Remission Duration and Long-Term Outcomes in Patients with Moderate-to-Severe Psoriasis Treated by Biologics or Tofacitinib in Controlled Clinical Trials: A 15-Year Single-Center Experience

Abstract

INTRODUCTION: Relapse is common after treatment discontinuation for patients with moderate-to-severe psoriasis. The objective of this study was to understand the remission duration and long-term outcomes in psoriasis patients after biologic withdrawal. METHODS: We retrospectively included the follow-up data of 184 patients with moderate-to-severe psoriasis after the end of 11 biologic or tofacitinib trials conducted between 2004 and 2016. RESULTS: Among the 232 treatment courses, 95 achieved (psoriasis area and severity index) PASI 75 at the end of the studies. At 6 months after treatment discontinuation, the systemic treatment-free rates of our patients who entered the PRESTA, PRISTINE, PEARL, ERASURE, CLEAR, the global tofacitinib study, and the IXORA-P study were 66.7%, 66.7%, 75.0%, 16.7%, 22.2%, 33.3%, and 29.2%, respectively. Pooled data showed a serious adverse event incidence rate of 1.5/100 person-years. The proportions of systemic treatment-free episodes were 16.8%, 7.4%, 4.3%, 3.2%, and 3.2% at 1, 2, 3, 4, and 5 years, respectively. Biologics were reinitiated in 41.9%, 66.7%, 77.1%, 83.5%, and 86.1% at 1, 2, 3, 4, and 5 years, respectively. Multivariate generalized estimating equation (GEE) regression analysis demonstrated that predictors for a longer relapse-free duration were baseline PASI, PASI improvement, biologic naivety, and early biologic intervention. Patients who received early biologic intervention, who achieved PASI 90, and who were biologic naive showed significantly higher relapse-free rate by Kaplan-Meier analysis with log rank test. CONCLUSIONS: Systemic treatment was required in 86.1% of patients within 12 months after biologic withdrawal and biologics were reinitiated in 77.1% of patients after 3 years. However, early biologic administration within 2 years after diagnosis demonstrated a lower risk of relapse in patients with moderate-to-severe psoriasis.