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

Fernando M Stengel, Valeria Petri, Gladys Am Campbell, Gladys Leon Dorantes, Magdalina López, Ricardo L Galimberti, Raúl P Valdez, Lucia F de Arruda, Mario Amaya Guerra, Edgardo N Chouela, Daiana Licu, International IMP25161 Study Group, Fernando M Stengel, Valeria Petri, Gladys Am Campbell, Gladys Leon Dorantes, Magdalina López, Ricardo L Galimberti, Raúl P Valdez, Lucia F de Arruda, Mario Amaya Guerra, Edgardo N Chouela, Daiana Licu, International IMP25161 Study Group

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.

Figures

Figure 1
Figure 1
(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).

References

    1. Naldi L, Griffiths CE. Traditional therapies in the management of moderate to severe chronic plaque psoriasis: An assessment of the benefits and risks. Br J Dermatol. 2005;152:597–615.
    1. Jullien D, Prinz JC, Langley RG, Caro I, Dummer W, Joshi A, et al. T-cell modulation for the treatment of chronic plaque psoriasis with efalizumab (Raptiva): Mechanisms of action. Dermatology. 2004;208:297–306.
    1. Dubertret L, Sterry W, Bos JD, Chimenti S, Shumack S, Larsen CG, et al. Clinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: Results from a Phase III international randomized, placebo-controlled trial. Br J Dermatol. 2006;155:170–81.
    1. Gordon KB, Papp KA, Hamilton TK, Walicke PA, Dummer W, Li N, et al. Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial. JAMA. 2003;290:3073–80.
    1. Gottlieb AB, Gordon KB, Lebwohl MG, Caro I, Walicke PA, Li N, et al. Extended efalizumab therapy sustains efficacy without increasing toxicity in patients with moderate to severe chronic plaque psoriasis. J Drugs Dermatol. 2004;3:614–24.
    1. Gottlieb AB, Hamilton T, Caro I, Kwon P, Compton PG, Leonardi CL, Efalizumab Study Group Long-term continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: updated results from an ongoing trial. J Am Acad Dermatol. 2006;54(4 suppl 1):S154–63.
    1. Lebwohl M, Tyring SK, Hamilton TK, Toth D, Glazer S, Tawfik NH, et al. A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med. 2003;349:2004–13.
    1. Leonardi C, Menter A, Hamilton T, Caro I, Xing B, Gottlieb AB. Efalizumab: Results of a three-year continuous dosing study for the long-term control of psoriasis. Br J Dermatol. 2008;158:1107–16.
    1. Leonardi CL, Papp KA, Gordon KB, Menter A, Feldman SR, Caro I, et al. Extended efalizumab therapy improves chronic plaque psoriasis: Results from a randomized Phase III trial. J Am Acad Dermatol. 2005;52:425–33.
    1. Menter A, Gordon K, Carey W, Hamilton T, Glazer S, Caro I, et al. Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis. Arch Dermatol. 2005;141:31–8.
    1. Papp KA, Henninger E. Evaluation of efalizumab using safe psoriasis control. BMC Dermatol. 2006;6:8.
    1. Papp KA, Henninger E. Safe psoriasis control: A new outcome measure for the composite assessment of the efficacy and safety of psoriasis treatment. J Cutan Med Surg. 2005;9:276–83.
    1. Takahashi MD, Chouela EN, Dorantes GL, Roselino AM, Santamaria J, Allevato MA, et al. Efalizumab in the treatment of scalp, palmoplantar and nail psoriasis: Results of a 24-week Latin American study. Arch Drug Info. 2009 in press.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner