PMID- 20098510
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211020
IS  - 1753-5174 (Print)
IS  - 1753-5174 (Electronic)
IS  - 1753-5174 (Linking)
VI  - 2
IP  - 4
DP  - 2009 Dec
TI  - Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, 
      Open-Label, Phase IIIb/IV Latin American Study Results.
PG  - 71-78
AB  - INTRODUCTION: Psoriasis is a debilitating, chronic inflammatory systemic disease 
      affecting around 2% of the South American population. Biological therapies offer 
      the possibility of long-term therapy with improved safety and efficacy. METHODS: 
      We conducted a multicentre, open-label, single-arm, Phase IIIb/IV study of adult 
      patients (18-75 years) with moderate-to-severe plaque psoriasis who were 
      candidates for systemic therapy or phototherapy. Patients received efalizumab 
      subcutaneously (1.0 mg/kg/wk). The primary endpoint was the proportion of 
      patients achieving a Physician Global Assessment (PGA) rating of "excellent" or 
      "cleared" at Week 24. Safety outcomes were adverse events (AEs), serious AEs 
      (SAEs) and abnormalities on laboratory tests. RESULTS: Of 189 patients included 
      in the intent-to-treat and safety populations, 104 (55.0%) were of Hispanic or 
      Latino ethnicity. At Week 24, 92/189 (48.7%) patients achieved or maintained a 
      PGA rating of "excellent" or "cleared". AEs were reported by 161/189 (85.2%) 
      patients, SAEs by 21/189 (11.1%). One patient died during the study 
      (meningoencephalitis). Laboratory findings were consistent with previous 
      experience. CONCLUSIONS: Efalizumab demonstrated sustained control of psoriasis 
      up to 24 weeks in patients from Latin America, confirming results seen in Phase 
      III studies conducted in North America and Europe.
FAU - Stengel, Fernando M
AU  - Stengel FM
FAU - Petri, Valeria
AU  - Petri V
FAU - Campbell, Gladys Am
AU  - Campbell GA
FAU - Dorantes, Gladys Leon
AU  - Dorantes GL
FAU - Lopez, Magdalina
AU  - Lopez M
FAU - Galimberti, Ricardo L
AU  - Galimberti RL
FAU - Valdez, Raul P
AU  - Valdez RP
FAU - de Arruda, Lucia F
AU  - de Arruda LF
FAU - Guerra, Mario Amaya
AU  - Guerra MA
FAU - Chouela, Edgardo N
AU  - Chouela EN
FAU - Licu, Daiana
AU  - Licu D
CN  - International IMP25161 Study Group
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Arch Drug Inf
JT  - Archives of drug information
JID - 101322852
PMC - PMC2805872
EDAT- 2010/01/26 06:00
MHDA- 2010/01/26 06:01
CRDT- 2010/01/26 06:00
PHST- 2010/01/26 06:00 [entrez]
PHST- 2010/01/26 06:00 [pubmed]
PHST- 2010/01/26 06:01 [medline]
AID - 10.1111/j.1753-5174.2009.00024.x [doi]
PST - ppublish
SO  - Arch Drug Inf. 2009 Dec;2(4):71-78. doi: 10.1111/j.1753-5174.2009.00024.x.