3PC-040 Oral suspension of dapsone 2 mg/ml. efficacy, safety and formulation in paediatric patient with linear Ig A dermatosis: a case report

<h3>Background and Importance</h3> Linear Ig A dermatosis of childhood is a rare autoimmune disorder, which manifests with outbreaks of vesicular and bullous lesions. The first-line treatment is dapsone. <h3>Aim and Objectives</h3> To evaluate the efficacy and safety of treatment with mastered formula (FM) of dapsone 2 mg/ml oral suspension in a child with linear Ig A dermatosis. Describe the preparation of the FM. <h3>Material and Methods</h3> Retrospective observational study of a child with linear Ig A dermatosis treated with dapsone. The variables collected: sex, age, analytical data (blood count, reticulocytes, glucose 6-phosphate dehydrogenase (G6PD) deficiency test, kidney and liver function), previous treatments and data related to treatment with dapsone. (concentration, dose, frequency of administration, duration of treatment, efficacy and safety). The clinical history and FM preparation protocols were reviewed. <h3>Results</h3> 23-month-old patient with blistering lesions in different locations. Skin biopsy compatible with linear Ig A dermatosis confirmed with direct immunofluorescence test. Previously treated with oral prednisone. He has normal G6PD activity and a normal blood count, and oral dapsone 1.5 mg/kg/day is started. A bibliographic search was carried out, finding an oral suspension preparation from dapsone tablets and SyrSpend SF PH4, with physicochemical stability of 90 days at room temperature and in the refrigerator. A microbiological risk matrix was applied, assigning a validity period of 90 days in the refrigerator and 30 days at room temperature. From the beginning, a favourable evolution was observed, with rapid resolution of injuries. Five months after starting treatment, he had an outbreak with perioral lesions, increasing the dose of dapsone to 2 mg/kg/day. Two months later, in a control analysis, haemoglobin values of 9.5 g/dl and MCV of 87.9 fL were observed, diagnosing megaloblastic anaemia secondary to the medication. Treatment is temporarily suspended, with analytical values normalising after 40 days. It was decided to treat again with dapsone 0.5 g/kg/day. Currently the patient has no active lesions and no significant analytical abnormalities. <h3>Conclusion and Relevance</h3> FM dapsone 2 mg/ml oral suspension was found to be effective for the treatment of linear Ig A dermatosis with excellent short-term response and prolonged remissions. Regarding safety, periodic analytical controls are recommended to avoid the appearance of megaloblastic anaemia. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest