Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate

375 Pages·2017·2.05 MB·English

This is a repository copy of Certolizumab pegol and secukinumab for treating active
psoriatic arthritis following inadequate response to disease-modifying antirheumatic
drugs : a systematic review and economic evaluation.
White Rose Research Online URL for this paper:
https://eprints.whiterose.ac.uk/122272/
Version: Published Version
Article:
Corbett, Mark orcid.org/0000-0002-5937-1493, Chehadah, Fadi, Biswas, Mousumi
orcid.org/0000-0001-6781-7400 et al. (8 more authors) (2017) Certolizumab pegol and
secukinumab for treating active psoriatic arthritis following inadequate response to
disease-modifying antirheumatic drugs : a systematic review and economic evaluation.
Health technology assessment. pp. 1-326. ISSN 2046-4924
https://doi.org/10.3310/hta21560
Reuse
Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless
indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by
national copyright laws. The publisher or other rights holders may allow further reproduction and re-use of
the full text version. This is indicated by the licence information on the White Rose Research Online record
for the item.
Takedown
If you consider content in White Rose Research Online to be in breach of UK law, please notify us by
emailing [email protected] including the URL of the record and the reason for the withdrawal request.
[email protected]
https://eprints.whiterose.ac.uk/
HEALTH TECHNOLOGY ASSESSMENT
VOLUME 21 ISSUE 56 OCTOBER 2017
ISSN 1366-5278
Certolizumab pegol and secukinumab for treating
active psoriatic arthritis following inadequate
response to disease-modifying antirheumatic drugs:
a systematic review and economic evaluation
Mark Corbett, Fadi Chehadah, Mousumi Biswas, Thirimon Moe-Byrne,
Stephen Palmer, Marta Soares, Matthew Walton, Melissa Harden,
Pauline Ho, Nerys Woolacott and Laura Bojke
DOI 10.3310/hta21560

Certolizumab pegol and secukinumab for
treating active psoriatic arthritis following
inadequate response to disease-modifying
antirheumatic drugs: a systematic review
and economic evaluation
Mark Corbett,1 Fadi Chehadah,2 Mousumi Biswas,1
Thirimon Moe-Byrne,1 Stephen Palmer,2
Marta Soares,2 Matthew Walton,1 Melissa Harden,1
Pauline Ho,3 Nerys Woolacott1* and Laura Bojke2
1Centre for Reviews and Dissemination, University of York, York, UK
2Centre for Health Economics, University of York, York, UK
3The Kellgren Centre for Rheumatology, Central Manchester and Manchester
Children’s University Hospitals Trust, Manchester, UK
*Corresponding author
Declared competing interests of authors: none
Published October 2017
DOI: 10.3310/hta21560
This reportshould be referenced as follows:
Corbett M, ChehadahF, Biswas M, Moe-Byrne T, Palmer S, Soares M,etal. Certolizumab pegol
and secukinumabfor treating active psoriatic arthritis following inadequate responsetodisease-
modifying antirheumatic drugs:asystematic review and economic evaluation. HealthTechnol
Assess2017;21(56).
HealthTechnology Assessment isindexed and abstracted in IndexMedicus/MEDLINE, Excerpta
Medica/EMBASE, ScienceCitation Index Expanded (SciSearch®) andCurrent Contents®/
Clinical Medicine.

Health Technology Assessment NICETARandDAR
ISSN1366-5278(Print)
ISSN2046-4924(Online)
Impactfactor:4.236
HealthTechnologyAssessmentisindexedinMEDLINE,CINAHL,EMBASE,TheCochraneLibraryandtheClarivateAnalyticsScience
CitationIndex.
ThisjournalisamemberofandsubscribestotheprinciplesoftheCommitteeonPublicationEthics(COPE)(www.publicationethics.org/).
Editorialcontact:[email protected]
ThefullHTAarchiveisfreelyavailabletoviewonlineatwww.journalslibrary.nihr.ac.uk/hta.Print-on-demandcopiescanbepurchasedfromthe
reportpagesoftheNIHRJournalsLibrarywebsite:www.journalslibrary.nihr.ac.uk
CriteriaforinclusionintheHealthTechnologyAssessmentjournal
ReportsarepublishedinHealthTechnologyAssessment(HTA)if(1)theyhaveresultedfromworkfortheHTAprogramme,and(2)they
areofasufficientlyhighscientificqualityasassessedbythereviewersandeditors.
ReviewsinHealthTechnologyAssessmentaretermed‘systematic’whentheaccountofthesearchappraisalandsynthesismethods(to
minimisebiasesandrandomerrors)would,intheory,permitthereplicationofthereviewbyothers.
HTAprogramme
TheHTAprogramme,partoftheNationalInstituteforHealthResearch(NIHR),wassetupin1993.Itproduceshigh-qualityresearch
informationontheeffectiveness,costsandbroaderimpactofhealthtechnologiesforthosewhouse,manageandprovidecareintheNHS.
