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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Psoriasis is a chronic&#44; immune-mediated inflammatory disorder affecting 2&#8211;3&#37; of general population&#44; being both physically and emotionally debilitating&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Due to the rapid advances in the understanding of psoriasis pathogenesis&#44; several targeted medications&#44; aiming specific components of the immune system&#44; have been and are currently being developed&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> These biologic therapies are a major technological advancement over traditional immunosuppressive medications and have revolutionized the treatment of psoriasis&#46; Currently available biologic agents for psoriasis treatment have shown to be very effective&#44; even long-term&#44; with a favorable safety profile&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The most widely used instrument for objective measurement of psoriasis severity and extension is the Psoriasis Area and Severity Index &#40;PASI&#41;&#44; which was developed in 1978&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Even though it has a number of limitations &#40;non-linearity because of the surface score&#44; notorious floor effect and poor sensitivity to change for relatively small areas of involvement&#44; lack of ponderation of the different qualities of the lesions and functional impairment associated with lesions involving visible areas&#44; such as&#44; the hands&#44; feet&#44; nails or genital areas and reduced reproducibility due to the variability associated to the determination of BSA<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a>&#41;&#44; PASI has been considered the gold standard of psoriasis severity scale for decades&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">A 75&#37; reduction in the PASI score with respect to baseline &#40;PASI 75&#41; is the current standard of response assessment used for primary endpoints in most clinical trials of psoriasis and it has been considered the treatment goal for moderate to severe psoriasis in a recent European consensus&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">However&#44; not so long ago&#44; some authors considered PASI 75 to be too stringent&#44; placing potentially useful therapies at risk of failing to demonstrate efficacy&#44; and PASI 50 to represent a clinically significant change for psoriasis patients and a better primary endpoint&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> This may have been true in an era of less effective drugs but&#44; in the current status of biologic treatment&#44; more ambitious outcome measures must be chose&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Although PASI 75 response is commonly used as the primary efficacy endpoint in clinical trials of biologics&#44; PASI 90 and even PASI 100 response rates are commonly reported and are becoming important secondary endpoints&#46; As is often the case&#44; technological&#47;therapeutic advances precede and eventually determine changes in therapeutic paradigms&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The efficacy showed by the IL-17 inhibitors &#40;both IL-17A and IL-17 receptor subunit A inhibitors&#41; in phase II and phase III clinical trials&#44; which bears the promise of achieving PASI 90 response or better in the majority of patients&#44; may make us rethink this issue again&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Methotrexate showed&#44; in the randomized controlled comparative trials of infliximab and adalimumab&#44; a 16 and 26-week PASI 90 response between 14&#8211;19&#46;1&#37; and 14&#46;9&#37;&#44; respectively&#46;<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">8&#44;9</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">Considering biologic therapy&#44; the week-12 PASI 90 rate in publish randomized trials of efalizumab&#44; one of the first biologic agents approved for psoriasis and later withdrawn&#44; was between 4&#8211;12&#37;&#44;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> while the results of a 3-year continuous dosing study&#44; showed a PASI 90 response of 24&#46;5&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">The anti-TNF&#945; therapies show better results&#44; with the monoclonal antibodies infliximab and adalimumab showing a higher response rate than the soluble TNF&#945; receptor etanercept in clinical trials&#46; In a recently published meta-analysis the efficacy of biologics in the treatment of moderate-to-severe plaque psoriasis based on the available randomized controlled trials has been estimated&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> The probability of