Photopheresis at onset of type 1 diabetes: a randomised, double blind, placebo controlled trial

Abstract

Background-In recent years photopheresis, an extracorporeal form of photochemotherapy using psoralen and ultraviolet A irradiation of leucocytes, has been claimed to be an eVective form of immunomodulation. Aim-To evaluate its eVect in type 1 diabetes we performed a double blind, controlled study using placebo tablets and sham pheresis in the control group. Methods-A total of 49 children, aged 10-18 years of age at diagnosis of type 1 diabetes were included; 40 fulfilled the study and were followed for three years (19 received active treatment with photopheresis and 21 placebo treatment). Results-The actively treated children secreted significantly more C peptide in urine during follow up than control children. C peptide values in serum showed corresponding diVerences between the two groups. The insulin dose/kg body weight needed to achieve satisfactory HbA1c values was always lower in the photopheresis group; there was no diVerence between the groups regarding HbA1c values during follow up. The treatment was well accepted except for nausea (n = 3) and urticaria (n = 1) in the actively treated group. There were no diVerences regarding weight or height, or episodes of infection between the two groups during follow up. Conclusion-Photopheresis does have an eVect in addition to its possible placebo eVect, shown as a weak but significant eVect on the disease process at the onset of type 1 diabetes, an eVect still noted after three years of follow up. (Arch Dis Child 2001;85:149-154)

The Immunological Effect of Photopheresis in Children with Newly Diagnosed Type 1 Diabetes

“…It has also been suggested that photopheresis is effective through dendritic-cell/T-cell interactions in stimulating T-cell responses or down-regulating a preexisting T-cell response (22,23). In a photopheresis trial of children with newly diagnosed type 1 diabetes, we noticed a moderate clinical effect with lower insulin requirement and slightly better residual insulin secretion in the treatment group (24). The double-blind, Calculation of relative quantification values.…”

Effect of Photopheresis on Lymphocyte Population in Children with Newly Diagnosed Type 1 Diabetes

“…In a double-blind, placebo-controlled (placebo tablets and sham pheresis) randomized study, we have shown that photopheresis has a weak but significant effect on the disease process at the onset of type 1 diabetes (28). The aim of the present study was to analyze if the effect of photopheresis is related to changes in the balance of lymphocyte populations, in particular, subsets of T cells.…”

Extended evaluation of the safety and efficacy of GAD treatment of children and adolescents with recent-onset type 1 diabetes: a randomised controlled trial

“…Residual insulin secretion facilitates metabolic control and decreases the risk of keto-acidosis [3], and even modest beta cell function, with stimulated C-peptide above 0.2 nmol/l, may reduce long-term complications [4]. Type 1 diabetes is an autoimmune disease [5]; however, most attempts to use immune intervention to preserve residual beta cell function have achieved limited benefits or have been associated with adverse effects [6][7][8][9][10][11][12][13][14][15][16][17][18][19]. Treatment with anti-CD3 monoclonal antibodies appears to be the most promising treatment to date, but several patients treated in this way, as well as with anti-CD20 monoclonal antibodies, have experienced treatment-related adverse events [20,21].…”