‘Healthtechnologies’arebroadlydefinedasallinterventionsusedtopromotehealth,preventandtreatdisease,andimproverehabilitation
andlong-termcare.
ThejournalisindexedinNHSEvidenceviaitsabstractsincludedinMEDLINEanditsTechnologyAssessmentReportsinformNationalInstitute
forHealthandCareExcellence(NICE)guidance.HTAresearchisalsoanimportantsourceofevidenceforNationalScreeningCommittee(NSC)
policydecisions.
FormoreinformationabouttheHTAprogrammepleasevisitthewebsite:http://www.nets.nihr.ac.uk/programmes/hta
Thisreport
TheresearchreportedinthisissueofthejournalwascommissionedandfundedbytheHTAprogrammeonbehalfofNICEasprojectnumber
15/06/04.TheprotocolwasagreedinJanuary2016.TheassessmentreportbeganeditorialreviewinSeptember2016andwasacceptedfor
publicationinMarch2017.Theauthorshavebeenwhollyresponsibleforalldatacollection,analysisandinterpretation,andforwritingup
theirwork.TheHTAeditorsandpublisherhavetriedtoensuretheaccuracyoftheauthors’reportandwouldliketothankthereviewersfor
theirconstructivecommentsonthedraftdocument.However,theydonotacceptliabilityfordamagesorlossesarisingfrommaterial
publishedinthisreport.
ThisreportpresentsindependentresearchfundedbytheNationalInstituteforHealthResearch(NIHR).Theviewsandopinionsexpressedby
authorsinthispublicationarethoseoftheauthorsanddonotnecessarilyreflectthoseoftheNHS,theNIHR,NETSCC,theHTAprogramme
ortheDepartmentofHealth.Ifthereareverbatimquotationsincludedinthispublicationtheviewsandopinionsexpressedbythe
intervieweesarethoseoftheintervieweesanddonotnecessarilyreflectthoseoftheauthors,thoseoftheNHS,theNIHR,NETSCC,theHTA
programmeortheDepartmentofHealth.
©Queen’sPrinterandControllerofHMSO2017.ThisworkwasproducedbyCorbettetal.underthetermsofacommissioning
contractissuedbytheSecretaryofStateforHealth.Thisissuemaybefreelyreproducedforthepurposesofprivateresearchand
studyandextracts(orindeed,thefullreport)maybeincludedinprofessionaljournalsprovidedthatsuitableacknowledgement
ismadeandthereproductionisnotassociatedwithanyformofadvertising.Applicationsforcommercialreproductionshouldbe
addressedto:NIHRJournalsLibrary,NationalInstituteforHealthResearch,Evaluation,TrialsandStudiesCoordinatingCentre,
AlphaHouse,UniversityofSouthamptonSciencePark,SouthamptonSO167NS,UK.
PublishedbytheNIHRJournalsLibrary(www.journalslibrary.nihr.ac.uk),producedbyPrepressProjectsLtd,Perth,Scotland
(www.prepress-projects.co.uk).
Health Technology Assessment Editor-in-Chief
Professor Hywel Williams Director, HTA Programme, UK and Foundation Professor and Co-Director of the
Centre of Evidence-Based Dermatology, University of Nottingham, UK
NIHR Journals Library Editor-in-Chief
Professor Tom Walley Director, NIHR Evaluation, Trials and Studies and Director of the EME Programme, UK
NIHR Journals Library Editors
Professor Ken Stein Chair of HTA and EME Editorial Board and Professor of Public Health,
University of Exeter Medical School, UK
Professor Andrée Le May Chair of NIHR Journals Library Editorial Group (HS&DR, PGfAR, PHR journals)
Dr Martin Ashton-Key Consultant in Public Health Medicine/Consultant Advisor, NETSCC, UK
Professor Matthias Beck Chair in Public Sector Management and Subject Leader (Management Group),
Queen’s University Management School, Queen’s University Belfast, UK
Dr Tessa Crilly Director, Crystal Blue Consulting Ltd, UK
Dr Eugenia Cronin Senior Scientific Advisor, Wessex Institute, UK
Dr Peter Davidson Director of the NIHR Dissemination Centre, University of Southampton, UK
Ms Tara Lamont Scientific Advisor, NETSCC, UK
Dr Catriona McDaid Senior Research Fellow, York Trials Unit, Department of Health Sciences,
University of York, UK
Professor William McGuire Professor of Child Health, Hull York Medical School, University of York, UK
Professor Geoffrey Meads Professor of Wellbeing Research, University of Winchester, UK
Professor John Norrie Chair in Medical Statistics, University of Edinburgh, UK
Professor John Powell Consultant Clinical Adviser, National Institute for Health and Care Excellence (NICE), UK
Professor James Raftery Professor of Health Technology Assessment, Wessex Institute, Faculty of Medicine,
University of Southampton, UK
Dr Rob Riemsma Reviews Manager, Kleijnen Systematic Reviews Ltd, UK
