Introduction:

Currently, the induction of immune tolerance as a therapeutic approach in rheumatoid arthritis is an interesting focus of research. The results of the Phase I Clinical Trial Safety and pharmacokinetics of CIGB-814 in patients with rheumatoid arthritis, indicated preliminary evidence of clinical efficacy.

Objective:

To describe the clinical characteristics of patients treated with the therapeutic candidate CIGB-814, Jusvinza after the conclusion of the clinical trial

Method:

A descriptive, observational study of patients with rheumatoid arthritis treated with the CIGB 814 was carried out, at 12 and 24 months after the end of the clinical trial, during the period from September 2016 to June 2018, at the Reference Center for Rheumatic Diseases (Surgical Clinical Teaching Hospital October 10th). This study included 17 patients. The information of the quantitative variables was summarized by their absolute number and percentage. For the analysis and interpretation of the results, the percentage analysis was used.

Result:

The clinical evaluation by DAS 28 indicated that the patients fell into remission and they had functional disability mild. 64.7% of the patients remain in sustained remission after 12 months of concluded the clinical trial. In the final evaluation, 82.30 % expressed 70 % improvement (ACR 70) and 88.2 % with a good EULAR response. 70.60 % of patients are without functional disability. (HAQCU=0)

Conclusion:

At 12 and 24 months, patients maintained the clinical improvement achieved during the period of clinical trial, with an increase of improvement in the functional capacity. In addition, a reduction in the consumption of NSAIDs, steroids and methotrexate for the control of the disease was observed in all patients.

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