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Effect of etanercept therapy on psoriasis symptoms in patients from Latin America, Central Europe, and Asia: a subset analysis of the PRISTINE trial.

Kemeny L, Amaya M, Cetkovska P, Rajatanavin N, Lee WR, Szumski A, Marshall L, Mahgoub EY, Aldinç E - BMC Dermatol. (2015)

Bottom Line: PASI 75 was significantly different between treatment groups from week 8 through the end of study (p<0.05).A more rapid response was observed in patients who received BIW treatment for the first 12 weeks which was sustained after reducing to QW dosing for the subsequent 12 weeks.Response rates were similar to those observed in the overall PRISTINE population.

View Article: PubMed Central - PubMed

Affiliation: Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary. Kemeny.lajos@med.u-szeged.hu.

ABSTRACT

Background: Psoriasis prevalence and characteristics in Asia, Central Europe, and Latin America have not been thoroughly investigated and there are no large trials for biologic treatments for patients from these regions. The goal of this analysis was to report clinical response to anti-tumor necrosis factor-alpha treatment in these patients.

Methods: Patients from Argentina, Czech Republic, Hungary, Mexico, Taiwan, and Thailand (N=171) were included in this subset analysis of the PRISTINE trial. Patients with stable moderate-to-severe plaque psoriasis were blinded and randomized to receive etanercept 50 mg once weekly (QW) or biweekly (BIW) for 12 weeks, followed by 12 weeks of open-label QW treatment with etanercept 50 mg through week 24 (QW/QW vs. BIW/QW). Concomitant methotrexate (≤20 mg/week) and mild topical corticosteroids or other agents were permitted at the physician's discretion, in accordance with therapeutic practice.

Results: As early as week 8, 26.7 % in the etanercept QW group and 44.0 % in the BIW group achieved Psoriasis Area and Severity Index (PASI) 75. At weeks 12 and 24, respectively, PASI 75 increased to 39.5 % and 62.8 % in the QW/QW group and 66.7 % and 83.3 % in the BIW/QW group. PASI 75 was significantly different between treatment groups from week 8 through the end of study (p<0.05). The Kaplan-Meier estimate of the proportions achieving PASI 75 in QW/QW and BIW/QW groups, respectively, was 27.4 % and 45.8 % through week 8; 41.9 % and 68.7 % through week 12; and 72.5 % and 95.2 % through week 24.

Conclusions: Treatment with etanercept 50 mg provided rapid relief of psoriasis symptoms in patients from Asia, Central Europe, and Latin America. A more rapid response was observed in patients who received BIW treatment for the first 12 weeks which was sustained after reducing to QW dosing for the subsequent 12 weeks. Response rates were similar to those observed in the overall PRISTINE population.

Trial registration: ClinicalTrials.gov identifier NCT00663052 .

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Related in: MedlinePlus

PRISTINE study design. BIW: twice weekly; QW: once weekly
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Fig1: PRISTINE study design. BIW: twice weekly; QW: once weekly

Mentions: The details of the PRISTINE trial have been previously published [8]. Briefly, patients ≥18 years of age with stable moderate-to-severe plaque psoriasis were randomized to receive 50 mg etanercept subcutaneously either once weekly (QW) or twice weekly (BIW) for 12 weeks, after which all patients received open-label, 50 mg etanercept subcutaneously QW for an additional 12 weeks, i.e. QW/QW or QW/BIW dosing groups (Fig. 1). Concomitant methotrexate was allowed (≤20 mg/week) if doses were stable from at least 28 days prior to baseline through the end of study. Only mild topical corticosteroids were permitted on scalp, axillae and groin for first 12 weeks; topical medications (corticosteroids of all potencies, vitamin D analogues and combination products) were allowed as needed, at physician’s discretion, during the second 12 weeks, consistent with therapeutic practice. Of the 273 patients enrolled in the PRISTINE trial, 171 patients were eligible for this subset analysis.Fig. 1


Effect of etanercept therapy on psoriasis symptoms in patients from Latin America, Central Europe, and Asia: a subset analysis of the PRISTINE trial.

