Efalizumab treatment of psoriasis vulgaris: a cohort study in outpatient clinical practice.
BACKGROUND
Efalizumab is approved by the European Medicines Evaluation Agency for the treatment of adult patients with moderate to severe plaque psoriasis who fail to respond to, have a contraindication for, or cannot tolerate other systemic therapies.


OBJECTIVE
To evaluate the efficacy and safety of efalizumab treatment in daily practice at a dermatology department in a teaching hospital in Barcelona, Spain.


METHODS
A cohort study was carried out for patients treated with efalizumab for at least 3 months between May 2005 and July 2007. In total, 31 patients [21 men, 10 women; mean psoriasis and severity index (PASI) 12.9] were treated with efalizumab. Data were collected prospectively, including PASI, and recorded at the start of treatment and at follow-up visits with a frequency of at least every 3 months.


RESULTS
At the end of the study period, efalizumab treatment was ongoing in 18 of the 31 patients (58.1%), and 7 of these patients had been treated for > or = 24 months. At week 12, 67.7% of the patients treated with efalizumab had achieved an improvement of 50% in PASI (PASI 50), 41.9% reached PASI 75, and 16.1% reached PASI 90 (intention to treat and as-treated analyses). In all, 19 patients (61.3%) received treatment for > or = 24 weeks. At week 24, 89.5% of these patients reached PASI 75, and 26.3% reached PASI 90 (as-treated analysis). During efalizumab treatment, mainly mild adverse effects were reported, including transient papular or circinate exacerbations of psoriasis, which were seen in five patients (16.1%). Rebounds (defined as PASI > or = 125% of baseline, leading to erythroderma in two patients) occurred in 7/31 patients (22.6%); this occurred while on treatment in 5/11 nonresponding patients (45.5%) and after discontinuation of treatment in 2/20 patients with good response (10.0%).


CONCLUSIONS
Efalizumab is an effective and safe treatment for psoriasis in most patients of a high need population in routine practice, and provides maintained improvement in 'responders'. Combination treatment was transiently used in 48.4% of patients to optimize therapeutic results. Special consideration must be given to possible rebound in patients with an inadequate response or after discontinuation of treatment.
Puig
L
L
Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Catalonia, Spain. lpuig@santpau.cat
Roé
E
E
García-Navarro
X
X
Corella
F
F
Alomar
A
A
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D004334:Drug Administration Schedule; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; C472181:efalizumab