achieving a PASI 90 response at the primary endpoint time is 19&#46;3&#37; &#40;95&#37; CI&#58; 16&#46;6&#8211;22&#46;0&#41; for etanercept at week 12&#44; 36&#46;5&#37; &#40;95&#37; CI&#58; 25&#46;7&#8211;47&#46;4&#41; for adalimumab at week 16 and 49&#46;5&#37; &#40;95&#37; CI&#58; 45&#46;6&#8211;53&#46;4&#41; for infliximab at week 10&#46; At week 24 the probability of achieving a PASI 90 response is 27&#46;8&#37; &#40;95&#37; CI&#58; 23&#46;6&#8211;31&#46;9&#41;&#44; 45&#46;7&#37; &#40;95&#37; CI&#58; 42&#46;1&#8211;49&#46;3&#41; and 50&#46;6&#37; &#40;95&#37; CI&#58; 45&#46;3&#8211;55&#46;9&#41; respectively for etanercept&#44; adalimumab and infliximab&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> In the long term&#44; the reported PASI 90 response in the open-label extension studies RESTORE and REVEAL was 45&#37; for infliximab at week 50 and 50&#37; for adalimumab at 3 years&#46;<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13&#44;14</span></a> Regarding ustekinumab&#44; the latest biologic agent approved for treatment of moderate to severe psoriasis&#44; the results observed in the phase III clinical trials were similar to the response rates observed with the anti-TNF&#945; monoclonal antibodies&#46; In the same meta-analysis&#44; the probability of achieving a PASI 90 response at week 12 and 24 is 47&#46;2&#37; &#40;95&#37; CI&#58; 42&#46;6&#8211;51&#46;8&#41; and 58&#46;2&#37; &#40;95&#37; CI&#58; 53&#46;7&#8211;62&#46;8&#41; respectively for the 45<span class="elsevierStyleHsp" style=""></span>mg dose&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> In the long-term efficacy analyze of ustekinumab in patients treated for up to 5 years in the PHOENIX 1 study&#44; the 5-year PASI 90 response rate reported was 39&#46;7&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Looking to the recently published results of phase II and phase III randomized trials of secukinumab&#44; ixekizumab &#40;both anti-IL-17A monoclonal antibodies&#41; and brodalumab &#40;anti-IL-17 receptor subunit A monoclonal antibody&#41; PASI 90 and PASI 100 response rates are impressive&#46; In the phase II&#44; randomized&#44; double-blind&#44; placebo-controlled&#44; dose-ranging study of brodalumab&#44; a PASI 90 and PASI 100 response was observed in 75&#37; and 62&#37;&#44; respectively of the patients in the 210<span class="elsevierStyleHsp" style=""></span>mg group at week 12&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> In the 48-week open-label extension of the phase II trial&#44; 86&#37; and 64&#37; of the patients achieved&#44; respectively&#44; PASI 90 and PASI 100 at week 48<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a>&#46; Concerning the phase II&#44; double-blind&#44; placebo-controlled trial with ixekizumab at 12 weeks&#44; the percentage of patients with PASI 90 and PASI 100 response was 71&#37; and 39&#37; respectively&#44; in the group of patients treated with 150<span class="elsevierStyleHsp" style=""></span>mg and 59&#37; and 38&#37; respectively in the 75<span class="elsevierStyleHsp" style=""></span>mg group&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> In the open-label extension&#44; with a dose of 120<span class="elsevierStyleHsp" style=""></span>mg every 4 week&#44; 79&#37; and 57&#37; achieved a PASI 90 and PASI 100 response after 52 weeks&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> In the phase II&#44; randomized&#44; double-blind&#44; placebo-controlled dose-ranging study of secukinumab the 12-week PASI 90 response in the 150<span class="elsevierStyleHsp" style=""></span>mg group was 52&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> In the phase III FIXTURE study&#44; comparing two doses of secukinumab &#40;300<span class="elsevierStyleHsp" style=""></span>mg and 150<span class="elsevierStyleHsp" style=""></span>mg&#41; with etanercept and placebo&#44; the 12-week PASI 90 and PASI 100 response in the 300<span class="elsevierStyleHsp" style=""></span>mg secukinumab group was 54&#37; and 24&#37; respectively&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> At week 52&#44; 65&#37; of the patients treated with secukinumab 300<span class="elsevierStyleHsp" style=""></span>mg monthly had a PASI 90 response&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> In other phase III study&#44; the ERASURE study&#44; the 12-week PASI 90 and PASI 100 response was 59&#46;2&#37; and 28&#46;6&#37; respectively&#46; At week 52&#44; nearly 60&#37; of the patients treated with secukinumab 300<span class="elsevierStyleHsp" style=""></span>mg monthly had a PASI 90 response&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">These results are in fact very promising&#44; but confirmation both from further clinical trials and particularly