Clinically meaningful improvement in work productivity loss in active psoriatic arthritis: post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 trials
To determine the proportion of patients in Phase 3 studies (SPIRIT-P1 and SPIRIT-P2) who achieved minimal clinically important difference (MCID) for work productivity loss and activity impairment domains of Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) questionnaire. I...
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| Veröffentlicht in: | Clinical and experimental rheumatology 2020-11, Vol.38 (6), p.1227-1230 |
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| creator | Tillett, William Lin, Chen-Yen Trevelin Sprabery, Aubrey Birt, Julie A Kavanaugh, Arthur |
| description | To determine the proportion of patients in Phase 3 studies (SPIRIT-P1 and SPIRIT-P2) who achieved minimal clinically important difference (MCID) for work productivity loss and activity impairment domains of Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) questionnaire.
In the SPIRIT-P1 study, comprising a 24-week double-blind treatment period, biologic-naive patients with active psoriatic arthritis (PsA) were randomised to ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) (starting dose of 160 mg), adalimumab 40 mg every 2 weeks (ADAQ2W), or placebo. SPIRIT-P2 enrolled tumour necrosis factor inhibitor (TNFi)-experienced patients who were randomised to receive IXEQ4W, IXEQ2W or placebo for 24 weeks of double-blind treatment. In this post-hoc analysis, we investigated the proportion of patients in SPIRIT-P1 and P2 studies who achieved 15% improvement in work productivity loss and 20% improvement in activity impairment domains of WPAI-SHP during double- blind treatment period.
In SPIRIT-P1, at Week 24, 57.1% and 55.8% of biologic-naive patients on IXEQ4W and ADAQ2W respectively, achieved MCID estimates for work productivity loss compared to 25.6% of patients treated with placebo. The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p |
| format | Article |
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In the SPIRIT-P1 study, comprising a 24-week double-blind treatment period, biologic-naive patients with active psoriatic arthritis (PsA) were randomised to ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) (starting dose of 160 mg), adalimumab 40 mg every 2 weeks (ADAQ2W), or placebo. SPIRIT-P2 enrolled tumour necrosis factor inhibitor (TNFi)-experienced patients who were randomised to receive IXEQ4W, IXEQ2W or placebo for 24 weeks of double-blind treatment. In this post-hoc analysis, we investigated the proportion of patients in SPIRIT-P1 and P2 studies who achieved 15% improvement in work productivity loss and 20% improvement in activity impairment domains of WPAI-SHP during double- blind treatment period.
In SPIRIT-P1, at Week 24, 57.1% and 55.8% of biologic-naive patients on IXEQ4W and ADAQ2W respectively, achieved MCID estimates for work productivity loss compared to 25.6% of patients treated with placebo. The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: p=0.001) com- pared to placebo-treated patients at Week 24. In SPIRIT-P2, significantly more TNFi-experienced patients on IXEQ4W (p<0.001) achieved MCIDs compared to placebo at Week 24.
Treatment with ixekizumab was associated with clinically meaningful improvements in WPAI-SHP domains in biologic-naive and TNFi- experienced patients with active PsA.</description><identifier>ISSN: 0392-856X</identifier><identifier>PMID: 32452352</identifier><language>eng</language><publisher>Italy</publisher><subject>Adalimumab - therapeutic use ; Antirheumatic Agents - therapeutic use ; Arthritis, Psoriatic - diagnosis ; Arthritis, Psoriatic - drug therapy ; Dermatologic Agents - therapeutic use ; Double-Blind Method ; Efficiency ; Humans ; Treatment Outcome</subject><ispartof>Clinical and experimental rheumatology, 2020-11, Vol.38 (6), p.1227-1230</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32452352$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tillett, William</creatorcontrib><creatorcontrib>Lin, Chen-Yen</creatorcontrib><creatorcontrib>Trevelin Sprabery, Aubrey</creatorcontrib><creatorcontrib>Birt, Julie A</creatorcontrib><creatorcontrib>Kavanaugh, Arthur</creatorcontrib><title>Clinically meaningful improvement in work productivity loss in active psoriatic arthritis: post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 trials</title><title>Clinical and experimental rheumatology</title><addtitle>Clin Exp Rheumatol</addtitle><description>To determine the proportion of patients in Phase 3 studies (SPIRIT-P1 and SPIRIT-P2) who achieved minimal clinically important difference (MCID) for work productivity loss and activity impairment domains of Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) questionnaire.
In the SPIRIT-P1 study, comprising a 24-week double-blind treatment period, biologic-naive patients with active psoriatic arthritis (PsA) were randomised to ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) (starting dose of 160 mg), adalimumab 40 mg every 2 weeks (ADAQ2W), or placebo. SPIRIT-P2 enrolled tumour necrosis factor inhibitor (TNFi)-experienced patients who were randomised to receive IXEQ4W, IXEQ2W or placebo for 24 weeks of double-blind treatment. In this post-hoc analysis, we investigated the proportion of patients in SPIRIT-P1 and P2 studies who achieved 15% improvement in work productivity loss and 20% improvement in activity impairment domains of WPAI-SHP during double- blind treatment period.
In SPIRIT-P1, at Week 24, 57.1% and 55.8% of biologic-naive patients on IXEQ4W and ADAQ2W respectively, achieved MCID estimates for work productivity loss compared to 25.6% of patients treated with placebo. The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: p=0.001) com- pared to placebo-treated patients at Week 24. In SPIRIT-P2, significantly more TNFi-experienced patients on IXEQ4W (p<0.001) achieved MCIDs compared to placebo at Week 24.
