Recombinant interferon gamma therapy for atopic dermatitis

Jon Hanifin, L. C. Schneider, D. Y M Leung, C. N. Ellis, H. S. Jaffe, A. E. Izu, L. R. Bucalo, S. E. Hirabayashi, Susan Tofte, G. Cantu-Gonzales, H. Milgrom, M. Boguniewicz, K. D. Cooper

Research output: Contribution to journalArticle

253 Citations (Scopus)

Abstract

Background: Atopic dermatitis is characterized by immunologic abnormalities including evidence for reduced interferon gamma production. Therapeutic options for treatment of atopic dermatitis are limited and unsatisfactory. Previous open trials have suggested efficacy for recombinant interferon-gamma (rIFN-γ) in treatment of severe atopic dermatitis. We describe the results of treatment with rIFN-γ, assessing clinical, immunologic, and laboratory safety parameters in 83 patients with moderate to severe atopic dermatitis. Objective: Our purpose was to determine in a randomized, placebo-controlled, double-blind multicenter study the effects of recombinant human interferon gamma therapy in patients with atopic dermatitis. Methods: Patients received 50 μg/m2 rIFN-γ (n = 40) or placebo (n = 43) by daily subcutaneous injection for 12 weeks. Seventy-eight patients completed the treatment course; two patients receiving rIFN-γ (one because of constitutional side effects) and three receiving placebo discontinued treatment before completion. Physician and patient overall response evaluations, clinical severity scores, body surface area involvement, and laboratory parameters were monitored throughout the trial. Results: Patients in both treatment groups were similar except that the rIFN-γ group was older and had a longer disease duration. Forty-five percent of rIFN-γ-treated patients and 21% of placebo-treated patients achieved greater than 50% improvement in physicians' overall response evaluations (p = 0.016). As estimated by patients, responses also showed significant improvement in the rIFN-γ group compared with the placebo group (53% vs 21%, p = 0.002). Significant reductions in erythema (p = 0.035) and in excoriations or erosions (p = 0.045) occurred in rIFN-γ-treated patients. Other atopic symptoms such as conjunctivitis (p <0.002) were also reduced in the rIFN-γ group. Occasional headaches, myalgias, or chills occurred in 30% to 60% of rIFN-γ-treated patients but were effectively prevented by pretreatment acetaminophen and by dosing at bedtime. Grade II granulocytopenia occurred in five rIFN-γ patients but normalized with continued treatment. Reduction to alternate-day dosing was necessary for six patients in the rIFN-γ group and two in the placebo group. Seven had mild elevations of hepatic transaminase levels that did not affect therapy. The mean eosinophil count was significantly reduced (p = 0.003), whereas a nonsignificant increase in serum IgE levels occurred in the active treatment group. Conclusion: This study demonstrated that rIFN-γ given by daily subcutaneous injection over a 12- week period was safe, well accepted, and effective in reducing inflammation, clinical symptoms, and eosinophilia in severe atopic dermatitis.

Original languageEnglish (US)
Pages (from-to)189-197
Number of pages9
JournalJournal of the American Academy of Dermatology
Volume28
Issue number2 I
StatePublished - 1993

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Atopic Dermatitis
Interferon-gamma
Placebos
Therapeutics
Subcutaneous Injections
Physicians
Chills
Agranulocytosis
Conjunctivitis
Body Surface Area
Myalgia
Eosinophilia
Erythema
Acetaminophen
Transaminases
Double-Blind Method
Eosinophils
Immunoglobulin E
Multicenter Studies
Headache

ASJC Scopus subject areas

  • Dermatology

Cite this

Hanifin, J., Schneider, L. C., Leung, D. Y. M., Ellis, C. N., Jaffe, H. S., Izu, A. E., ... Cooper, K. D. (1993). Recombinant interferon gamma therapy for atopic dermatitis. Journal of the American Academy of Dermatology, 28(2 I), 189-197.

Recombinant interferon gamma therapy for atopic dermatitis. / Hanifin, Jon; Schneider, L. C.; Leung, D. Y M; Ellis, C. N.; Jaffe, H. S.; Izu, A. E.; Bucalo, L. R.; Hirabayashi, S. E.; Tofte, Susan; Cantu-Gonzales, G.; Milgrom, H.; Boguniewicz, M.; Cooper, K. D.

In: Journal of the American Academy of Dermatology, Vol. 28, No. 2 I, 1993, p. 189-197.

Research output: Contribution to journalArticle

Hanifin, J, Schneider, LC, Leung, DYM, Ellis, CN, Jaffe, HS, Izu, AE, Bucalo, LR, Hirabayashi, SE, Tofte, S, Cantu-Gonzales, G, Milgrom, H, Boguniewicz, M & Cooper, KD 1993, 'Recombinant interferon gamma therapy for atopic dermatitis', Journal of the American Academy of Dermatology, vol. 28, no. 2 I, pp. 189-197.
Hanifin J, Schneider LC, Leung DYM, Ellis CN, Jaffe HS, Izu AE et al. Recombinant interferon gamma therapy for atopic dermatitis. Journal of the American Academy of Dermatology. 1993;28(2 I):189-197.
Hanifin, Jon ; Schneider, L. C. ; Leung, D. Y M ; Ellis, C. N. ; Jaffe, H. S. ; Izu, A. E. ; Bucalo, L. R. ; Hirabayashi, S. E. ; Tofte, Susan ; Cantu-Gonzales, G. ; Milgrom, H. ; Boguniewicz, M. ; Cooper, K. D. / Recombinant interferon gamma therapy for atopic dermatitis. In: Journal of the American Academy of Dermatology. 1993 ; Vol. 28, No. 2 I. pp. 189-197.
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AU - Schneider, L. C.

