Objectives to describe the long-term efficacy and types of adverse events (AEs) in psoriatic arthritis (PsA) patients treated with etanercept in a daily clinical setting in Belgium.
Methods This is a prospective, multi-center, open-label, observational study in patients with active PsA, who have previously failed DMARD therapy. Patients were treated with etanercept 25 mg subcutaneously twice a week or 50 mg OW. Health Assessment Questionnaire (HAQ-DI) was completed, swollen joint count was made, and adverse events (AEs) occurring during the treatment period were registered. Patients were followed up for 5.5 years.
Results 303 patients were treated with etanercept, representing a total of 1184 patient-years. 114 patients discontinued treatment, and 33 patients were lost to follow-up. Reasons for discontinuation included non-responder (primary and secondary, n =54) and safety (n = 31). 204 (67,77%) patients reported adverse events of which 177(58,8%) events were related to the treatment. 65(21,59%) patients reported a serious adverse event of which 53 (17,61%) events are considered to be related to the treatment. Infections were the most frequent AE’s. 13 cases were considered as serious adverse events. No cases of tuberculosis were reported. 6 cases of herpes zoster were noticed. Injection site reactions were uncommon (n=6). Efficacy was evaluated by measuring number of joints with active synovitis and HAQ-DI. At baseline, the mean number of joints with active synovitis was 11,81±6,77. At month 6, the mean number of joints with active synovitis decreased to 2,1 ± 3,36. At month 66, the mean number of joints with synovitis further decreased to 0,73 ± 2,00. This represents a statistically significant decrease at both time points from baseline. 118 out of 152 (77,63%) patients with presented with no swollen joints at month 66. At baseline, the mean HAQ-DI-score (/60) was 26,99±8,94. At month 6, the mean HAQ- DI score decreased to 9,72± 9,37. At month 66, the HAQ-DI-score was 7,70± 9,09. This represents a statistically significant decrease at both time points from baseline.
Conclusions These results confirm the safety and efficacy profile of Enbrel in psoriatic arthritis when used in daily clinical practice in Belgium. No new safety signals were detected.
Disclosure of Interest K. de Vlam Consultant for: Pfizer, Speakers bureau: Pfizer, C. Boone Employee of: Pfizer