Professor Helen Roberts Professor of Child Health Research, UCL Institute of Child Health, UK
Professor Jonathan Ross Professor of Sexual Health and HIV, University Hospital Birmingham, UK
Professor Helen Snooks Professor of Health Services Research, Institute of Life Science, College of Medicine,
Swansea University, UK
Professor Jim Thornton Professor of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences,
University of Nottingham, UK
Professor Martin Underwood Director, Warwick Clinical Trials Unit, Warwick Medical School,
University of Warwick, UK
Please visit the website for a list of members of the NIHR Journals Library Board:
www.journalslibrary.nihr.ac.uk/about/editors
Editorial contact: [email protected]
NIHRJournalsLibrary www.journalslibrary.nihr.ac.uk
DOI:10.3310/hta21560 HEALTHTECHNOLOGYASSESSMENT2017 VOL.21 NO.56
Abstract
Certolizumab pegol and secukinumab for treating active
psoriatic arthritis following inadequate response to
disease-modifying antirheumatic drugs: a systematic
review and economic evaluation
Mark Corbett,1 Fadi Chehadah,2 Mousumi Biswas,1
Thirimon Moe-Byrne,1 Stephen Palmer,2 Marta Soares,2
Matthew Walton,1 Melissa Harden,1 Pauline Ho,3 Nerys Woolacott1*
and Laura Bojke2
1Centre forReviews andDissemination, University of York, York, UK
2Centre forHealth Economics, University ofYork, York, UK
3TheKellgren Centre for Rheumatology, CentralManchester andManchester Children’s University
Hospitals Trust, Manchester, UK
*Corresponding author [email protected]
Background: Several biologic therapies areapproved bythe National Institute for Health andCare
Excellence (NICE) for psoriatic arthritis (PsA) patients who havehad an inadequate responsetotwo or
more syntheticdisease-modifying antirheumatic drugs (DMARDs). NICE does not specifically recommend
switching from one biologic toanother, and only ustekinumab(UST; STELARA®,Janssen Pharmaceuticals,
Inc., Horsham, PA, USA) isrecommended after anti-tumour necrosis factorfailure. Secukinumab (SEC;
COSENTYX®, Novartis International AG, Basel, Switzerland) and certolizumab pegol(CZP; CIMZIA®, UCB
Pharma, Brussels, Belgium) have not previously beenappraised byNICE.
Objective: To determine theclinical effectiveness and cost-effectiveness of CZPand SEC for treating active
PsA in adultsin whom DMARDs have beeninadequately effective.
Design: Systematic review andeconomic model.
Data sources:Fourteen databases(including MEDLINE and EMBASE)were searchedfor relevant studies
from inceptionto April 2016for CZP and SEC studies; update searches wererunto identify new
comparator studies.
Review methods: Clinical effectiveness data from randomised controlled trials (RCTs) weresynthesised
using Bayesian network meta-analysis (NMA) methods to investigate the relativeefficacy ofSEC and CZP
compared with comparator therapies. Ade novomodel was developed toassessthecost-effectiveness
ofSEC and CZP compared with theother relevantcomparators. The modelwas specified for three
subpopulations, in accordance with theNICE scope (patients whohave taken one prior DMARD, patients
who have taken two ormore prior DMARDs and biologic-experienced patients). The modelswere further
classified accordingtothe level ofconcomitant psoriasis.
Results: Nineteen eligible RCTs were included inthe systematic review ofshort-term efficacy. Most studies
werewell conducted and wererated asbeing atlow riskofbias. Trials ofSEC and CZP demonstrated
clinically important efficacy in allkey clinical outcomes. At 3months, patients taking150mgofSEC
[relative risk(RR) 6.27,95%confidence interval (CI) 2.55to 15.43] orCZP (RR3.29, 95%CI 1.94 to5.56)
©Queen’sPrinterandControllerofHMSO2017.ThisworkwasproducedbyCorbettetal.underthetermsofacommissioningcontractissuedbytheSecretaryofStatefor
Health.Thisissuemaybefreelyreproducedforthepurposesofprivateresearchandstudyandextracts(orindeed,thefullreport)maybeincludedinprofessionaljournals v
providedthatsuitableacknowledgementismadeandthereproductionisnotassociatedwithanyformofadvertising.Applicationsforcommercialreproductionshouldbe
addressedto:NIHRJournalsLibrary,NationalInstituteforHealthResearch,Evaluation,TrialsandStudiesCoordinatingCentre,AlphaHouse,UniversityofSouthamptonScience
Park,SouthamptonSO167NS,UK.
