A report about a biological product for patients with atopic dermatitis.

 Have you heard of the medicine called a biological product? It is a practical application of the monoclonal antibody.
 There are various biological products available nowadays. Among them Xolair (Omalizumab) is the most promising for atopic dermatitis at present.

 Xolair was studied as a medicine for asthma. Patients with asthma often suffer from atopic dermatitis also. Some patients with asthma to whom Xolair was administered also improved their eczema. So doctors started to study the efficacy of the medicine for atopic dermatitis. Some reported Xolair was useful while the others reported not effective. There was no double blinded case-control study. The below report is the first double blinded case-control study about Xolair for atopic dermatitis though the population is small.

Immunologic Effects of Omalizumab in Children with Severe Refractory Atopic Dermatitis: A Randomized, Placebo-Controlled Clinical Trial. Iyengar SR,et al. Int Arch Allergy Immunol. 2013 Jun 27;162(1):89-93　　

 The number of patients was 8 at the age of 4-22. They were divided to two groups of placebo and Omalizumab administration.
 They were all refractory patients (“All patients had severe AD that had failed standard therapy.”）. Whole the treatment was discontinued one week before the first administration of the placebo or Omalizumab. The agent was administered by subcutaneous injection and the dosage of Omalizumab was 150-375mg every time. The frequency was every 2-4 weeks and the duration of treatment was 22 weeks.

 Total IgE, Free IgE, TARC and SCORAD values are picked up from the results of the article as the following table. How do you read the numerals?

 Omalizumab is an antibody to IgE. It binds to the patient’s IgE and inactivates it. The free IgE decreaseed and Th2 system also became inactivated.
 However, about the SCORAD which indicate the clinical severity of atopic dermatitis, the values decreased in both the placebo and Omalizumab groups. How should we understand the result?

 I consider there is a possibility that the placebo patients improved  by topical steroid withdrawal(TSW) for 22 weeks.

 In the article, the authors didn’t mention the result of the statistical analysis. So I did the matched Student’s t test to their results. The P value were as the following.
 

  At the 0.05% of the significance level, the placebo group improved while Omalizumab group didn’t improve.

 The author’s comment is as the following.
“The high rate of response to placebo has been well documented in these types of studies and, had any of the above published studies examining the clinical effects of anti-IgE included a placebo arm, a similar rate of response may have been seen.”

 Wait for a while. The phrase is likely to be skipped just carelessly but you ( the author) mentioned the patients were all refractory to the usual standard therapy, weren’t they? You admit such patients improved by the placebo treatment for 22 weeks and it is often the case with that kind of studies?

 Yes, atopic dermatitis has a tendency of natural healing. But the enrolled patients were “All patients had severe AD that had failed standard therapy.” I suppose you should not have forecasted their natural improvement before the study.

 The price of Xolair is about USD 350 per 75mg. It costs about USD 4200-21000 for 22 week treatment.
 Here I should clarify my stance about this therapy. I dare say I will buy Xolair and administer to my child if he or she suffers from the refractory atopic dermatitis. If I were a sufferer, I definitely buy the treatment. The problem about the above article is only the SCORAD result of the placebo group. The results of blood examination are clear and convincing. The significance of SCORAD is over 0.05 but I believe it will decrease if the population becomes larger.
 The cost is really high. But fortunately I can afford it. I will pay for the medicine even though there is a small risk of anaphylaxis or carcinogenicity due to immunosuppression. I take the merit heedless to the risk of this medicine.

 But I know well all the patients can’t try the treatment because of the financial problem. Don’t worry. You could also become improved only by discontinuance of the whole treatment for 22 weeks just like the patients of placebo group.

 Yes, it is the essence of the TSW. Patients feel strong anxiety to the situation of “nothing to do”. Placebo patients in the above article might have worsened temporarily but they could stand it because they thought they were through a treatment. Doctors could also stand the stressful situations because they thought they were scientifically right. Do consider. If the placebo patients remain worsened, the best scientific outcome could be obtained. Otherwise the doctors couldn’t stand seeing worsening patients without any treatment and must have recommended to resume topical corticosteroids.

 However,what a happy ending of the study! All patients became improved in the above article and the efficacy of TSW was also confirmed. A toast to the authors!

Sorry, the comment column is not available now. But the author believes readers can find some hints to overcome their own situations by the previous comments.