Long-term outcomes of interruption and retreatment vs. continuous therapy with adalimumab for psoriasis: subanalysis of REVEAL and the open-label extension study.

BACKGROUND: REVEAL was a 52-week study of adalimumab for moderate to severe psoriasis. At Week 33, adalimumab-treated patients with sustained responses (PASI ≥75 at Weeks 16 and 33) were re-randomized to receive adalimumab or placebo. Subsequently, they could receive adalimumab in an open-label extension (OLE) study.

OBJECTIVE: To compare long-term efficacy and safety of adalimumab 40 mg every other week (eow), given as continuous treatment or with one period of interruption followed by retreatment.

METHODS: Patients who were re-randomized to adalimumab or placebo at REVEAL Week 33 and received ≥ 1 dose of OLE adalimumab were analysed as the continuous and retreatment groups, respectively, for >2 years of OLE treatment with adalimumab 40 mg eow. LOCF was used for missing efficacy data.

RESULTS: At OLE Weeks 0, 12 and 24, PASI 75 response rates were 84%, 84%, 86% with continuous treatment (N = 233) vs. 45%, 71%, 79% with retreatment (N = 227). Thereafter, efficacies were slightly greater for continuous treatment but similar between groups, with PASI 75 response rates at OLE Week 108 of 75% vs. 73% respectively. Retreatment was most effective for patients with ≥ PASI 50 responses when retreatment was initiated. Adverse event rates for retreatment were equal to or lower than those for continuous treatment.

CONCLUSIONS: In psoriasis patients with sustained PASI 75 responses to adalimumab, long-term efficacy of retreatment after a ≤ 19-week interruption was similar to efficacy achieved with > 3 years continuous treatment. Adalimumab retreatment provided the best results when initiated before responses had declined below PASI 50.