daily clinical practice is necessary&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">PASI 90 may represent the best meaningful clinical response&#44; instead of PASI 75&#44; particularly in patients with very severe psoriasis&#46; Considering patients with PASI above 20 &#40;as seen in most studies in moderate to severe psoriasis&#41;&#44; a PASI 75 response would associate to an absolute PASI around 5&#44; compatible with a PGA score of 2&#44; usually considered mild psoriasis &#40;mild plaque elevation&#44; light red coloration&#44; predomination of fine scale&#41;&#46; However PASI 90 response would equate to a PASI around 2&#44; compatible with a PGA of 0&#47;1 &#40;almost clear&#41;&#46; In this sense&#44; PASI 90 response probably better reflects a &#8220;clear&#8221;&#47;&#8220;almost clear&#8221; status than PASI 75&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">22</span></a> Moreover&#44; it is well known that reduction in PASI predicts a reduction in DLQI with a good correlation&#46; A recent systematic review showed that a PASI 75 response was associated with a considerably higher mean DLQI change &#40;9&#46;36&#41; than a PASI 50&#8211;75 response &#40;6&#46;12&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a> The difference between both groups was 3&#46;24&#44; higher than 3&#46;2&#44; the value considered clinically meaningful according to the proposed minimal clinically important difference for the DLQI in psoriasis&#46;<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">23&#44;24</span></a> This data suggests that there is a true quality-of-life benefit associated with higher levels of psoriasis clearance&#44; and that higher PASI reductions &#40;for instance PASI 90&#41; may probably determine even better quality-of-life benefits&#46; As a matter of fact&#44; combining data from two adalimumab trials&#44; the PASI 100 and PASI 90 to &#60;100 groups demonstrated a &#62;10-point decrease in DLQI total scores at week 16&#44; and these changes were statistically significantly greater than those observed for the PASI 75 to &#60;90 group and the other PASI response groups &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">25</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">The ultimate goal of psoriasis treatment is the complete clearance of all skin lesions and symptoms&#44; however&#44; when pushing the response rate so high&#44; safety concerns must be considered&#46; The immunomodulatory&#47;immunosuppressive effects of these agents should not be forgotten and holding the balance is the key&#46; Nevertheless the safety data on these new agents is reassuring&#44; appointing to a favorable safety profile&#46; The expected favorable safety&#47;efficacy ratio of the IL-17 inhibitors is probably related to the selective mechanism of action of these new drugs&#44; as a lower blockade in the inflammatory cascade may result in less immunosuppression and consequently in less risks of infection and malignancy&#44; while maintaining a high efficacy through selectively acting at the level of this key effector cytokine&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">26</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">The psoriasis treatment paradigm has changed with the advent of biologics&#46; The treatment advancements we have seen with these agents make us believe that achieving clearance or near-clearance of psoriasis will be possible&#46; If in the past&#44; a PASI 50 and 75 response was possibly sufficient enough and the PASI 90 achievement just a mirage&#44; maybe sooner than many expected&#44; clinicians will be disappointed if a PASI 90 response is not achieved&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interest</span><p id="par0080" class="elsevierStylePara elsevierViewall">Dr&#46; T&#46; Torres has participated in clinical trial sponsored by Abbvie&#44; Amgen and Novartis and has received honoraria for acting as a consultant and&#47;or as a speaker at events sponsored by Abbvie&#44; Janssen&#44; MSD and Pfizer&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">Prof&#46; L&#46; Puig has participated in clinical trials sponsored by Abbvie&#44; Amgen&#44; Lilly&#44; Merck&#44; Novartis&#44; Pfizer Espa&#241;a&#44; and VBL and has received honoraria for acting as a consultant and as a speaker at events sponsored by Abbvie&#44; Merck&#44; Janssen&#44; Merck&#44; Novartis&#44; and Pfizer&#46;</p></span></span>"
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Opinion Article
Treatment goals for psoriasis: Should PASI 90 become the standard of care?
Objetivos terapéuticos en la psoriasis: ¿debería ser la respuesta PASI90 la norma asistencial?
T. Torresa,b,
Corresponding author
tiagotorres2002@hotmail.com

Corresponding author.
