OBJECTIVES

The aim of this study was to evaluate the efficacy and safety of tofacitinib for the treatment of moderate to severe active psoriasis arthritis in adult patients who don’t responded or are intolerant to previous treatment with synthetic or biological disease-modifying drugs.

METHODS

A structured search was carried out in the Medline, Embase and Cochrane Review databases. The primary endpoint was American College of Rheumatology Response Criteria - ACR50, chosen because it is the most clinically relevant outcome. Study quality was assessed by Cochrane risk of bias tool - Rob 2. A cost-minimization analysis was performed, since studies of indirect comparison of tofacitinib with its comparators demonstrated similar effectiveness, and budget impact analysis.

RESULTS

Two phase III studies were selected: in the study with patients previously treated with anti-TNF, ACR50 in 3 months was 15% for placebo, 30% for 5mg tofacitinib (p = 0.003), and 28% for 10mg tofacitinib ( p = 0.007); in the study of patients previously treated with synthetic disease-modifying drugs in 3 months the response rates were 10% for placebo, 28% for tofacitinib 5mg and 40% for tofacitinib 10 mg (p <0.001 for both comparisons). Cost-minimization analysis: generated a cost saving that ranged from -USD 250.86 (in relation to Adalimumab) to -USD 2,803.86 (in relation to Imfliximabe). Budget impact: cost saving in one year was –USD 7,8 million, varying in the scenarios between –USD 1.7 million to –USD 12,03 million and in five years it was –USD 45,15 million varying in the scenarios between –USD 9,85 million to –US $ 69,83 million.

CONCLUSIONS

The few scientific evidence available, possibly due to the recent registration of this new indication with regulatory agencies, demonstrated that the drug has similar efficacy to biological disease-modifying drugs at a lower cost.