Kemeny L, Amaya M, Cetkovska P, Rajatanavin N, Lee WR, Szumski A, Marshall L, Mahgoub EY, Aldinç E - BMC Dermatol. (2015)

PRISTINE study design. BIW: twice weekly; QW: once weekly
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4494170&req=5

Fig1: PRISTINE study design. BIW: twice weekly; QW: once weekly
Mentions: The details of the PRISTINE trial have been previously published [8]. Briefly, patients ≥18 years of age with stable moderate-to-severe plaque psoriasis were randomized to receive 50 mg etanercept subcutaneously either once weekly (QW) or twice weekly (BIW) for 12 weeks, after which all patients received open-label, 50 mg etanercept subcutaneously QW for an additional 12 weeks, i.e. QW/QW or QW/BIW dosing groups (Fig. 1). Concomitant methotrexate was allowed (≤20 mg/week) if doses were stable from at least 28 days prior to baseline through the end of study. Only mild topical corticosteroids were permitted on scalp, axillae and groin for first 12 weeks; topical medications (corticosteroids of all potencies, vitamin D analogues and combination products) were allowed as needed, at physician’s discretion, during the second 12 weeks, consistent with therapeutic practice. Of the 273 patients enrolled in the PRISTINE trial, 171 patients were eligible for this subset analysis.Fig. 1

Bottom Line: PASI 75 was significantly different between treatment groups from week 8 through the end of study (p<0.05).A more rapid response was observed in patients who received BIW treatment for the first 12 weeks which was sustained after reducing to QW dosing for the subsequent 12 weeks.Response rates were similar to those observed in the overall PRISTINE population.

View Article: PubMed Central - PubMed

Affiliation: Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary. Kemeny.lajos@med.u-szeged.hu.

ABSTRACT

Background: Psoriasis prevalence and characteristics in Asia, Central Europe, and Latin America have not been thoroughly investigated and there are no large trials for biologic treatments for patients from these regions. The goal of this analysis was to report clinical response to anti-tumor necrosis factor-alpha treatment in these patients.

Methods: Patients from Argentina, Czech Republic, Hungary, Mexico, Taiwan, and Thailand (N=171) were included in this subset analysis of the PRISTINE trial. Patients with stable moderate-to-severe plaque psoriasis were blinded and randomized to receive etanercept 50 mg once weekly (QW) or biweekly (BIW) for 12 weeks, followed by 12 weeks of open-label QW treatment with etanercept 50 mg through week 24 (QW/QW vs. BIW/QW). Concomitant methotrexate (≤20 mg/week) and mild topical corticosteroids or other agents were permitted at the physician's discretion, in accordance with therapeutic practice.

Results: As early as week 8, 26.7 % in the etanercept QW group and 44.0 % in the BIW group achieved Psoriasis Area and Severity Index (PASI) 75. At weeks 12 and 24, respectively, PASI 75 increased to 39.5 % and 62.8 % in the QW/QW group and 66.7 % and 83.3 % in the BIW/QW group. PASI 75 was significantly different between treatment groups from week 8 through the end of study (p<0.05). The Kaplan-Meier estimate of the proportions achieving PASI 75 in QW/QW and BIW/QW groups, respectively, was 27.4 % and 45.8 % through week 8; 41.9 % and 68.7 % through week 12; and 72.5 % and 95.2 % through week 24.

Conclusions: Treatment with etanercept 50 mg provided rapid relief of psoriasis symptoms in patients from Asia, Central Europe, and Latin America. A more rapid response was observed in patients who received BIW treatment for the first 12 weeks which was sustained after reducing to QW dosing for the subsequent 12 weeks. Response rates were similar to those observed in the overall PRISTINE population.

Trial registration: ClinicalTrials.gov identifier NCT00663052 .

Show MeSH
Related in: MedlinePlus