ABSTRACT
were morelikely to beresponders than patientstaking placebo. TheNMA results for thebiologic-naive
subpopulations indicatedthat theeffectiveness ofSEC and CZP relative toother biologics and each other
was uncertain. Limited data wereavailable for the biologic-experienced subpopulation. Longer-term
evidence suggested that thesenewer biologics reduced diseaseprogression, with the benefitsbeing similar
tothoseseenforolderbiologics.Thedenovomodelgeneratedincrementalcost-effectivenessratios(ICERs)for
threesubpopulationsandthreepsoriasissubgroups.Insubpopulation1(biologic-naivepatientswhohadtaken
onepriorDMARD),CZPwastheoptimaltreatmentinthemoderate–severepsoriasissubgroupand150mg
ofSECwasoptimalinthesubgroupsofpatientswithmild–moderatepsoriasisornoconcomitantpsoriasis.
Insubpopulation2(biologic-naivepatientswhohadtakentwoormorepriorDMARDs),etanercept(ETN;
ENBREL®,PfizerInc.,NewYorkCity,NY,USA)islikelytobetheoptimaltreatmentinallsubgroups.TheICERs
forSECandCZPversusbestsupportivecareareintheregionof£20,000–30,000perquality-adjustedlife-year
(QALY).Insubpopulation3(biologic-experiencedpatientsorpatientsinwhombiologicsarecontraindicated),
USTislikelytobetheoptimaltreatment(ICERsareintheregionof£21,000–27,000perQALY).Theoptimal
treatmentinsubpopulation2wassensitivetothechoiceofevidencesynthesismodel.Insubpopulations2and
3,resultsweresensitivetothealgorithmforHealthAssessmentQuestionnaire-DisabilityIndexcosts.The
optimaltreatmentisnotsensitivetotheuseofbiosimilarpricesforETNandinfliximab(REMICADE®,Merck
Sharp&Dohme,Kenilworth,NJ,USA).
Conclusions: SEC and CZP may bean effective useof NHSresources, dependingon thesubpopulation
and subgroup of psoriasisseverity. There are anumberoflimitations tothis assessment, driven mainly by
data availability.
Future work: Trials areneeded toinform effectiveness of biologics in biologic-experienced populations.
Study registration: This study isregistered asPROSPERO CRD42016033357.
Funding: TheNational Institute for Health Research HealthTechnology Assessment programme.
vi
NIHRJournalsLibrary www.journalslibrary.nihr.ac.uk
DOI:10.3310/hta21560 HEALTHTECHNOLOGYASSESSMENT2017 VOL.21 NO.56
Contents
List oftables xi
List offigures xxv
Glossary xxvii
List ofabbreviations xxxiii
PlainEnglish summary xxxvii
Scientificsummary xxxix
Chapter1Background 1
Description ofhealthproblem 1
Diagnosis 1
Epidemiology 2
Measurementofdisease 2
Current service provision 3
Description ofthetechnology underassessment 4
Chapter2Definition of the decisionproblem 5
PreviousNational Institute for Health and Care Excellenceappraisals 5
Overall aims and objectives ofassessment 5
Chapter3Assessment of clinical effectiveness 7
Methodsfor reviewing clinical effectiveness 7
Search strategies 7
Inclusion criteria 7
Data extraction 9
Quality assessment 9
Methods ofdatasynthesis 10
Quantity and quality ofthe identified evidence 10
Characteristics of therandomised controlledtrials included inthe systematic review of
short-term efficacy 11
Risk-of-bias assessments 22
Short-term efficacy ofsecukinumab 22
FUTURE 2 trial 32
ERASURE andFIXTURE trials 39
CLEAR trial 40
Summary 41
Efficacy at 12–24weeks in theRAPID PsA full-trial population 46
Efficacy in the RAPID-PsA biologic-naive and biologic-experienced subgroups 46
Other efficacy results 47
Summary 48
Evaluatingthe secukinumab and certolizumab pegol trial results in comparison with
othertreatments 48
Long-term effectiveness 52
Open-label extension studies 52
©Queen’sPrinterandControllerofHMSO2017.ThisworkwasproducedbyCorbettetal.underthetermsofacommissioningcontractissuedbytheSecretaryofStatefor
Health.Thisissuemaybefreelyreproducedforthepurposesofprivateresearchandstudyandextracts(orindeed,thefullreport)maybeincludedinprofessionaljournals vii
providedthatsuitableacknowledgementismadeandthereproductionisnotassociatedwithanyformofadvertising.Applicationsforcommercialreproductionshouldbe
addressedto:NIHRJournalsLibrary,NationalInstituteforHealthResearch,Evaluation,TrialsandStudiesCoordinatingCentre,AlphaHouse,UniversityofSouthamptonScience
Park,SouthamptonSO167NS,UK.