, L. Puigc,d
a Department of Dermatology, Centro Hospitalar do Porto, Portugal
b Instituto de Ciências Biomédicas Abel Salazar, University of Porto, Portugal
c Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
d Universitat Autònoma de Barcelona, Barcelona, Spain
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        "titulo" => "Objetivos terap&#233;uticos en la psoriasis&#58; &#191;deber&#237;a ser la respuesta PASI90 la norma asistencial&#63;"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Psoriasis is a chronic&#44; immune-mediated inflammatory disorder affecting 2&#8211;3&#37; of general population&#44; being both physically and emotionally debilitating&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Due to the rapid advances in the understanding of psoriasis pathogenesis&#44; several targeted medications&#44; aiming specific components of the immune system&#44; have been and are currently being developed&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> These biologic therapies are a major technological advancement over traditional immunosuppressive medications and have revolutionized the treatment of psoriasis&#46; Currently available biologic agents for psoriasis treatment have shown to be very effective&#44; even long-term&#44; with a favorable safety profile&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The most widely used instrument for objective measurement of psoriasis severity and extension is the Psoriasis Area and Severity Index &#40;PASI&#41;&#44; which was developed in 1978&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Even though it has a number of limitations &#40;non-linearity because of the surface score&#44; notorious floor effect and poor sensitivity to change for relatively small areas of involvement&#44; lack of ponderation of the different qualities of the lesions and functional impairment associated with lesions involving visible areas&#44; such as&#44; the hands&#44; feet&#44; nails or genital areas and reduced reproducibility due to the variability associated to the determination of BSA<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a>&#41;&#44; PASI has been considered the gold standard of psoriasis severity scale for decades&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">A 75&#37; reduction in the PASI score with respect to baseline &#40;PASI 75&#41; is the current standard of response assessment used for primary endpoints in most clinical trials of psoriasis and it has been considered the treatment goal for moderate to severe psoriasis in a recent European consensus&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">However&#44; not so long ago&#44; some authors considered PASI 75 to be too stringent&#44; placing potentially useful therapies at risk of failing to demonstrate efficacy&#44; and PASI 50 to represent a clinically significant change for psoriasis patients and a better primary endpoint&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> This may have been true in an era of less effective drugs but&#44; in the current status of biologic treatment&#44; more ambitious outcome measures must be chose&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Although PASI 75 response is commonly used as the primary efficacy endpoint in clinical trials of biologics&#44; PASI 90 and even PASI 100 response rates are commonly reported and are becoming important secondary endpoints&#46; As is often the case&#44; technological&#47;therapeutic advances precede and eventually determine changes in therapeutic paradigms&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The efficacy showed by the IL-17 inhibitors &#40;both IL-17A and IL-17 receptor subunit A inhibitors&#41; in phase II and phase III clinical trials&#44; which bears the promise of achieving PASI 90 response or better in the majority of patients&#44; may make us rethink this issue again&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Methotrexate showed&#44; in the randomized controlled comparative trials of infliximab and adalimumab&#44; a 16 and 26-week PASI 90 response between 14&#8211;19&#46;1&#37; and 14&#46;9&#37;&#44; respectively&#46;<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">8&#44;9</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">Considering biologic therapy&#44; the week-12 PASI 90 rate in publish randomized trials of efalizumab&#44; one of the first biologic agents approved for psoriasis and later withdrawn&#44; was between 4&#8211;12&#37;&#44;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> while the results of a 3-year continuous dosing study&#44; showed a PASI 90 response of 24&#46;5&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">The anti-TNF&#945; therapies show better results&#44; with the monoclonal antibodies infliximab and adalimumab showing a higher response rate than the soluble TNF&#945; receptor