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Thymopentin Treatment in Severe Atopic Dermatitis-Clinical and Immunological Evaluations

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Thymopentin Treatment in Severe Atopic Dermatitis-Clinical and Immunological Evaluations Archives ofDisease in Childhood 1992; 67: 1095-1102 1095 Arch Dis Child: first published as 10.1136/adc.67.9.1095 on 1 September 1992. Downloaded from Thymopentin treatment in severe atopic dermatitis-clinical and immunological evaluations Kue-Hsiung Hsieh, Men-Fang Shaio, Tung-Nan Liao Abstract remains unclear, a number of immunological An open clinical trial of thymopentin was abnormalities have been described. They conducted on 16 children with severe atopic include: dermatitis. The patients were treated with (i) Raised and sustained serum IgE injections three times a week of 50 mg thymo- concentrations,8 pentin for six weeks. They were then divided (ii) Impaired T cell function,9 randomly into two groups: group A continued (iii) Decreased natural killer cell activity,'0 thymopentin for an additional six weeks, and (iv) Defective capacity to generate alloreactive group B were treated with normal saline. cytotoxic T cells," Clinical parameters and immunological func- (v) Impaired autologous mixed lymphocyte tion were evaluated serially. The total severity reaction due to defective CD4 responder score started to decline from baseline signifi- T cells'2 cantly three weeks after treatment, and con- (vi) Increased cell mediated cytotoxicity tinued throughout the study period in group A against skin fibroblasts,'3 but began to flare up in group B two weeks (vii) Most importantly, immunological recon- after stopping thymopentin. AlU the eight stitution after bone marrow transplantation patients in group A completed the trial but results in the permanent resolution of eczema in three out of eight in group B dropped out Wiskott-Aldrich syndrome, a primary T cell because of flaring up of skin lesion. In vitro immunodeficiency with raised serum IgE, production of interleukin-4 tended to decrease providing in vivo evidence that immune defects and that of interferon gamma tended to predispose to the development of eczema. 14 increase, but total serum IgE, in vitro IgE Thymopoietin is a polypeptide hormone of synthesis, and abnormaliy low CD8+ the thymus, originally isolated from bovine CD11b+ suppressor T cells remained thymus extract by its effect on neuromuscular unchanged. Histamine releasing factor transmission. 5 It is secreted by thymic epithelial (HRF), plasma histamine, and respiratory cells and has been shown to influence both the burst activities of polymorphonuclear leuco- differentiation of thymocytes'6 and the function http://adc.bmj.com/ cytes were appreciably decreased after of mature T cells. 17 18 Thymopentin (Timunox, thymopentin treatment. Immunobiology Research Institute, Annandale, It is concluded that the clinical efficacy of NJ) is the active pentapeptide (Arg-Lys-Asp- short term thymopentin treatment very Val-Tyr) moiety corresponding to amino acids possibly results from the decreased production 32 to 36 of the linear 49 amino acid sequence of of HRF and decreased release of polymorpho- thymopoietin. The biological effects of thymo- nuclear leucocyte derived inflammatory pentin mimic those of thymopoietin in all on September 27, 2021 by guest. Protected copyright. mediators and may have no relation with systems in which it has been evaluated.'8 19 It antigen-IgE immune reaction. was marketed in Italy in 1985, in Belgium in 1987, and in Germany in 1988, and has been used in a number of diseases in which T cell Department of (Arch Dis Child 1992;67:1095-102) Paediatrics, deficiency may have a role.20 National Taiwan Recent studies suggest that thymopentin University College Atopic dermatitis is a chronic cutaneous influences IgE synthesis,2' and it might therefore of Medicine inflammatory disease characterised by early age influence the course of atopic diseases in man. Kue-Hsiung Hsieh Tung-Nan Liao of onset, severe pruritus, typical morphology Recently, clinical improvement with thymo- Department of and distribution of skin rash, chronic relapsing pentin that produced reductions in overall Parasitology and course, and personal or family history ofatopy. ' 2 severity in patients with atopic dermatitis has Tropical Medicine, It is a common disease among infants and been reported,22 23 but the working mechanisms National Defense Medical Center, children with an incidence of 1-9% to 8-3% in have not been studied extensively. We present Taipei, white people"6 and 1 24% in Chinese school- the clinical efficacy of an open trial of thymo- Taiwan, children.7 Chronic atopic dermatitis may result pentin in children with severe atopic dermatitis Republic of China in significant morbidity, including hospital- and correlate the clinical efficacy with the in Men-Fang Shaio isation for control of skin disease and infection, vivo and in vitro immunological changes after Correspondence to: Dr Kue-Hsiung Hsieh, lost school days, psychological trauma from thymopentin treatment. Department of Paediatrics, physical disfigurement, and occupational National Taiwan University Hospital, disability. The management of atopic dermatitis 7 Chung-Shan S Road, has been less than satisfactory. None of the Subjects and methods Taipei, 10016, Taiwan, currently available treatments are curative and SUBJECTS Republic of China. treatment is empirical.6 Sixteen children, nine boys and seven girls, Accepted 26 February 1992 Although the pathogenesis ofatopic dermatitis aged 3 to 14 years, were enrolled into this study. 