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ALK-Abello Sub-Lingual Immunotherapy Vaccine (SLIT)

 








For Australian & New Zealand medical professionals,
the latest information (as of 19/5/2010) on the availability and products of
ALK-Abello Sub-Lingual Immunotherapy Vaccines
can be obtained by viewing the relevant Restricted Access section of this website. 
To enter the Restricted Access section on ALK-Abello Sub-Lingual Immunotherapy Vaccines, click here.
To obtain your password for this restricted Access Section, contact AMS.

ALK-Abello Sub-Lingual Immunotherapy Vaccines

More than 20% of the world’s population suffers from allergy or allergic asthma and the numbers are rising. Allergic reactions in the eyes and respiratory system are most frequently due to grass or tree or weed pollens, house dust mites or animal danders.  In addition, foods may be allergens, as well as various Stinging Insect venoms and Drugs and Occupational allergens such as latex.

For many of these types of allergens, treatment with allergy Vaccines is not only possible but is highly effective, and is also the only means by which the underlying disease mechanism can be modified, rather than just smothering the symptoms of the body’s immune reaction to the allergen.

Traditionally, allergy vaccination has been achieved through the use of a program of Injections administered according to a standard Protocol (or Regime or Scheme). This is known as Sub-Cutaneous Immunotherapy; SCIT.

Although proven to be very effective in the treatment of Inhalant Allergy or Stinging Insect Venom Allergy, the use of SCIT has been limited by the Safety Factor, and to a lesser extent also by the Convenience Factor. Although serious adverse reactions with SCIT are rare, and even then usually caused by operator error, they can occur, and the risk of anaphylaxis must always be considered and catered for. This safety factor has lead to the usage of SCIT only for rhinitis and rhino-conjunctivitis cases rather than for cases with a moderate to strong feature of asthma. In addition, many paediatric patients would not consider SCIT due to the discomfort from the injections. Also the inconvenience factor of weekly visits for 3-4 months and then monthly doctor’s visits for 3 years would be a deterrent factor for some patients.

There is however an alternative form of vaccine administration that has been introduced to clinicians in various countries around the world and has become the standard vaccine form in several European countries. In the early 1990s ALK-Abelló was the first manufacturer to introduce Sub-Lingual Immuno-Therapy (SLIT). The early SLIT products were based on the same principle of an Initial Phase of increasing number of drops (1 to 10 drops over a period of 10 days) of the Vaccine solution under the tongue, followed by daily doses of the Maintenance Phase volume of 10 drops.

More recently, however, after increasing experience and documentation and experimentation, the new single dose product was launched in five European countries in 2005. The product and protocol is more convenient to use than the other SLIT products in the world market as there is no up-dosing; simply a fixed dose of 0.2ml (= approx 5-6 drops) once per day of a single potency, from Day 1 and the same every day for 3 years. Due to its great simplicity, compliance is therefore as good as can possibly be achieved for this patient administered treatment.

   

The clinical effect of SLIT has been shown in an increasing number of studies to be good, the safety profile excellent, compliance good, only mild adverse reactions (such as buccal itching), and in total very acceptable for patients, even including paediatric cases and controlled asthmatic cases.

In many European countries SLIT is now as popular and if not more popular than SCIT amongst Allergists and patients. For examople, in Europe as a whole, approximately half of all new patients going on to allergen immunotherapy utilise either Sub-Lingual Immunotherapy Drops or the latest generation Sub-Lingual Immunotherapy Tablets. In Italy this percentage is as high as 70%. There is increasing acceptance amongst Specialist Allergists in Australasia, mirroring the great acceptance and usage in many parts of Europe.

The World Allergy Organisation has in December 2009 published a Position Paper on Sub-Lingual Immunotherapy, that reviews all the medical research and publications, and makes the latest recommendations. It is in general very suportive of SLIT as a treatment modaility that is every bit as effective as the Injection Immunotherapy but with far greater Safety and Convenience.

There are several advantages with Sub-Lingual Immunotherapy in principle. 

  1. The greater patient acceptance of drops under the tongue compared to injections; so Sub-Lingual Immunotherapy is more acceptable to children in particular.  
  2. As the drops are dispensed by the patient at home, then the monthly visits to the doctor is not necessary except once every 6 to 12 months or more for assessment. This means far greater convenience, no time off work or school, and less cost for doctor’s visits.
  3. Reduced severity & range of side effects; usually only transient and mild such as buccal itching.
  4. Vastly improved safety, so that asthmatic patients (lower airway disease), or at least patients with an asthma component to their rhino-conjunctivitis (upper airway disease), can now be considered as candidates for Immunotherapy. 

