[Clinical evaluation and radiological observation of recombinant human tumor necrosis factor receptor-Fc fusion protein in treatment of active ankylosing spondylitis].

OBJECTIVE

To evaluate the efficacy of recombinant human tumor necrosis factor receptor-Fc fusion protein (rh TNFR:Fc) in the treatment of active ankylosing spondylitis (AS).

METHODS

68 patients with active AS underwent subcutaneous injection of rh TNFR: Fc 25 mg twice a week for 24 weeks. The following indexes were observed: improvement of at least 20% of reported symptoms, based on the multicomponent Assessments in AS (ASAS) response criteria (ASAS 20) at weeks 2, 6, 12 and 24, ASAS 50 and ASAS 70 responses, and improved scores on individual components of ASAS, including Bath AS disease activity index (BASDAI), acute phase reactants, and Bath AS metrology index (BASMI). And the X-ray images of patient's pelvis at weeks 0, 12, and 24 were graded based on BASRI.

RESULTS

After treatment of rh TNFR:Fc the primary and secondary efficacy end points of the 68 patients were all improved compared with the baseline values. During the process of treatment, the number of patients with the efficacy achieving ASAS20 was gradually rising: 44 cases (64.7%) at week 12 and 58 (85.0%) at week 24. The efficacy of 41 cases (60.3% ) reached ASAS50 and that of 34 cases reached ASAS70 at week 24. Other efficacy end points also reflected the similar effect and were improved significantly compared with the baseline values at different time points ( all P < 0.01). BASRI showed that the radiological improvement of sacroiliac joint was not significant (P > 0.05) and that the radiological improvement of hip was not obvious at week 12 (P > 0.05) but significant at week 24 (P < 0.05).

CONCLUSION

rh TNFR:Fc rapidly improves the signs and symptoms of active AS.