A prospective randomized controlled trial comparing infliximab and etanercept in patients with moderate‐to‐severe chronic plaque‐type psoriasis: the Psoriasis Infliximab vs. Etanercept Comparison Evaluation (PIECE) study

Summary Background There are currently no independent data available comparing infliximab and etanercept for the treatment of psoriasis. Objectives To compare these biologics without funding from pharmaceutical companies. Methods Overall, 50 patients were randomized to etanercept (n = 23) 50 mg subc...

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Veröffentlicht in:British journal of dermatology (1951) 2017-03, Vol.176 (3), p.624-633
Hauptverfasser: Vries, A.C.Q., Thio, H.B., Kort, W.J.A., Opmeer, B.C., Stok, H.M., Jong, E.M.G.J., Horvath, B., Busschbach, J.J.V., Nijsten, T.E.C., Spuls, Ph.I.
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container_end_page 633
container_issue 3
container_start_page 624
container_title British journal of dermatology (1951)
container_volume 176
creator Vries, A.C.Q.
Thio, H.B.
Kort, W.J.A.
Opmeer, B.C.
Stok, H.M.
Jong, E.M.G.J.
Horvath, B.
Busschbach, J.J.V.
Nijsten, T.E.C.
Spuls, Ph.I.
description Summary Background There are currently no independent data available comparing infliximab and etanercept for the treatment of psoriasis. Objectives To compare these biologics without funding from pharmaceutical companies. Methods Overall, 50 patients were randomized to etanercept (n = 23) 50 mg subcutaneously twice weekly or infliximab (n = 25) 5 mg kg−1 intravenously at week 0, 2, 6, 14 and 22. After 24 weeks, 19 patients stopped and 22 continued treatment and were followed up to week 48. The primary outcome was ≥ 75% improvement of Psoriasis Area and Severity Index (PASI 75) at week 24. The secondary outcomes included PASI 75 at week 6 (onset of action) and week 12, Investigator's Global Assessment (IGA), Patient Global Assessment, impact on quality of life (Skindex‐17 and SF‐36), Treatment Satisfaction Questionnaire of Medication, duration of remission, maintenance treatment and safety. Results At week 24, PASI 75 was achieved in 72% (infliximab) vs. 35% (etanercept) (P = 0·01). The onset of action was achieved in 52% (infliximab) and 4% (etanercept). At week 12, 76% (infliximab) and 22% (etanercept) achieved PASI 75 (P < 0·001). At week 24, IGA ‘clear or almost clear’ was observed in 76% (infliximab) and 30% (etanercept) (P = 0·01). Skindex‐17 symptom score was significantly better for infliximab. Maintenance treatment achieved PASI 75 for 67% (n = 6) infliximab vs. 50% (n = 5) etanercept, at week 48 (P = 0·65). Mild adverse events were reported in 76% (infliximab) vs. 66% (etanercept). Conclusions Infliximab showed a rapid and significant higher level of efficacy until week 24 compared with etanercept. Long‐term data showed no significant differences between both groups at week 48. Safety parameters were comparable. What's already known about this topic? Etanercept and infliximab are both effective and safe treatments for psoriasis. No comparative long‐term data are available that are independent from pharmaceutical companies. What does this study add? The onset of action and physician‐reported efficacy for week 12 and 24 is significantly better for infliximab. There was less of a difference in efficacy for patient‐reported outcomes. Long‐term data show no significant differences, based on the duration of remission after stopping treatment and maintenance treatment until week 48. Respond to this article Linked Comment: Burden. Br J Dermatol 2017; 176:565.
