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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

Effect on PGA a and BSA b scores in response to etanercept by treatment group (LOCF data). *p < 0.0001. BIW: twice weekly; BSA: body surface area; LOCF: last observation carried forward; PGA: Physician’s Global Assessment; QW: once weekly
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Fig4: Effect on PGA a and BSA b scores in response to etanercept by treatment group (LOCF data). *p < 0.0001. BIW: twice weekly; BSA: body surface area; LOCF: last observation carried forward; PGA: Physician’s Global Assessment; QW: once weekly

Mentions: There were more patients achieving PASI 50, PASI 75, and PASI 90 in the group that received etanercept 50 mg BIW than in the group that received etanercept 50 mg QW over the time course of the study (Fig. 3). Statistically significant difference between the two treatment groups was evident as early as week 4 in PASI 50. Statistically significant difference in PASI 75 was observed by week 8 and in PASI 90 by week 12 (Fig. 3). After 12 weeks of treatment, i.e. at the end of the blinded phase of the study, 72 %, 40 % and 14 % of patients in the QW/QW group and 92 %, 67 % and 32 % in the BIW/QW group achieved PASI 50, PASI 75 and PASI 90, respectively. Kaplan-Meier estimates of the proportions of patients achieving first PASI 50, PASI 75 and PASI 90 responses by weeks 8, 12 and 24 also indicate a strong beneficial response in both treatment groups (Table 3). Improvements from baseline were also observed in PGA and BSA scores (p < 0.0001) at weeks 12 and 24 in both treatment groups (Fig. 4). By week 12, 36 % and 56 % of patients in the QW/QW and BIW/QW groups, respectively, exhibited a PGA status of clear or almost clear (Table 4). By week 24, the number of patients with clear or almost clear status increased to 57 % and 71 % in the QW/QW and BIW/QW groups, respectively. For the achievement of first PGA of clear/almost clear response, there was a statistically significant difference between the time-to-event curves for the QW/QW and BIW/QW treatment arms (p = 0.0112) and a significantly higher median time-to-response for the QW/QW group (113 days; 95 % confidence interval [CI]: 85–141) compared with the BIW/QW group (85 days; 95 % CI: 59–86). The efficacy parameters are summarized in Table 4.Fig. 3


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)

Effect on PGA a and BSA b scores in response to etanercept by treatment group (LOCF data). *p < 0.0001. BIW: twice weekly; BSA: body surface area; LOCF: last observation carried forward; PGA: Physician’s Global Assessment; QW: once weekly
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig4: Effect on PGA a and BSA b scores in response to etanercept by treatment group (LOCF data). *p < 0.0001. BIW: twice weekly; BSA: body surface area; LOCF: last observation carried forward; PGA: Physician’s Global Assessment; QW: once weekly
Mentions: There were more patients achieving PASI 50, PASI 75, and PASI 90 in the group that received etanercept 50 mg BIW than in the group that received etanercept 50 mg QW over the time course of the study (Fig. 3). Statistically significant difference between the two treatment groups was evident as early as week 4 in PASI 50. Statistically significant difference in PASI 75 was observed by week 8 and in PASI 90 by week 12 (Fig. 3). After 12 weeks of treatment, i.e. at the end of the blinded phase of the study, 72 %, 40 % and 14 % of patients in the QW/QW group and 92 %, 67 % and 32 % in the BIW/QW group achieved PASI 50, PASI 75 and PASI 90, respectively. Kaplan-Meier estimates of the proportions of patients achieving first PASI 50, PASI 75 and PASI 90 responses by weeks 8, 12 and 24 also indicate a strong beneficial response in both treatment groups (Table 3). Improvements from baseline were also observed in PGA and BSA scores (p < 0.0001) at weeks 12 and 24 in both treatment groups (Fig. 4). By week 12, 36 % and 56 % of patients in the QW/QW and BIW/QW groups, respectively, exhibited a PGA status of clear or almost clear (Table 4). By week 24, the number of patients with clear or almost clear status increased to 57 % and 71 % in the QW/QW and BIW/QW groups, respectively. For the achievement of first PGA of clear/almost clear response, there was a statistically significant difference between the time-to-event curves for the QW/QW and BIW/QW treatment arms (p = 0.0112) and a significantly higher median time-to-response for the QW/QW group (113 days; 95 % confidence interval [CI]: 85–141) compared with the BIW/QW group (85 days; 95 % CI: 59–86). The efficacy parameters are summarized in Table 4.Fig. 3

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