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Drug information and pharmacotherapy
DI-055 Evaluation of tocilizumab response in rheumatoid arthritis. Comparision of the results with the clinical trial
  1. MDC Gonzalez Medina1,
  2. C Davila Fajardo1,
  3. X Diaz Villamarin1,
  4. MJ Soto Pino1,
  5. LJ Martinez2,
  6. D Blanquez Martinez1,
  7. M Valle Corpas1,
  8. E Raya Alvarez3,
  9. R Moron Romero1,
  10. J Cabeza Barrera1
  1. 1Department of Clinical Pharmacy Instituto de Investigación Biosanitaria de Granada Hospital Universitario San Cecilio, Pharmacy, Granada, Spain
  2. 2Genomics Unit Centre for Genomics and Oncological Research GENYO- Pfizer-University of Granada-Andalusian Regional Government, Pharmacy, Granada, Spain
  3. 3Hospital Universitario San Cecilio, Rheumatology, Granada, Spain

Abstract

Background Tocilizumab (TCZ) is a humanised monoclonal antibody inhibitor of interleukin 6 receptor, indicated in combination with methotrexate in the treatment of rheumatoid arthritis (RA) in patients with inadequate response or intolerance to prior therapy.

Purpose The goal of this study was to compare the efficacy of TCZ obtained in our study with that obtained in a clinical trial.

Material and methods Descriptive observational study of all patients diagnosed with RA and treated with TCZ from March 2009 until January 2015. Demographic data were collected by reviewing the medical records of patients: age, sex, race, weight, height, rheumatoid factor (RF) and erosions, and prior and concomitant therapy.

DAS28 is a measure of disease activity in RA, referring to the 28 joints that are examined in this assessment. DAS28 at baseline and 24 weeks for each patient were calculated, and the following were assessed based on the EULAR criteria: remission, DAS28 <2.6, good response, DAS28 <3.2 and change in DAS28 >1.2, moderate response, DAS28 > 3.2 and change in DAS28 between 0.6–1.2.

Results 176 patients with the following characteristics were included: 79% female, mean age 53,25 years (±12.42), weight 72.85 kg (±13,75) and average height 157 cm (±7.27). 66 patients were RF positive and 125 had erosions. 94.9% of patients were taking DMARD previously (89.2% ​​of patients were treated with methotrexate, 59.1% with leflunomide, 23.3% with sulfasalazine), with an average number of previous DMARD of 1.88. 29% had no prior biological treatment. Concomitant therapy: 56.8% of patients were treated with DMARD; 52.3% ​​of patients were treated with methotrexate; 6.3% with leflunomide; 5.1% with sulfasalazine; and the rest had no concomitant DMARD. Mean DAS28 at baseline was 5.71 (±1.13) and DAS28 at 24 weeks was 2.90 (±1.24). The mean difference between DAS28 at baseline and at 24 weeks was 2.6906. According to the EULAR criteria, a good response was achieved in 49.4% patients, moderate response in 5.7% and remission in 36,9%.

In the clinical trial, the results were: 38% good response, 41% moderate response and 27% remission.

Conclusion In our study, TCZ has shown a comparable response with that in the clinical trial; efficacy was higher, as were rates for good response and remission.

No conflict of interest.

http://dx.doi.org/10.1136/ejhpharm-2016-000875.321

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