doi_str_mv 10.1111/bjd.14867
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Objectives To compare these biologics without funding from pharmaceutical companies. Methods Overall, 50 patients were randomized to etanercept (n = 23) 50 mg subcutaneously twice weekly or infliximab (n = 25) 5 mg kg−1 intravenously at week 0, 2, 6, 14 and 22. After 24 weeks, 19 patients stopped and 22 continued treatment and were followed up to week 48. The primary outcome was ≥ 75% improvement of Psoriasis Area and Severity Index (PASI 75) at week 24. The secondary outcomes included PASI 75 at week 6 (onset of action) and week 12, Investigator's Global Assessment (IGA), Patient Global Assessment, impact on quality of life (Skindex‐17 and SF‐36), Treatment Satisfaction Questionnaire of Medication, duration of remission, maintenance treatment and safety. Results At week 24, PASI 75 was achieved in 72% (infliximab) vs. 35% (etanercept) (P = 0·01). The onset of action was achieved in 52% (infliximab) and 4% (etanercept). At week 12, 76% (infliximab) and 22% (etanercept) achieved PASI 75 (P &lt; 0·001). At week 24, IGA ‘clear or almost clear’ was observed in 76% (infliximab) and 30% (etanercept) (P = 0·01). Skindex‐17 symptom score was significantly better for infliximab. Maintenance treatment achieved PASI 75 for 67% (n = 6) infliximab vs. 50% (n = 5) etanercept, at week 48 (P = 0·65). Mild adverse events were reported in 76% (infliximab) vs. 66% (etanercept). Conclusions Infliximab showed a rapid and significant higher level of efficacy until week 24 compared with etanercept. Long‐term data showed no significant differences between both groups at week 48. Safety parameters were comparable. What's already known about this topic? Etanercept and infliximab are both effective and safe treatments for psoriasis. No comparative long‐term data are available that are independent from pharmaceutical companies. What does this study add? The onset of action and physician‐reported efficacy for week 12 and 24 is significantly better for infliximab. There was less of a difference in efficacy for patient‐reported outcomes. Long‐term data show no significant differences, based on the duration of remission after stopping treatment and maintenance treatment until week 48. Respond to this article Linked Comment: Burden. Br J Dermatol 2017; 176:565.</description><identifier>ISSN: 0007-0963</identifier><identifier>EISSN: 1365-2133</identifier><identifier>DOI: 10.1111/bjd.14867</identifier><identifier>PMID: 27416891</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adolescent ; Adult ; Aged ; Chronic Disease ; Dermatologic Agents - administration &amp; dosage ; Drug Administration Schedule ; Etanercept ; Etanercept - administration &amp; dosage ; Etanercept - adverse effects ; Female ; Humans ; Immunoglobulin A ; Immunotherapy ; Infliximab ; Infliximab - administration &amp; dosage ; Infliximab - adverse effects ; Injections, Subcutaneous ; Male ; Middle Aged ; Monoclonal antibodies ; Patient Satisfaction ; Patients ; Pharmaceutical industry ; Prospective Studies ; Psoriasis ; Psoriasis - drug therapy ; Quality of Life ; Remission ; Single-Blind Method ; Skin ; TNF inhibitors ; Treatment Outcome ; Tumor necrosis factor-α ; Young Adult</subject><ispartof>British journal of dermatology (1951), 2017-03, Vol.176 (3), p.624-633</ispartof><rights>2016 British Association of Dermatologists</rights><rights>2016 British Association of Dermatologists.</rights><rights>Copyright © 2017 British Association of Dermatologists</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3867-54b6fae8de2637210ea1f49e5be190d5aae1d91306b1d6f738ad3f995b2db4313</citedby><cites>FETCH-LOGICAL-c3867-54b6fae8de2637210ea1f49e5be190d5aae1d91306b1d6f738ad3f995b2db4313</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbjd.14867$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjd.14867$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27416891$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vries, A.C.Q.