AU - Leung, D. Y M

AU - Ellis, C. N.

AU - Jaffe, H. S.

AU - Izu, A. E.

AU - Bucalo, L. R.

AU - Hirabayashi, S. E.

AU - Tofte, Susan

AU - Cantu-Gonzales, G.

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N2 - Background: Atopic dermatitis is characterized by immunologic abnormalities including evidence for reduced interferon gamma production. Therapeutic options for treatment of atopic dermatitis are limited and unsatisfactory. Previous open trials have suggested efficacy for recombinant interferon-gamma (rIFN-γ) in treatment of severe atopic dermatitis. We describe the results of treatment with rIFN-γ, assessing clinical, immunologic, and laboratory safety parameters in 83 patients with moderate to severe atopic dermatitis. Objective: Our purpose was to determine in a randomized, placebo-controlled, double-blind multicenter study the effects of recombinant human interferon gamma therapy in patients with atopic dermatitis. Methods: Patients received 50 μg/m2 rIFN-γ (n = 40) or placebo (n = 43) by daily subcutaneous injection for 12 weeks. Seventy-eight patients completed the treatment course; two patients receiving rIFN-γ (one because of constitutional side effects) and three receiving placebo discontinued treatment before completion. Physician and patient overall response evaluations, clinical severity scores, body surface area involvement, and laboratory parameters were monitored throughout the trial. Results: Patients in both treatment groups were similar except that the rIFN-γ group was older and had a longer disease duration. Forty-five percent of rIFN-γ-treated patients and 21% of placebo-treated patients achieved greater than 50% improvement in physicians' overall response evaluations (p = 0.016). As estimated by patients, responses also showed significant improvement in the rIFN-γ group compared with the placebo group (53% vs 21%, p = 0.002). Significant reductions in erythema (p = 0.035) and in excoriations or erosions (p = 0.045) occurred in rIFN-γ-treated patients. Other atopic symptoms such as conjunctivitis (p <0.002) were also reduced in the rIFN-γ group. Occasional headaches, myalgias, or chills occurred in 30% to 60% of rIFN-γ-treated patients but were effectively prevented by pretreatment acetaminophen and by dosing at bedtime. Grade II granulocytopenia occurred in five rIFN-γ patients but normalized with continued treatment. Reduction to alternate-day dosing was necessary for six patients in the rIFN-γ group and two in the placebo group. Seven had mild elevations of hepatic transaminase levels that did not affect therapy. The mean eosinophil count was significantly reduced (p = 0.003), whereas a nonsignificant increase in serum IgE levels occurred in the active treatment group. Conclusion: This study demonstrated that rIFN-γ given by daily subcutaneous injection over a 12- week period was safe, well accepted, and effective in reducing inflammation, clinical symptoms, and eosinophilia in severe atopic dermatitis.

AB - Background: Atopic dermatitis is characterized by immunologic abnormalities including evidence for reduced interferon gamma production. Therapeutic options for treatment of atopic dermatitis are limited and unsatisfactory. Previous open trials have suggested efficacy for recombinant interferon-gamma (rIFN-γ) in treatment of severe atopic dermatitis. We describe the results of treatment with rIFN-γ, assessing clinical, immunologic, and laboratory safety parameters in 83 patients with moderate to severe atopic dermatitis. Objective: Our purpose was to determine in a randomized, placebo-controlled, double-blind multicenter study the effects of recombinant human interferon gamma therapy in patients with atopic dermatitis. Methods: Patients received 50 μg/m2 rIFN-γ (n = 40) or placebo (n = 43) by daily subcutaneous injection for 12 weeks. Seventy-eight patients completed the treatment course; two patients receiving rIFN-γ (one because of constitutional side effects) and three receiving placebo discontinued treatment before completion. Physician and patient overall response evaluations, clinical severity scores, body surface area involvement, and laboratory parameters were monitored throughout the trial. Results: Patients in both treatment groups were similar except that the rIFN-γ group was older and had a longer disease duration. Forty-five percent of rIFN-γ-treated patients and 21% of placebo-treated patients achieved greater than 50% improvement in physicians' overall response evaluations (p = 0.016). As estimated by patients, responses also showed significant improvement in the rIFN-γ group compared with the placebo group (53% vs 21%, p = 0.002). Significant reductions in erythema (p = 0.035) and in excoriations or erosions (p = 0.045) occurred in rIFN-γ-treated patients. Other atopic symptoms such as conjunctivitis (p <0.002) were also reduced in the rIFN-γ group. Occasional headaches, myalgias, or chills occurred in 30% to 60% of rIFN-γ-treated patients but were effectively prevented by pretreatment acetaminophen and by dosing at bedtime. Grade II granulocytopenia occurred in five rIFN-γ patients but normalized with continued treatment. Reduction to alternate-day dosing was necessary for six patients in the rIFN-γ group and two in the placebo group. Seven had mild elevations of hepatic transaminase levels that did not affect therapy. The mean eosinophil count was significantly reduced (p = 0.003), whereas a nonsignificant increase in serum IgE levels occurred in the active treatment group. Conclusion: This study demonstrated that rIFN-γ given by daily subcutaneous injection over a 12- week period was safe, well accepted, and effective in reducing inflammation, clinical symptoms, and eosinophilia in severe atopic dermatitis.

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