There is however a major disadvantage to Sub-Lingual Immunotherapy; the cost of the Sub-Lingual Vaccine is approximately four times greater than for the Injection Vaccine, (at approximately $2,800 compared to $700) for the full three year course of treatment. The reasons for the greater cost are many, but principally because the concentration of the allergen in the Sub-Lingual Vaccine needs to be many times greater due to the less efficient method of buccal absorption compared to injection. Also the SLIT vaccines are newer and so more expensive to develop and their period since launch has not allowed the recoupment of the earlier costs. 

 

However, the increased cost to the patient of the Vaccine product itself is largely offset by the great reduction in costs for the doctor’s visits and the cost of the injections and the costs of inconvenience of more than 50 doctor visits over 3 years. In fact, the total cost for the three year course of Immunotherapy by Sub-Lingual drops can indeed be not so much greater than for Injection Immunotherapy. Further details of prices and costs are available on request.

 

One other cost factor that should be considered is the fact that as the Immunotherapy becomes increasingly effective as the treatment progresses, then there is a corresponding reduction or even cessation in the use of symptomatic medication such as anti-histamines and bronchodilators and steroids.

 Another feature of this Sub-Lingual Vaccine is that a personalised mix of allergens for an individual is not possible, so if the patient is highly sensitised to more than one allergen, such as Grass Pollen and House Dust Mite, then the doctor should consider the following options:

     1. Using two separate Sub-Lingual Vaccines directed against either allergen, or

     2. Treating only the one major allergen with one Vaccine, or

     3. Not choosing Sub-Lingual Immunotherapy at all.

Remember, that as the Vaccine against the one allergen becomes increasingly effective there is a general reduction in the IgE response to other allergens as well, due to a suppression of the IgE-manufacturing process in that patient. This is why patients on Immunotherapy against one allergen most usually not only also successfully treat other allergens to which they are simultaneously sensitised, but also go on to have fewer and weaker sensitivities to other allergens in future years.

 

Note that due to the vastly better Safety Profile of SLIT compared to Injection Vaccines, then therapy for Grass Pollen-allergic patients can be ongoing and even be started during the Pollen Season.

One other important factor with Sub-Lingual immunotherapy is Patient Compliance. If the three year course is not completed then the clinical benefit is proportionately reduced. Similarly, a patient must take the daily dose every day regularly, in order to achieve the required stimulation of the immune system. The latest dosage schedule for Sub-Lingual Immunotherapy Vaccines as nutilised by the ALK-Abello Sub-Lingual Vaccine means that the patient starts on Day 1 with the regular dosage of 0.2ml (= approx 5-6 drops)  from the single-use plastic ampoule, and continues daily with one ampoule per day for the full three years of the treatment course. There is therefore no up-dosing, so there is no need to change the volume of the dose, or to change the strength of the solution, or any other calculations or manipulations. This great simplicity means minimal errors or missed doses. It is also very easy for a parent to check a child's usage; by counting the unused sachets & ampoules compred to the scheduled usage.

 

The relative advantages and disadvantages of Sub-Lingual immunotherapy Vaccines compared to Injection Vaccines should be discussed with a Specialist Allergist.

A list of Specialist Allergists in Australia is available at http://www.allergy.org.au.

 

There are two different commercial brands of Sub-Lingual Immunotherapy vaccine available in Australia (and New Zealand).

The statements above are pertinent to the SLIT vaccine manufactured by ALK-Abello and distributed in Australia by AMS.

The ALK-Abello SLIT Vaccine is particularly advantageous due to the following features:

 

1 Once daily dosing        Not alternate days or 3 times a week
2 No Updosing; simply one ampoule per day No complex Updosing
3 Room Temperature storage of the Vaccine No need for Refrigeration, e.g. on holidays or travel
4 Sweet taste, of Glycerol    No nasty Phenol taste
5 Excellent Patient Compliance          Due to Ease and Simplicity and Convenience
6 Easy-to-use and convenient Packaging   Sachets & Ampoules, instead of Pumps
7 Superior Safety Profile          No Anaphylaxis, ever
8 Unequalled Convenience        Ordering, Delivering, Payment, Dosing
9 Most modern SLIT Vaccine   Most modern Dosing and most modern Packaging
10 Overall, the best SLIT Vaccine available in Australia.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Further information on this Sub-Lingual Immunotherapy Vaccine can be found on the corporate websites of ALK-Abello at:

          1. www.alk-abello.com for the HQ Corporate website

          2. www.alk-abello-us.com for the USA Subsidiary Corporate website

 

For further information:

Steve Lee                                                
Allergy Division Manager                     
Mob: 0448-022855
Tel: 02-9882 3666
Fax: 02-9882 3999
E-mail: slee@amsl.com.au                 

Last updated 19th May 2010