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Summary   Background  Tildrakizumab is a specific anti‐interleukin‐23p19 monoclonal antibody approved for the treatment of plaque psoriasis.    Objectives  To evaluate the long‐term efficacy and safety of tildrakizumab treatment for patients with moderate‐to‐severe psoriasis for up to 148 weeks.    Methods  Pooled analysis from two double‐blind, randomized controlled trials: re SURFACE  1 and re SURFACE  2. Efficacy was assessed for responders (≥ 75% improvement in Psoriasis Area and Severity Index;  PASI  75) and partial responders ( PASI  50–75) to tildrakizumab 100 mg and 200 mg at week 28 who were maintained on the same dose (administered every 12 weeks), and for partial responders or nonresponders ( PASI  < 50) to etanercept 50 mg at week 28 who, after a 4‐week washout, were switched to tildrakizumab 200 mg (administered at weeks 32 and 36, and every 12 weeks thereafter). Safety was assessed in the all‐patients‐as‐treated population. Three different methods of imputing missing data were used: nonresponder imputation ( NRI ), multiple imputation and observed cases. The Clinicaltrials.gov numbers are  NCT 01722331 (re SURFACE  1) and  NCT 01729754 (re SURFACE  2).    Results  At week 148 ( NRI ), 72·6%, 53·8% and 28·9% of tildrakizumab 100‐mg responders and 80·2%, 59·9% and 32·6% of tildrakizumab 200‐mg responders had  PASI  75, 90 and 100 responses, respectively. For partial responders to tildrakizumab 100 mg and 200 mg, the proportions of patients achieving  PASI  75, 90 and 100 responses were 32·5%, 25·0% and 10·0%; and 47·1%, 27·5% and 12·8%, respectively. For patients who were partial responders or nonresponders to etanercept, the proportions of patients achieving  PASI  75, 90 and 100 responses were 66·9%, 43·8% and 14·9% at week 148. Rates of discontinuations due to adverse events [tildrakizumab 100 mg: 1·7 per 100 patient‐years ( PY s); tildrakizumab 200 mg: 1·2 per 100  PY s] and exposure‐adjusted rates of serious adverse events (5·9 per 100  PY s; 5·5 per 100  PY s), severe infections (1·1 per 100  PY s; 1·1 per 100  PY s), malignancies (0·6 per 100  PY s; 0·4 per 100  PY s) and major adverse cardiovascular events (0·4 per 100  PY s; 0·5 per 100  PY s) were low.    Conclusions  Tildrakizumab was well tolerated and efficacy was well maintained in week 28 responders who continued tildrakizumab treatment through 3 years, or improved among etanercept partial responders or nonresponders who switched to tildrakizumab.What's already known about this topic?Tildrakizumab 100 mg and 200 mg are efficacious and well tolerated with short‐term use in the treatment of patients with moderate‐to‐severe plaque psoriasis.What does this study add?High levels of efficacy are maintained for up to 3 years of psoriasis treatment with tildrakizumab.  There is a favourable long‐term safety profile with both tildrakizumab 100 mg and 200 mg, with a low incidence of adverse events of special interest through 3 years.

british journal of dermatology

Long‐term efficacy and safety of tildrakizumab for moderate‐to‐severe psoriasis: pooled analyses of two randomized phase  III  clinical trials (re SURFACE  1 and re SURFACE  2) through 148 weeks