Treatment with ixekizumab was associated with clinically meaningful improvements in WPAI-SHP domains in biologic-naive and TNFi- experienced patients with active PsA.</description><subject>Adalimumab - therapeutic use</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Arthritis, Psoriatic - diagnosis</subject><subject>Arthritis, Psoriatic - drug therapy</subject><subject>Dermatologic Agents - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Efficiency</subject><subject>Humans</subject><subject>Treatment Outcome</subject><issn>0392-856X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kM1OwzAQhHMA0VJ4BeQjl0j-T8INVfxUqkQFReIWufaGGpw4xE6rvATPTCoKp9F-O7PS7EkyxaygaS7k2yQ5D-EDYyqFzM6SCaNcUCboNPmeO9tYrZwbUA2qsc171Ttk67bzO6ihicg2aO-7TzQS0-todzYOyPkQDht1AIDa4DurotVIdXHb2WjDDWp9iOnWj6xRbgg2IF-hl9XiebFOV2Sk5n-iKI55Fy6S02oUuDzqLHm9v1vPH9Pl08NifrtMW0pITBlAJkVOGKtYATqXYDIQBCAHXRWYyA3OOMmKzBgMnGtjNMeMAcm1xtpINkuuf--Opb56CLGsbdDgnGrA96GkHMuCC1IUo_XqaO03NZiy7WytuqH8-yH7Aa2wbsQ</recordid><startdate>202011</startdate><enddate>202011</enddate><creator>Tillett, William</creator><creator>Lin, Chen-Yen</creator><creator>Trevelin Sprabery, Aubrey</creator><creator>Birt, Julie A</creator><creator>Kavanaugh, Arthur</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>202011</creationdate><title>Clinically meaningful improvement in work productivity loss in active psoriatic arthritis: post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 trials</title><author>Tillett, William ; Lin, Chen-Yen ; Trevelin Sprabery, Aubrey ; Birt, Julie A ; Kavanaugh, Arthur</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p211t-3ee7658133f39ec86ed7e51ee8ecf9016b0741797dd0e44cddc4033e18cc0cd63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adalimumab - therapeutic use</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Arthritis, Psoriatic - diagnosis</topic><topic>Arthritis, Psoriatic - drug therapy</topic><topic>Dermatologic Agents - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Efficiency</topic><topic>Humans</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tillett, William</creatorcontrib><creatorcontrib>Lin, Chen-Yen</creatorcontrib><creatorcontrib>Trevelin Sprabery, Aubrey</creatorcontrib><creatorcontrib>Birt, Julie A</creatorcontrib><creatorcontrib>Kavanaugh, Arthur</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical and experimental rheumatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tillett, William</au><au>Lin, Chen-Yen</au><au>Trevelin Sprabery, Aubrey</au><au>Birt, Julie A</au><au>Kavanaugh, Arthur</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinically meaningful improvement in work productivity loss in active psoriatic arthritis: post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 trials</atitle><jtitle>Clinical and experimental rheumatology</jtitle><addtitle>Clin Exp Rheumatol</addtitle><date>2020-11</date><risdate>2020</risdate><volume>38</volume><issue>6</issue><spage>1227</spage><epage>1230</epage><pages>1227-1230</pages><issn>0392-856X</issn><abstract>To determine the proportion of patients in Phase 3 studies (SPIRIT-P1 and SPIRIT-P2) who achieved minimal clinically important difference (MCID) for work productivity loss and activity impairment domains of Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) questionnaire.
In the SPIRIT-P1 study, comprising a 24-week double-blind treatment period, biologic-naive patients with active psoriatic arthritis (PsA) were randomised to ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) (starting dose of 160 mg), adalimumab 40 mg every 2 weeks (ADAQ2W), or placebo. SPIRIT-P2 enrolled tumour necrosis factor inhibitor (TNFi)-experienced patients who were randomised to receive IXEQ4W, IXEQ2W or placebo for 24 weeks of double-blind treatment. In this post-hoc analysis, we investigated the proportion of patients in SPIRIT-P1 and P2 studies who achieved 15% improvement in work productivity loss and 20% improvement in activity impairment domains of WPAI-SHP during double- blind treatment period.
In SPIRIT-P1, at Week 24, 57.1% and 55.8% of biologic-naive patients on IXEQ4W and ADAQ2W respectively, achieved MCID estimates for work productivity loss compared to 25.6% of patients treated with placebo. The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: p=0.001) com- pared to placebo-treated patients at Week 24. In SPIRIT-P2, significantly more TNFi-experienced patients on IXEQ4W (p<0.001) achieved MCIDs compared to placebo at Week 24.
Treatment with ixekizumab was associated with clinically meaningful improvements in WPAI-SHP domains in biologic-naive and TNFi- experienced patients with active PsA.</abstract><cop>Italy</cop><pmid>32452352</pmid><tpages>4</tpages></addata></record> |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Adalimumab - therapeutic use Antirheumatic Agents - therapeutic use Arthritis, Psoriatic - diagnosis Arthritis, Psoriatic - drug therapy Dermatologic Agents - therapeutic use Double-Blind Method Efficiency Humans Treatment Outcome |
| title | Clinically meaningful improvement in work productivity loss in active psoriatic arthritis: post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 trials |
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