Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: results of an open-label, single-arm pilot study.
BACKGROUND
No clinical trial of efalizumab has been conducted in Asia.


OBJECTIVE
To determine the efficacy and safety of efalizumab in Taiwanese patients with psoriasis.


METHODS
This is an open-label, single-arm pilot study conducted at two centres. Patients were given 1 mg/kg efalizumab subcutaneously once a week for 12 weeks and were then followed up for a further 12 weeks.


RESULTS
A total of 49 patients participated in the study. The median improvement in Psoriasis Area and Severity Index (PASI) during the treatment period was 19.6%, and a >or= 50% improvement in PASI was seen in 20.4%. Rebound was seen in 17.8% of patients, and anti-efalizumab antibodies were detected in 41% of patients. The most frequent adverse events were headache (34.7%), arthralgia/arthritis (28.6%), psoriasis events (new form/exacerbation; 26.5%) and pruritus (22.4%).


CONCLUSIONS
This small pilot study indicated that efalizumab was effective in improving psoriasis symptoms in Taiwanese patients, with no new safety issues identified.
Tsai
T F
TF
The Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan. tftsai@yahoo.com
Liu
M T
MT
Liao
Y H
YH
Licu
D
D
D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D004305:Dose-Response Relationship, Drug; D004361:Drug Tolerance; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D013624:Taiwan; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C472181:efalizumab