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Guidelines for the treatment of psoriatic arthritis with biologics

Guidelines for the treatment of psoriatic arthritis with biologics

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Background<br />

Psoriatic <strong>arthritis</strong> (PsA) is a chronic inflammatory arthropathy affecting up to 40% <strong>of</strong> patients <strong>with</strong> skin or nail<br />

psoriasis. It is considered a type <strong>of</strong> seronegative spondylo<strong>arthritis</strong> and can cause <strong>arthritis</strong>, en<strong>the</strong>sitis, dactylitis<br />

and axial inflammation. The use <strong>of</strong> anti‐tumour necrosis factor (TNF) <strong>the</strong>rapy <strong>for</strong> <strong>the</strong> <strong>treatment</strong> <strong>of</strong><br />

inflammatory <strong>arthritis</strong>, including PsA, has revolutionised <strong>the</strong>rapeutic options in rheumatology. The last British<br />

Society <strong>of</strong> Rheumatology (BSR) guidelines <strong>for</strong> <strong>the</strong> <strong>treatment</strong> <strong>of</strong> PsA were published in 2005 when anti‐TNF<br />

<strong>the</strong>rapy was not widely available. At that time, only one <strong>of</strong> <strong>the</strong> anti‐TNF <strong>the</strong>rapies was licensed <strong>for</strong> <strong>the</strong><br />

<strong>treatment</strong> <strong>of</strong> PsA. Since <strong>the</strong>n, use in PsA has become more widespread <strong>with</strong> multiple anti‐TNF drugs licensed<br />

<strong>for</strong> <strong>the</strong> <strong>treatment</strong> <strong>of</strong> PsA and approved <strong>for</strong> <strong>the</strong>rapy by <strong>the</strong> National Institute <strong>for</strong> Health and Clinical Excellence<br />

(NICE).<br />

However, despite <strong>the</strong>se advances, <strong>the</strong>re are still patients who do not respond to <strong>treatment</strong> <strong>with</strong> anti‐TNF<br />

<strong>the</strong>rapies and <strong>the</strong>re are difficult clinical situations where <strong>the</strong> risks <strong>of</strong> such drugs may outweigh <strong>the</strong> benefits <strong>of</strong><br />

<strong>the</strong>rapy. For this reason, it was felt that fur<strong>the</strong>r guidance was required.<br />

Need <strong>for</strong> updating <strong>of</strong> guidelines<br />

The previous guidelines <strong>for</strong> <strong>the</strong> use <strong>of</strong> anti‐TNF <strong>the</strong>rapies in PsA were published in 2005[1]. At that time, only<br />

one compound was licensed <strong>for</strong> use in active PsA in <strong>the</strong> UK (etanercept), and only one o<strong>the</strong>r anti‐TNF <strong>the</strong>rapy<br />

had evidence <strong>for</strong> <strong>the</strong> efficacy in PsA (infliximab). There are now 4 anti‐TNF drugs <strong>with</strong> proven efficacy in PsA<br />

and a number <strong>of</strong> novel compounds in development and clinical trials which may provide future <strong>the</strong>rapeutic<br />

options. There is also accumulating data from longer term use <strong>of</strong> <strong>the</strong>se <strong>the</strong>rapies to provide fur<strong>the</strong>r evidencebased<br />

recommendations <strong>for</strong> <strong>treatment</strong> choices, monitoring and safety.<br />

Objectives<br />

These guidelines <strong>of</strong>fer systematic and evidence‐based recommendations <strong>for</strong> <strong>the</strong> prescription <strong>of</strong> anti‐TNF<br />

<strong>the</strong>rapies in adult PsA patients to support UK clinicians in <strong>the</strong>ir use. The guidelines cover adult patients <strong>with</strong><br />

PsA affecting all domains <strong>of</strong> <strong>psoriatic</strong> disease. They provide a stepwise management plan giving clear advice<br />

on <strong>treatment</strong> from initial diagnosis including inclusion/exclusion criteria <strong>for</strong> <strong>treatment</strong>, monitoring<br />

requirements and how to quantify response to <strong>biologics</strong>. They provide evidence‐based advice <strong>for</strong> <strong>the</strong> use <strong>of</strong><br />

anti‐TNF <strong>the</strong>rapies in difficult situations including pregnancy and significant comorbidities. The remit <strong>of</strong> <strong>the</strong>se<br />

guidelines does not include<br />

• Biological <strong>the</strong>rapies <strong>for</strong> juvenile idiopathic <strong>arthritis</strong><br />

• Biological <strong>the</strong>rapies <strong>for</strong> patients <strong>with</strong> <strong>psoriatic</strong> disease confined to <strong>the</strong> skin<br />

Target audience<br />

The guidelines have been developed to provide assistance to rheumatologists and o<strong>the</strong>r clinicians involved in<br />

<strong>the</strong> prescription <strong>of</strong> anti‐TNF <strong>the</strong>rapies <strong>for</strong> <strong>psoriatic</strong> disease. They will also assist specialist nurses and AHPs in<br />

<strong>the</strong> application, assessment and monitoring <strong>of</strong> <strong>treatment</strong>. The guidelines have been drawn from <strong>the</strong> evidence<br />

base available following a systematic literature review up to July 2011. In areas <strong>of</strong> insufficient evidence,<br />

consensus opinion has been provided and this is clearly documented.<br />

Stakeholder involvement<br />

The guidelines have been developed by a multidisciplinary Working Party set up by <strong>the</strong> BSR including<br />

rheumatologists, dermatologists, specialist nurses and patient representatives. Any conflicts <strong>of</strong> interest among<br />

2

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