Abstract
A number of biological agents are available or being investigated for the treatment of asthma and rhinitis. The safety profiles of these biologic agents, which may modify allergic and immunological diseases, are still being elucidated. Subcutaneous allergen immunotherapy, the oldest biologic agent in current use, has the highest of frequency of the most serious and life-threatening reaction, anaphylaxis. It is also one of the only disease modifying interventions for allergic rhinitis and asthma. Efforts to seek safer and more effective allergen immunotherapy treatment have led to investigations of alternate routes of delivery and modified immunotherapy formulations. Sublingual immunotherapy appears to be associated with a lower, but not zero, risk of anaphylaxis. No fatalities have been reported to date with sublingual immunotherapy. Immunotherapy with modified formulations containing Th1 adjuvants, DNA sequences containing a CpG motif (CpG) and 3-deacylated monophospholipid A, appears to provide the benefits of subcutaneous immunotherapy with a single course of 4 to 6 preseasonal injections. There were no serious treatment-related adverse events or anaphylaxis in the clinical trials of these two immunotherapy adjuvants. Omalizumab, a monoclonal antibody against IgE, has been associated with a small risk of anaphylaxis, affecting 0.09% to 0.2% of patients. It may also be associated with a higher risk of geohelminth infection in patients at high risk for parasitic infections but it does not appear to affect the response to treatment or severity of the infection.Clinical trials with other biologic agents that have targeted IL-4/IL-13, or IL-5, have not demonstrated any definite serious treatment-related adverse events. However, these clinical trials were generally done in small populations of asthma patients, which may be too small for uncommon side effects to be identified. There is conflicting information about the safety TNF-alpha blocking agents, which have been primarily used in the treatment of rheumatoid arthritis, with serious infections, cardiovascular disease and malignancies being the most frequent serious adverse events. An unfavorable risk-benefit profile led to early discontinuation of a TNF-blocking agent in a double-blind placebo controlled of severe asthmatics.In summary, the risk of anaphylaxis and other treatment-related serious events with of all of the biological agents in this review were relatively small. However, most of the clinical trials were done in relatively small patient populations and were of relatively short duration. Long term studies in large patient populations may help clarify the risk-benefit profile of these biologic agents in the treatment of asthma.
Highlights
A number of therapeutic agents are available to treat the symptoms and inflammation associated with allergic rhinitis and asthma
Novel therapeutic approaches that have been used in the treatment of allergic rhinitis and asthma include: omalizumab, alternate immunotherapy routes such as sublingual, modified allergen immunotherapy vaccines, anti-interleukin 5, interleukin-4 variant and tumor necrosis factor (TNF-α) blocking agents
The intent of this paper is to review the safety of these novel therapeutic approaches
Summary
A number of therapeutic agents are available to treat the symptoms and inflammation associated with allergic rhinitis and asthma. After adjusting for baseline infection status, gender, age and study visit, there was http://www.aacijournal.com/content/5/1/4 a significant difference in the incidence of intestinal geohelminth infection between the 2 groups (adjusted OR 2.2 95% CI; 0.94-5.15, p = 0.035:) there was no increased morbidity in terms of laboratory or clinical adverse events in the Xolair® (omalizumab)-treated patients compared with the placebo group. In a double-blind placebo controlled trial 309 patients with severe, uncontrolled asthma randomized to one of 3 doses of the TNF-alpha blocking agent, golimumab administered subcutaneously (50, 100 or 200 mg) once a month or placebo, there was no significant difference in clinical efficacy between the 4 groups [64]. Serious bacterial infections: incidence of 0.07 to 0.09 per patient year compared 0.01 to 0.06 per control population year [70]
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