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Background  Long‐term management of moderate‐to‐severe psoriasis is usually discussed in terms of continuous administration; however, there are many situations in clinical practice where treatment may be withdrawn with subsequent retreatment.    Objective  To assess the clinical course after ixekizumab treatment withdrawal and retreatment, as well as the effectiveness of ixekizumab retreatment, in Japanese patients with plaque psoriasis.    Methods  This single‐arm, open‐label study ( UNCOVER ‐J; NCT01624233) comprised 78 patients with plaque psoriasis. After ixekizumab treatment (160‐mg loading dose, 80 mg every 2 weeks for the first 12 weeks, and then 80 mg every 4 weeks ( IXE  Q4W) until Week 52), 70 patients achieved a Psoriasis Area Severity Index ( PASI )75 response at Week 52. These 70 patients withdrew from ixekizumab treatment from Weeks 52 to 100. Patients who relapsed ( PASI  ≤50) during the Treatment Withdrawal Period were retreated with  IXE  Q4W for 192 weeks.    Results  At Weeks 52, 76 and 100,  PASI 75 response rates were 100%, 26% and 7%;  PASI 90 response rates were 87%, 11% and 3%; and  PASI 100 response rates were 53%, 0% and 0%. After treatment withdrawal, 87% of patients relapsed; median time to relapse was 143 days. After 12 weeks of retreatment with  IXE  Q4W, 83% of relapsed patients achieved  PASI 75, 68% achieved  PASI 90 and 25% achieved  PASI 100; improvements were maintained up to 120 weeks of retreatment. Treatment‐emergent adverse events and serious adverse events were reported in 56% and 4% of patients during the Treatment Withdrawal Period, and in 88% and 14% of patients during the Retreatment Period.    Conclusion  In patients withdrawn from ixekizumab after achieving  PASI 75, approximately half relapsed within 5 months of withdrawal; however, most patients recaptured response within 12 weeks, and response was maintained for up to 120 weeks of retreatment.

journal of the european academy of dermatology and venereology

Long‐term efficacy and safety results from an open‐label phase  III  study ( UNCOVER ‐J) in Japanese plaque psoriasis patients: impact of treatment withdrawal and retreatment of ixekizumab