</creatorcontrib><creatorcontrib>Thio, H.B.</creatorcontrib><creatorcontrib>Kort, W.J.A.</creatorcontrib><creatorcontrib>Opmeer, B.C.</creatorcontrib><creatorcontrib>Stok, H.M.</creatorcontrib><creatorcontrib>Jong, E.M.G.J.</creatorcontrib><creatorcontrib>Horvath, B.</creatorcontrib><creatorcontrib>Busschbach, J.J.V.</creatorcontrib><creatorcontrib>Nijsten, T.E.C.</creatorcontrib><creatorcontrib>Spuls, Ph.I.</creatorcontrib><title>A prospective randomized controlled trial comparing infliximab and etanercept in patients with moderate‐to‐severe chronic plaque‐type psoriasis: the Psoriasis Infliximab vs. Etanercept Comparison Evaluation (PIECE) study</title><title>British journal of dermatology (1951)</title><addtitle>Br J Dermatol</addtitle><description>Summary Background There are currently no independent data available comparing infliximab and etanercept for the treatment of psoriasis. Objectives To compare these biologics without funding from pharmaceutical companies. Methods Overall, 50 patients were randomized to etanercept (n = 23) 50 mg subcutaneously twice weekly or infliximab (n = 25) 5 mg kg−1 intravenously at week 0, 2, 6, 14 and 22. After 24 weeks, 19 patients stopped and 22 continued treatment and were followed up to week 48. The primary outcome was ≥ 75% improvement of Psoriasis Area and Severity Index (PASI 75) at week 24. The secondary outcomes included PASI 75 at week 6 (onset of action) and week 12, Investigator's Global Assessment (IGA), Patient Global Assessment, impact on quality of life (Skindex‐17 and SF‐36), Treatment Satisfaction Questionnaire of Medication, duration of remission, maintenance treatment and safety. Results At week 24, PASI 75 was achieved in 72% (infliximab) vs. 35% (etanercept) (P = 0·01). The onset of action was achieved in 52% (infliximab) and 4% (etanercept). At week 12, 76% (infliximab) and 22% (etanercept) achieved PASI 75 (P &lt; 0·001). At week 24, IGA ‘clear or almost clear’ was observed in 76% (infliximab) and 30% (etanercept) (P = 0·01). Skindex‐17 symptom score was significantly better for infliximab. Maintenance treatment achieved PASI 75 for 67% (n = 6) infliximab vs. 50% (n = 5) etanercept, at week 48 (P = 0·65). Mild adverse events were reported in 76% (infliximab) vs. 66% (etanercept). Conclusions Infliximab showed a rapid and significant higher level of efficacy until week 24 compared with etanercept. Long‐term data showed no significant differences between both groups at week 48. Safety parameters were comparable. What's already known about this topic? Etanercept and infliximab are both effective and safe treatments for psoriasis. No comparative long‐term data are available that are independent from pharmaceutical companies. What does this study add? The onset of action and physician‐reported efficacy for week 12 and 24 is significantly better for infliximab. There was less of a difference in efficacy for patient‐reported outcomes. Long‐term data show no significant differences, based on the duration of remission after stopping treatment and maintenance treatment until week 48. Respond to this article Linked Comment: Burden. Br J Dermatol 2017; 176:565.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Chronic Disease</subject><subject>Dermatologic Agents - administration &amp; dosage</subject><subject>Drug Administration Schedule</subject><subject>Etanercept</subject><subject>Etanercept - administration &amp; dosage</subject><subject>Etanercept - adverse effects</subject><subject>Female</subject><subject>Humans</subject><subject>Immunoglobulin A</subject><subject>Immunotherapy</subject><subject>Infliximab</subject><subject>Infliximab - administration &amp; dosage</subject><subject>Infliximab - adverse effects</subject><subject>Injections, Subcutaneous</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Patient Satisfaction</subject><subject>Patients</subject><subject>Pharmaceutical industry</subject><subject>Prospective