1096 Hsieh, Shaio, Liao The clinical trial was approved by the human Table I Monoclonal antibodies used to enumerate Arch Dis Child: first published as 10.1136/adc.67.9.1095 on 1 September 1992. Downloaded from research committee ofthis hospital and informed lymphocyte subpopulations consent was obtained for each patient. All of the CD3 (total T cells) patients had severe pruritus, skin lesions of CD19 (total B cells) CD3 -CD 16+CD56+ (natural killer cells) characteristic morphology and distribution, CD4 (helper/inducer) chronic relapsing course, and a history of atopy, CD4+CD45RA+ (suppressor/inducer) CD4+CD45R- (helper/inducer) which met the criteria for the diagnosis of atopic CD8+ (suppressor/cytotoxic) dermatitis.' 2 The age of onset ranged from CD8+CDllb+ (suppressor) CD8+CDIIb- (cytotoxic) 1 month to 1 year, the mean (SD) duration of CD3+CD25 + (activated CD3) atopic dermatitis was 8-6 (3 0) years, the serum CD4+CD25 + (activated CD4) CD8 +CD25 + (activated CD8) IgE concentrations ranged from 224 to 5241 IU/ CD3+HLA-DR+ (activated CD3) ml (mean (SD) 2318 (1525) IU/ml), and the CD4+HLA-DR+ (activated CD4) mean (SD) area of involved body surface was CD8+HLA-DR+ (activated CD8) 81-5 (25 0)%. The severity was graded on a scale of 0-3 for each of the five parameters: erythema, pruritus, oedema/papulation, ex- coriation, and scaling/dryness. To be enrolled tion of 2 x 106 cells/ml in complete culture the patient had to have a severity score of 6 or medium (Roswell Park Memorial Institute-1640 higher (including a score of 2 or more for both supplemented with 10% heat inactivated fetal erythema and pruritus). The mean (SD) total calf serum, antibiotics and L glutamine) were severity score before treatment was 14-4 (0 9) stimulated with 2 [tg/ml phytohaemagglutinin (range 12-15). Twenty healthy schoolchildren, (PHA) (Wellcome) for three days and the aged 7 to 15 years, were included as controls for supernatants were collected by centrifugation immunological study. and stored at -20°C until testing.24 25 The above mentioned culture conditions, including cell density, PHA concentration, and days of TREATMENT PROTOCOL cultivation, were found to be optimal for After enrolment the patients received three sub- cytokine production in our previous studies.2F26 cutaneous injections each week of 50 mg of thymopentin for a consecutive six weeks. The patients were then divided randomly into two Measurements ofsoluble interleukin (IL)-2R, CD4 groups. One group (group A) continued the molecule, and cytokines in supernatants thymopentin treatment for an additional six Cell free CD4 and IL-2 receptor tests kits were weeks, and the other group (group B) was purchased from T Cell Sciences (Cambridge, injected with normal saline. Both groups were MA), IL-2 and interferon gamma test kits from comparable regarding age, severity score, and Genzyme (Boston, MA), and IL-4 and IL-6 test serum IgE concentration. During the treatment kits from R and D System (Minneapolis, MN). patients were allowed to continue antihista- The principle of those tests was sandwich mines and topical corticosteroids, but systemic enzyme immunoassay (ELISA), using two http://adc.bmj.com/ corticosteroids were discontinued for at least monoclonal antibodies against different epitopes four weeks before the study. No recommenda- of the target molecule (CD4, IL-2, and IL-2R) tion on food restriction and environmental con- or monoclonal antibody (first) followed by poly- trol was made. clonal antibody (IL-4, IL-6, and interferon gamma). The sensitivity of the ELISA was 50 pg/ml for IL-2, 50 U/ml for IL-2R, 12 U/ml for CD4, 3 pg/ml for IL-4, 3 5 pg/ml for IL-6, and on September 27, 2021 by guest. Protected copyright. EVALUATION 100 for interferon The patients were seen every week by one pg/ml gamma. The interassay variation of all tests were around 5-10% and a author (KHH). Dermatological assessment, similar routine laboratory tests (blood chemistry, hae- figure was found for intra-assay. All the matology, and urinalysis), and immunological samples of a single individual were run in tests were performed before and at the end of duplicate simultaneously and at least one the third, sixth, and 12th week after treatment. normal control was included in each experiment. The clinical response was evaluated by a derma- tologist who did not know the treatment pro- tocol, and adverse reactions were observed Measurement of histamine releasing factor (HRF) carefully. Parents' satisfaction was recorded. activity HRF was measured as previously described.27 MNCs (2 x 106 cells/ml) were stimulated with 2 [ig/ml PHA for four hours, washed, and IMMUNOLOGICAL TESTS incubated for additional 20 hours.
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