etanercept in clinical trials&#46; In a recently published meta-analysis the efficacy of biologics in the treatment of moderate-to-severe plaque psoriasis based on the available randomized controlled trials has been estimated&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> The probability of achieving a PASI 90 response at the primary endpoint time is 19&#46;3&#37; &#40;95&#37; CI&#58; 16&#46;6&#8211;22&#46;0&#41; for etanercept at week 12&#44; 36&#46;5&#37; &#40;95&#37; CI&#58; 25&#46;7&#8211;47&#46;4&#41; for adalimumab at week 16 and 49&#46;5&#37; &#40;95&#37; CI&#58; 45&#46;6&#8211;53&#46;4&#41; for infliximab at week 10&#46; At week 24 the probability of achieving a PASI 90 response is 27&#46;8&#37; &#40;95&#37; CI&#58; 23&#46;6&#8211;31&#46;9&#41;&#44; 45&#46;7&#37; &#40;95&#37; CI&#58; 42&#46;1&#8211;49&#46;3&#41; and 50&#46;6&#37; &#40;95&#37; CI&#58; 45&#46;3&#8211;55&#46;9&#41; respectively for etanercept&#44; adalimumab and infliximab&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> In the long term&#44; the reported PASI 90 response in the open-label extension studies RESTORE and REVEAL was 45&#37; for infliximab at week 50 and 50&#37; for adalimumab at 3 years&#46;<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13&#44;14</span></a> Regarding ustekinumab&#44; the latest biologic agent approved for treatment of moderate to severe psoriasis&#44; the results observed in the phase III clinical trials were similar to the response rates observed with the anti-TNF&#945; monoclonal antibodies&#46; In the same meta-analysis&#44; the probability of achieving a PASI 90 response at week 12 and 24 is 47&#46;2&#37; &#40;95&#37; CI&#58; 42&#46;6&#8211;51&#46;8&#41; and 58&#46;2&#37; &#40;95&#37; CI&#58; 53&#46;7&#8211;62&#46;8&#41; respectively for the 45<span class="elsevierStyleHsp" style=""></span>mg dose&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> In the long-term efficacy analyze of ustekinumab in patients treated for up to 5 years in the PHOENIX 1 study&#44; the 5-year PASI 90 response rate reported was 39&#46;7&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Looking to the recently published results of phase II and phase III randomized trials of secukinumab&#44; ixekizumab &#40;both anti-IL-17A monoclonal antibodies&#41; and brodalumab &#40;anti-IL-17 receptor subunit A monoclonal antibody&#41; PASI 90 and PASI 100 response rates are impressive&#46; In the phase II&#44; randomized&#44; double-blind&#44; placebo-controlled&#44; dose-ranging study of brodalumab&#44; a PASI 90 and PASI 100 response was observed in 75&#37; and 62&#37;&#44; respectively of the patients in the 210<span class="elsevierStyleHsp" style=""></span>mg group at week 12&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> In the 48-week open-label extension of the phase II trial&#44; 86&#37; and 64&#37; of the patients achieved&#44; respectively&#44; PASI 90 and PASI 100 at week 48<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a>&#46; Concerning the phase II&#44; double-blind&#44; placebo-controlled trial with ixekizumab at 12 weeks&#44; the percentage of patients with PASI 90 and PASI 100 response was 71&#37; and 39&#37; respectively&#44; in the group of patients treated with 150<span class="elsevierStyleHsp" style=""></span>mg and 59&#37; and 38&#37; respectively in the 75<span class="elsevierStyleHsp" style=""></span>mg group&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> In the open-label extension&#44; with a dose of 120<span class="elsevierStyleHsp" style=""></span>mg every 4 week&#44; 79&#37; and 57&#37; achieved a PASI 90 and PASI 100 response after 52 weeks&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> In the phase II&#44; randomized&#44; double-blind&#44; placebo-controlled dose-ranging study of secukinumab the 12-week PASI 90 response in the 150<span class="elsevierStyleHsp" style=""></span>mg group was 52&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> In the phase III FIXTURE study&#44; comparing two doses of secukinumab &#40;300<span class="elsevierStyleHsp" style=""></span>mg and 150<span class="elsevierStyleHsp" style=""></span>mg&#41; with etanercept and placebo&#44; the 12-week PASI 90 and PASI 100 response in the 300<span class="elsevierStyleHsp" style=""></span>mg secukinumab group was 54&#37; and 24&#37; respectively&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> At week 52&#44; 65&#37; of the patients treated with secukinumab 300<span class="elsevierStyleHsp" style=""></span>mg monthly had a PASI 90 response&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> In other phase III study&#44; the ERASURE study&#44; the 12-week PASI 90 and PASI 100 response was 59&#46;2&#37; and 28&#46;6&#37; respectively&#46; At week 52&#44; nearly 60&#37; of the patients treated with secukinumab 300<span class="elsevierStyleHsp" style=""></span>mg