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Clinical pharmacy and clinical trials (including case series)
Evaluation of tocilizumab in two off-label inflammatory processes refractory to other approved treatments
  1. C. Dávila Fajardo,
  2. C. Medarde,
  3. C. Ruiz
  1. 1Hospital Universitario San Cecilio Farmacia Hospitalaria Granada, Spain


Background Tocilizumab is a monoclonal antibody for human use, capable of neutralising the biological effect of IL-6 by blocking its specific receptor IL-6R; it has proven effective in the treatment of rheumatoid arthritis (RA). There are a few published cases in off-label amyloidosis and SLE (systemic lupus erythematosus).

Purpose To find out whether tocilizumab got good results in two individuals with off-label inflammatory processes refractory to other approved treatment.

Materials and methods A Senegalese patient aged 27 was diagnosed with nephrotic syndrome secondary to renal amyloidosis. No possible cause except a history of having had tuberculosis (Mantoux +, negative Lowenstein). Prophylactic treatment was started with rifampicin/isoniazid but given the poor prognosis treatment with tocilizumab 8 mg /kg was initiated monthly and the response assessed. A patient 28 years of age was diagnosed with systemic lupus erythematosus 2 years ago. At the onset of the disease several treatments were used with corticosteroids, mycophenolate and cyclophosphamide. Since the disease was progressing it was decided to introduce rituximab treatment with little response, the patient even had an allergic reaction and the treatment was stopped. The patient suffered clinical and laboratory deterioration with recurrence of systemic symptoms (fever, rash, polyarthritis and increased acute phase reactions). It was decided to initiate treatment with tocilizumab (off label) (8 mg / kg=160 mg) every 2 weeks.

Results After the first dose, the amyloidosis patient showed a good response with decreased proteinuria and improved creatinine clearance, but the proteinuria deteriorated again after the second dose. Tocilizumab was stopped. In the SLE patient, after the third dose an insufficient respond was obtained and the dose was increased to 240 mg. At the time of writing the patient had received 7 doses of tocilizumab in combination with corticosteroids and the symptoms of the disease were controlled.

Conclusions Tocilizumab was not able to control the effects of amyloidosis but it was able to control those of SLE in another patient.

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