Efficacy and safety of continuous versus paused etanercept treatment in patients with moderate-to-severe psoriasis over 54 weeks: the CRYSTEL study

Objective: To evaluate the efficacy and safety of continuous and paused etanercept regimens in psoriasis patients. Methods: Patients with moderate-to-severe plaque psoriasis were randomized to receive continuous etanercept 25 mg twice weekly or paused etanercept for 54 weeks. The paused group received etanercept 50 mg twice weekly for no more than 12 weeks until reaching a Physician Global Assessment (PGA) of 2 or less (mild or better), when treatment was paused; upon relapse (PGA ≥ 3), etanercept was resumed at 25 mg twice weekly until a PGA of 2 or less was regained. The primary efficacy end point was mean PGA over 54 weeks, which was compared between the continuous and paused groups. Secondary efficacy end points included changes from baseline in mean PGA score, Psoriasis Area and Severity Index (PASI) and patient satisfaction with current psoriasis treatment. Results: Among 711 patients evaluable for efficacy, the mean PGA score averaged over 54 weeks (primary end point) was significantly lower in the continuous etanercept therapy group than in the paused etanercept therapy group (1.98 vs 2.51, respectively; p < 0.001). Mean PGA was significantly reduced from baseline (3.6, both groups) to week 54 in the continuous (1.9) and paused groups (2.4; p < 0.01, within-group comparisons). Mean PASI was significantly decreased from baseline (21.9 and 22.8, respectively) to week 54 with continuous (7.1) and paused therapy (9.5; p < 0.01, within-group comparisons). PASI improved by 68 and 59% from baseline to week 54 in patients receiving continuous and paused etanercept, respectively. Patient satisfaction rates improved from 20.2 and 22.5% in continuous and paused groups, respectively, at baseline to 83.5 and 83.0% at week 12; 83.3 and 78.3% at week 24; and 81.3 and 72.6% at week 54, respectively. Overall, 7.5% (54 out of 720) of patients had serious adverse events (6.4 and 8.5%, continuous and paused groups, respectively); four patients (two per group) had serious infections. No cases of tuberculosis or demyelinating diseases were observed. Conclusion: Both continuous and paused etanercept therapies improved PGA and PASI scores and patient satisfaction rates; patients receiving continuous etanercept therapy showed a greater level of improvement, although those who paused and resumed active treatment generally recaptured response and experienced sustained benefit.