Studies</subject><subject>Psoriasis</subject><subject>Psoriasis - drug therapy</subject><subject>Quality of Life</subject><subject>Remission</subject><subject>Single-Blind Method</subject><subject>Skin</subject><subject>TNF inhibitors</subject><subject>Treatment Outcome</subject><subject>Tumor necrosis factor-α</subject><subject>Young Adult</subject><issn>0007-0963</issn><issn>1365-2133</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNks1u1DAQxyMEotvCgRdAlri0h2z9kU9u7RJgUSV6gHPkxBPWKycOtrNle-IReMY-CdOmpRISEj7YY89P__nwRNErRpcM12mzVUuWFFn-JFowkaUxZ0I8jRaU0jymZSYOokPvt5QyQVP6PDrgecKyomSL6OaMjM76Edqgd0CcHJTt9TUo0tohOGsMmsFpafChH6XTwzeih87oH7qXDUGeQJADuBbGgB4yyqBhCJ5c6bAhvVXgZICbn7-Cxc3DDhyQduPsoFsyGvl9unPuRyCjtxjJa_-WhA2Qy4crWT8G3PklqR4DruakvB1ItZNmwuBoHl-uq1V1QnyY1P5F9KyTxsPL-_Mo-vq--rL6GF98_rBenV3ErcDWxWnSZJ2EQgHPRM4ZBcm6pIS0AVZSlUoJTJXYwaxhKutyUUglurJMG66aRDBxFB3PuthQLMqHute-BWMwWTv5mhUFy1PGOP8PlGc5TwueIvrmL3RrJzdgITUrOU2SIi9vBU9mqsXP9A66enTYLrevGa1vZ6TGGanvZgTZ1_eKU9OD-kM-DAUCpzNwpQ3s_61Un396N0v-BiImzeU</recordid><startdate>201703</startdate><enddate>201703</enddate><creator>Vries, A.C.Q.</creator><creator>Thio, H.B.</creator><creator>Kort, W.J.A.</creator><creator>Opmeer, B.C.</creator><creator>Stok, H.M.</creator><creator>Jong, E.M.G.J.</creator><creator>Horvath, B.</creator><creator>Busschbach, J.J.V.</creator><creator>Nijsten, T.E.C.</creator><creator>Spuls, Ph.I.</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>201703</creationdate><title>A prospective randomized controlled trial comparing infliximab and etanercept in patients with moderate‐to‐severe chronic plaque‐type psoriasis: the Psoriasis Infliximab vs. Etanercept Comparison Evaluation (PIECE) study</title><author>Vries, A.C.Q. ; Thio, H.B. ; Kort, W.J.A. ; Opmeer, B.C. ; Stok, H.M. ; Jong, E.M.G.J. ; Horvath, B. ; Busschbach, J.J.V. ; Nijsten, T.E.C. ; Spuls, Ph.I.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3867-54b6fae8de2637210ea1f49e5be190d5aae1d91306b1d6f738ad3f995b2db4313</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Chronic Disease</topic><topic>Dermatologic Agents - administration &amp; dosage</topic><topic>Drug Administration Schedule</topic><topic>Etanercept</topic><topic>Etanercept - administration &amp; dosage</topic><topic>Etanercept - adverse effects</topic><topic>Female</topic><topic>Humans</topic><topic>Immunoglobulin A</topic><topic>Immunotherapy</topic><topic>Infliximab</topic><topic>Infliximab - administration &amp; dosage</topic><topic>Infliximab - adverse effects</topic><topic>Injections, Subcutaneous</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Monoclonal antibodies</topic><topic>Patient Satisfaction</topic><topic>Patients</topic><topic>Pharmaceutical industry</topic><topic>Prospective Studies</topic><topic>Psoriasis</topic><topic>Psoriasis - drug therapy</topic><topic>Quality of Life</topic><topic>Remission</topic><topic>Single-Blind Method</topic><topic>Skin</topic><topic>TNF inhibitors</topic><topic>Treatment Outcome</topic><topic>Tumor necrosis factor-α</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vries, A.C.Q.</creatorcontrib><creatorcontrib>Thio, H.B.</creatorcontrib><creatorcontrib>Kort, W.J.A.</creatorcontrib><creatorcontrib>Opmeer, B.C.</creatorcontrib><creatorcontrib>Stok, H.M.</creatorcontrib><creatorcontrib>Jong, E.M.G.J.</creatorcontrib><creatorcontrib>Horvath, B.</creatorcontrib><creatorcontrib>Busschbach, J.J.V.</creatorcontrib><creatorcontrib>Nijsten, T.E.C.</creatorcontrib><creatorcontrib>Spuls, Ph.I.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>British journal of dermatology (1951)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vries, A.C.Q.</au><au>Thio, H.B.</au><au>Kort, W.J.A.</au><au>Opmeer, B.C.</au><au>Stok, H.M.</au><au>Jong, E.M.G.J.</au><au>Horvath, B.</au><au>Busschbach, J.J.V.</au><au>Nijsten, T.E.C.</au><au>Spuls, Ph.I.