monthly had a PASI 90 response&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">These results are in fact very promising&#44; but confirmation both from further clinical trials and particularly daily clinical practice is necessary&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">PASI 90 may represent the best meaningful clinical response&#44; instead of PASI 75&#44; particularly in patients with very severe psoriasis&#46; Considering patients with PASI above 20 &#40;as seen in most studies in moderate to severe psoriasis&#41;&#44; a PASI 75 response would associate to an absolute PASI around 5&#44; compatible with a PGA score of 2&#44; usually considered mild psoriasis &#40;mild plaque elevation&#44; light red coloration&#44; predomination of fine scale&#41;&#46; However PASI 90 response would equate to a PASI around 2&#44; compatible with a PGA of 0&#47;1 &#40;almost clear&#41;&#46; In this sense&#44; PASI 90 response probably better reflects a &#8220;clear&#8221;&#47;&#8220;almost clear&#8221; status than PASI 75&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">22</span></a> Moreover&#44; it is well known that reduction in PASI predicts a reduction in DLQI with a good correlation&#46; A recent systematic review showed that a PASI 75 response was associated with a considerably higher mean DLQI change &#40;9&#46;36&#41; than a PASI 50&#8211;75 response &#40;6&#46;12&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a> The difference between both groups was 3&#46;24&#44; higher than 3&#46;2&#44; the value considered clinically meaningful according to the proposed minimal clinically important difference for the DLQI in psoriasis&#46;<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">23&#44;24</span></a> This data suggests that there is a true quality-of-life benefit associated with higher levels of psoriasis clearance&#44; and that higher PASI reductions &#40;for instance PASI 90&#41; may probably determine even better quality-of-life benefits&#46; As a matter of fact&#44; combining data from two adalimumab trials&#44; the PASI 100 and PASI 90 to &#60;100 groups demonstrated a &#62;10-point decrease in DLQI total scores at week 16&#44; and these changes were statistically significantly greater than those observed for the PASI 75 to &#60;90 group and the other PASI response groups &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">25</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">The ultimate goal of psoriasis treatment is the complete clearance of all skin lesions and symptoms&#44; however&#44; when pushing the response rate so high&#44; safety concerns must be considered&#46; The immunomodulatory&#47;immunosuppressive effects of these agents should not be forgotten and holding the balance is the key&#46; Nevertheless the safety data on these new agents is reassuring&#44; appointing to a favorable safety profile&#46; The expected favorable safety&#47;efficacy ratio of the IL-17 inhibitors is probably related to the selective mechanism of action of these new drugs&#44; as a lower blockade in the inflammatory cascade may result in less immunosuppression and consequently in less risks of infection and malignancy&#44; while maintaining a high efficacy through selectively acting at the level of this key effector cytokine&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">26</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">The psoriasis treatment paradigm has changed with the advent of biologics&#46; The treatment advancements we have seen with these agents make us believe that achieving clearance or near-clearance of psoriasis will be possible&#46; If in the past&#44; a PASI 50 and 75 response was possibly sufficient enough and the PASI 90 achievement just a mirage&#44; maybe sooner than many expected&#44; clinicians will be disappointed if a PASI 90 response is not achieved&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interest</span><p id="par0080" class="elsevierStylePara elsevierViewall">Dr&#46; T&#46; Torres has participated in clinical trial sponsored by Abbvie&#44; Amgen and Novartis and has received honoraria for acting as a consultant and&#47;or as a speaker at events sponsored by Abbvie&#44; Janssen&#44; MSD and Pfizer&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">Prof&#46; L&#46; Puig has participated in clinical trials sponsored by Abbvie&#44; Amgen&#44; Lilly&#44; Merck&#44; Novartis&#44; Pfizer Espa&#241;a&#44; and VBL and has received honoraria for acting as a consultant and as a speaker at events sponsored by Abbvie&#44; Merck&#44; Janssen&#44; Merck&#44; Novartis&#44; and Pfizer&#46;</p></span></span>"
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Article information
ISSN: 15782190
Original language: English
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Idiomas
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