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Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results.

Stengel FM, Petri V, Campbell GA, Dorantes GL, López M, Galimberti RL, Valdez RP, de Arruda LF, Guerra MA, Chouela EN, Licu D - Arch Drug Inf (2009)

Bottom Line: Biological therapies offer the possibility of long-term therapy with improved safety and efficacy.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.

View Article: PubMed Central - PubMed

ABSTRACT
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.

No MeSH data available.


Related in: MedlinePlus

(a) Physician Global Assessment score over time during treatment with efalizumab (intent-to-treat population, last observation carried forward; N = 189). (b) Proportion of responders (95% CI) achieving a ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (PASI-75) and a ≥50% reduction from baseline in PASI score (PASI-50) over time during treatment with efalizumab (intent-to-treat population, last observation carried forward). (c) Mean and median (95% CI) percentage improvement in PASI score over time during treatment with efalizumab (intent-to-treat population, last observation carried forward).
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fig01: (a) Physician Global Assessment score over time during treatment with efalizumab (intent-to-treat population, last observation carried forward; N = 189). (b) Proportion of responders (95% CI) achieving a ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (PASI-75) and a ≥50% reduction from baseline in PASI score (PASI-50) over time during treatment with efalizumab (intent-to-treat population, last observation carried forward). (c) Mean and median (95% CI) percentage improvement in PASI score over time during treatment with efalizumab (intent-to-treat population, last observation carried forward).

Mentions: In the ITT population, 48.7% (92/189) of patients achieved or maintained a PGA score of “excellent” or “cleared” (95% confidence interval [CI] 41.6–55.8%; Fig. 1a) at Week 24 (nonresponder imputation analysis 46.0% [87/189]; 95% CI 38.9–53.1%); in the PP population this rate was 65.3% (81/124; 95% CI 56.9–73.7%). At Week 24, 67.7% (128/189) in the ITT population achieved or maintained a PGA score of “good” or better (Fig. 1a).


Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results.

Stengel FM, Petri V, Campbell GA, Dorantes GL, López M, Galimberti RL, Valdez RP, de Arruda LF, Guerra MA, Chouela EN, Licu D - Arch Drug Inf (2009)

(a) Physician Global Assessment score over time during treatment with efalizumab (intent-to-treat population, last observation carried forward; N = 189). (b) Proportion of responders (95% CI) achieving a ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (PASI-75) and a ≥50% reduction from baseline in PASI score (PASI-50) over time during treatment with efalizumab (intent-to-treat population, last observation carried forward). (c) Mean and median (95% CI) percentage improvement in PASI score over time during treatment with efalizumab (intent-to-treat population, last observation carried forward).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2805872&req=5

fig01: (a) Physician Global Assessment score over time during treatment with efalizumab (intent-to-treat population, last observation carried forward; N = 189). (b) Proportion of responders (95% CI) achieving a ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (PASI-75) and a ≥50% reduction from baseline in PASI score (PASI-50) over time during treatment with efalizumab (intent-to-treat population, last observation carried forward). (c) Mean and median (95% CI) percentage improvement in PASI score over time during treatment with efalizumab (intent-to-treat population, last observation carried forward).
Mentions: In the ITT population, 48.7% (92/189) of patients achieved or maintained a PGA score of “excellent” or “cleared” (95% confidence interval [CI] 41.6–55.8%; Fig. 1a) at Week 24 (nonresponder imputation analysis 46.0% [87/189]; 95% CI 38.9–53.1%); in the PP population this rate was 65.3% (81/124; 95% CI 56.9–73.7%). At Week 24, 67.7% (128/189) in the ITT population achieved or maintained a PGA score of “good” or better (Fig. 1a).

Bottom Line: Biological therapies offer the possibility of long-term therapy with improved safety and efficacy.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.

View Article: PubMed Central - PubMed

ABSTRACT
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.

No MeSH data available.


Related in: MedlinePlus