combination with chlorambucil for patients with CLL for whom fludarabine-based therapy is considered inappropriate

April 21, 2014

FDA has approved a new indication for ofatumumab (Arzerra, GlaxoSmithKline and Genmab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

Timothy Grass Pollen Allergen Extract approved by FDA

April 16, 2014

FDA has approved the Timothy Grass Pollen Allergen Extract (Grastek, Merck) sublingual tablet as immunotherapy to treat grass pollen-induced allergic rhinitis with or without conjunctivitis in children as young as 5 years of age and adults up to the age of 65. The tablet is a new option for patients who decline allergy shots.

Sublingual immunotherapy for allergic rhinitis and asthma effective, JAMA reports

April 02, 2013

In an examination of a type of treatment for allergic rhinitis and asthma that is used in Europe but not approved by FDA, researchers found moderate strength in the evidence from previous studies to support the use of sublingual immunotherapy for the treatment of these conditions, according to a review article in the March 27 issue of JAMA.

Leukotriene inhibitors associated with neuropsychiatric events

September 14, 2009

In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.

Drug Watch: Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis (September 2007) (PDF)

September 01, 2007

Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis

Use of broad-spectrum antibiotics during infancy associated with increased risk of pediatric asthma

September 01, 2007

Children who receive broad-spectrum antibiotics during their first year of life are at increased risk of developing childhood asthma.That was the conclusion of researchers who conducted a large, longitudinal, case-control study.

Privigen: New formulation recently approved by FDA for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura

September 01, 2007

A new formulation for immune globulin intravenous (human), 10% liquid, a polyvalent human immunoglobulin G approved for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura.

LOCSS trial: Once-daily fluticasone plus salmeterol superior to montelukast as step-down therapy for mild persistent asthma

August 01, 2007

In a multicenter, randomized, double-blind, controlled trial, investigators demonstrated that in patients whose asthma was well controlled with the use of fluticasone twice daily, switching to fluticasone plus salmeterol once daily did not increase the rates of treatment failure, but switching to montelukast once daily resulted in a 60% increased risk of treatment failure.

Budesonide plus formoterol associated with better control of persistent asthma control than gold standard therapy

August 01, 2007

In a 6-month, randomized, double-blind study, use of budesonide/formoterol as both maintenance and reliever therapy was demonstrated to provide better asthma control than either salmeterol/fluticasone plus terbutaline as needed or a fixed maintenance dose of budesonide/formoterol plus terbutaline as needed.

Inhaled corticosteroids may provoke oropharyngeal adverse events

June 01, 2007

In a meta-analysis, inhaled corticosteroids were associated with a risk of oropharyngeal adverse events.

Singulair: FDA approves new indication for montelukast

June 01, 2007

Montelukast, a leukotriene receptor antagonist, is now approved by FDA for the prevention of exercise-induced bronchoconstriction.

Biologic psoriasis treatment options expanding

May 01, 2007

New research presented at the AAD's 65th Annual Meeting regarding treatment of biologic psoriasis with adalimumab and efalizumab.

Aspirin may reduce the risk of newly diagnosed adult-onset asthma

February 01, 2007

A post-hoc analysis of the large, randomized, double-blind, placebo-controlled Physicians' Health Study found that the use of low-dose aspirin (ASA) on alternating days reduced the risk of adult-onset asthma by a statistically significant 22%.

Infliximab

November 01, 2006

Infliximab acts through the inhibition of tumor necrosis factor (TNF)-alpha, which is responsible for the induction of inflammatory cytokines, the enhancement of leukocyte migration, and the activation of neutrophil and eosinophil functional activity. Infliximab was approved on September 27, 2006, for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Topical calcipotriol/betamethasone dipropionate achieves quicker response against psoriasis compared with biological therapies

October 01, 2006

An ointment containing calcipotriol (50mcg/g) plus betamethasone diproprionate (0.5mg/g) demonstrated significant efficacy against psoriasis within 4 weeks compared with 12 weeks of biological therapy, regardless of disease severity, as measured by the Psoriasis Area and Severity Index (PASI), according to a meta-analysis recently reported in the International Journal of Dermatology.

Salmeterol/fluticasone combination lowers asthma exacerbations

July 01, 2006

A salmeterol/fluticasone combination (SFC) surpassed a formoterol/budesonide combination (FBC) in reducing the rate of moderate-to-severe exacerbations in patients with persistent asthma, according to a study published by the journal Respiratory Medicine.

Asthma patient hospitalization risk more than doubles with long-acting beta-agonist use of 3 months

July 01, 2006

A meta-analysis of 19 randomized, controlled clinical studies that lasted at least 3 months indicates that long-acting beta-agonists (LABAs) more than double the rates at which asthma patients may become hospitalized.

TELICAST trial of telithromycin produces split results in asthma treatment

July 01, 2006

A double-blind, randomized, placebo-controlled study of the ketolide telithromycin administered orally over a 10-day period to 278 asthma patients demonstrated a reduction in asthma symptoms, but did not show a significant treatment effect on patients' morning peak expiratory flow.

Tiotropium use in patients with COPD exacerbation improves airflow limitation and decreases health resource utilization

June 01, 2006

Tiotropium use in patients with chronic obstructive pulmonary disease (COPD) exacerbation led to decreased health resource utilization (HRU) and improved airflow limitation, according to a randomized, double-blind, multicenter, parallel group study published in the European Respiratory Journal.

Lower oral retinoid dose effective for psoriasis

June 01, 2006

A lower dose of the oral retinoid acitretin is effective for moderate-to-severe psoriasis and can minimize adverse effects, according to a study presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. Current practice is to administer the maximal tolerated dose of 25 mg to 50 mg acitretin daily.