What happened after the clinical trials: long-term safety and efficacy of ustekinumab in daily clinical practice.
BACKGROUND
Ustekinumab has been investigated in patients with psoriasis by randomized clinical trials. There are few data on ustekinumab use under 'real life' conditions outside long-term registries.


OBJECTIVE
The aim of our study was to evaluate the efficacy and safety of ustekinumab as a long-term therapy in real life.


METHODS
We retrospectively analyzed the data of 71 patients who had been treated with ustekinumab up to 2 years. Efficacy data were analyzed both by 'as treated' and 'intention to treat-last observation carried forward'.


RESULTS
A significant improvement in the Psoriasis Area and Severity Index score was observed at 4 weeks and further improvements were observed throughout the treatment. Adverse events were generally mild.


CONCLUSIONS
In routine administration ustekinumab seems to be more efficient than reported by randomized clinical trials. Our results are encouraging and can answer the patients' biggest concern on whether ustekinumab is an effective and safe drug for long-term use.
Department of Dermatology, University of Rome 'Tor Vergata', Rome, Italy.
Marina
M
Talamonti
Marco
M
Galluzzo
Luca
L
Bianchi
Andreea N
AN
Boca
Antonio
A
Costanzo
Sergio
S
Chimenti
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D000069549:Ustekinumab; D055815:Young Adult
D000894:Anti-Inflammatory Agents, Non-Steroidal; D061067:Antibodies, Monoclonal, Humanized; D000069549:Ustekinumab