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A prospective randomized controlled trial comparing infliximab and etanercept in patients with moderate‐to‐severe chronic plaque‐type psoriasis: the Psoriasis Infliximab vs. Etanercept Comparison Evaluation (PIECE) study</atitle><jtitle>British journal of dermatology (1951)</jtitle><addtitle>Br J Dermatol</addtitle><date>2017-03</date><risdate>2017</risdate><volume>176</volume><issue>3</issue><spage>624</spage><epage>633</epage><pages>624-633</pages><issn>0007-0963</issn><eissn>1365-2133</eissn><abstract>Summary Background There are currently no independent data available comparing infliximab and etanercept for the treatment of psoriasis. Objectives To compare these biologics without funding from pharmaceutical companies. Methods Overall, 50 patients were randomized to etanercept (n = 23) 50 mg subcutaneously twice weekly or infliximab (n = 25) 5 mg kg−1 intravenously at week 0, 2, 6, 14 and 22. After 24 weeks, 19 patients stopped and 22 continued treatment and were followed up to week 48. The primary outcome was ≥ 75% improvement of Psoriasis Area and Severity Index (PASI 75) at week 24. The secondary outcomes included PASI 75 at week 6 (onset of action) and week 12, Investigator's Global Assessment (IGA), Patient Global Assessment, impact on quality of life (Skindex‐17 and SF‐36), Treatment Satisfaction Questionnaire of Medication, duration of remission, maintenance treatment and safety. Results At week 24, PASI 75 was achieved in 72% (infliximab) vs. 35% (etanercept) (P = 0·01). The onset of action was achieved in 52% (infliximab) and 4% (etanercept). At week 12, 76% (infliximab) and 22% (etanercept) achieved PASI 75 (P &lt; 0·001). At week 24, IGA ‘clear or almost clear’ was observed in 76% (infliximab) and 30% (etanercept) (P = 0·01). Skindex‐17 symptom score was significantly better for infliximab. Maintenance treatment achieved PASI 75 for 67% (n = 6) infliximab vs. 50% (n = 5) etanercept, at week 48 (P = 0·65). Mild adverse events were reported in 76% (infliximab) vs. 66% (etanercept). Conclusions Infliximab showed a rapid and significant higher level of efficacy until week 24 compared with etanercept. Long‐term data showed no significant differences between both groups at week 48. Safety parameters were comparable. What's already known about this topic? Etanercept and infliximab are both effective and safe treatments for psoriasis. No comparative long‐term data are available that are independent from pharmaceutical companies. What does this study add? The onset of action and physician‐reported efficacy for week 12 and 24 is significantly better for infliximab. There was less of a difference in efficacy for patient‐reported outcomes. Long‐term data show no significant differences, based on the duration of remission after stopping treatment and maintenance treatment until week 48. Respond to this article Linked Comment: Burden. Br J Dermatol 2017; 176:565.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>27416891</pmid><doi>10.1111/bjd.14867</doi><tpages>10</tpages></addata></record>
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source Oxford University Press Journals All Titles (1996-Current); MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects Adolescent
Adult
Aged
Chronic Disease
Dermatologic Agents - administration & dosage
Drug Administration Schedule
Etanercept
Etanercept - administration & dosage
Etanercept - adverse effects
Female
Humans
Immunoglobulin A
Immunotherapy
Infliximab
Infliximab - administration & dosage
Infliximab - adverse effects
Injections, Subcutaneous
Male
Middle Aged
Monoclonal antibodies
Patient Satisfaction
Patients
Pharmaceutical industry
Prospective Studies
Psoriasis
Psoriasis - drug therapy
Quality of Life
Remission
Single-Blind Method
Skin
TNF inhibitors
Treatment Outcome
Tumor necrosis factor-α
Young Adult
title A prospective randomized controlled trial comparing infliximab and etanercept in patients with moderate‐to‐severe chronic plaque‐type psoriasis: the Psoriasis Infliximab vs. Etanercept Comparison Evaluation (PIECE) study
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