dapsone‐ and nitroso dapsone‐specific activation of t

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Allergy. 2019;1–16. | 1 wileyonlinelibrary.com/journal/all Received: 26 September 2018 | Revised: 18 December 2018 | Accepted: 10 January 2019 DOI: 10.1111/all.13769 ORIGINAL ARTICLE Skin and Eye Diseases Dapsone‐ and nitroso dapsone‐specific activation of T cells from hypersensitive patients expressing the risk allele HLA‐B*13:01 Qing Zhao 1,2,3 | Khetam Alhilali 1 | Abdulaziz Alzahrani 1,4,5 | Mubarak Almutairi 1 | Juwaria Amjad 1 | Hong Liu 2,3 | Yonghu Sun 2,3 | Lele Sun 2,3 | Huimin Zhang 2,3 | Xiaoli Meng 1 | Andrew Gibson 1 | Monday O. Ogese 1,6 | B. Kevin Park 1 | Jianjun Liu 7 | David A. Ostrov 8 | Furen Zhang 2,3 | Dean J. Naisbitt 1 1 MRC Centre for Drug Safety Science, Department of Molecular and Clinical Pharmacology, The University of Liverpool, Liverpool, UK 2 Department of Dermatology, Shandong Provincial Hospital for Skin Disease, Shandong University, Jinan, China 3 Shandong Provincial Institute of Dermatology and Venereology, Shandong Academy of Medical Sciences, Jinan, China 4 Al Baha University, Prince Mohammad Bin Saud, Al Bahah, Saudi Arabia 5 Pharmacology Department, College of Clinical Pharmacy, AlBaha University, Al Baha, Saudi Arabia 6 Pathological Sciences, drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, UK 7 Human Genetics, Genome Institute of Singapore, A*STAR, Singapore, Singapore 8 Department of Pathology, Immunology and Laboratory Medicine, College of Medicine, University of Florida, Gainesville, Florida This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2019 The Authors. Allergy Published by John Wiley & Sons Ltd. Zhao, Alhilali and Alzahrani contributed equally to the manuscript. Abbreviations: APC, antigen‐presenting cells; DDS, dapsone; DDS‐NO, nitroso dapsone; PBMC, peripheral blood mononuclear cells; SI, stimulation index. Correspondence Dean J. Naisbitt, The University of Liverpool, Liverpool, UK. Email: [email protected] and Furen Zhang, Shandong Provincial Hospital for Skin Disease, Shandong University, Jinan, China. Email: [email protected] Funding information This work was funded by grants from the MRC (grant number MR/R009635/1), the National Key Research and Development Program of China (2016YFE0201500), the National Natural Science Foundation of China key program for international exchange and cooperation (81620108025), the National Natural Science Foundation of China (81703110, 81701579), the Key research and development program of Shandong Province (2016ZDJS07A06), the Natural Science Foundation of Shandong Abstract Background: Research into drug hypersensitivity associated with the expression of specific HLA alleles has focussed on the interaction between parent drug and the HLA with no attention given to reactive metabolites. For this reason, we have studied HLA‐B*13:01‐linked dapsone hypersensitivity to (a) explore whether the parent drug and/or nitroso metabolite activate T cells and (b) determine whether HLA‐B*13:01 is involved in the response. Methods: Peripheral blood mononuclear cells (PBMC) from six patients were cultured with dapsone and nitroso dapsone, and proliferative responses and IFN‐γ release were measured. Dapsone‐ and nitroso dapsone‐specific T‐cell clones were generated and phenotype, function, HLA allele restriction, and cross‐reactivity assessed. Dapsone intermediates were characterized by mass spectrometry. Results: Peripheral blood mononuclear cells from six patients and cloned T cells pro‐ liferated and secreted Th1/2/22 cytokines when stimulated with dapsone (clones: n = 395; 80% CD4 + CXCR3 hi CCR4 hi , 20% CD8+CXCR3 hi CCR4 hi CCR6 hi CCR9 hi CCR1

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Page 1: Dapsone‐ and nitroso dapsone‐specific activation of T

Allergy. 2019;1–16.  | 1wileyonlinelibrary.com/journal/all

Received:26September2018  |  Revised:18December2018  |  Accepted:10January2019DOI:10.1111/all.13769

O R I G I N A L A R T I C L E

Skin and Eye Diseases

Dapsone‐ and nitroso dapsone‐specific activation of T cells from hypersensitive patients expressing the risk allele HLA‐B*13:01

Qing Zhao1,2,3 | Khetam Alhilali1 | Abdulaziz Alzahrani1,4,5 | Mubarak Almutairi1 | Juwaria Amjad1 | Hong Liu2,3 | Yonghu Sun2,3 | Lele Sun2,3 | Huimin Zhang2,3 | Xiaoli Meng1 | Andrew Gibson1 | Monday O. Ogese1,6 | B. Kevin Park1 | Jianjun Liu7 | David A. Ostrov8 | Furen Zhang2,3 | Dean J. Naisbitt1

1MRCCentreforDrugSafetyScience,DepartmentofMolecularandClinicalPharmacology,TheUniversityofLiverpool,Liverpool,UK2DepartmentofDermatology,ShandongProvincialHospitalforSkinDisease,ShandongUniversity,Jinan,China3ShandongProvincialInstituteofDermatologyandVenereology,ShandongAcademyofMedicalSciences,Jinan,China4AlBahaUniversity,PrinceMohammadBinSaud,AlBahah,SaudiArabia5PharmacologyDepartment,CollegeofClinicalPharmacy,AlBahaUniversity,AlBaha,SaudiArabia6PathologicalSciences,drugSafetyandMetabolism,IMEDBiotechUnit,AstraZeneca,Cambridge,UK7HumanGenetics,GenomeInstituteofSingapore,A*STAR,Singapore,Singapore8DepartmentofPathology,ImmunologyandLaboratoryMedicine,CollegeofMedicine,UniversityofFlorida,Gainesville,Florida

ThisisanopenaccessarticleunderthetermsoftheCreativeCommonsAttributionLicense,whichpermitsuse,distributionandreproductioninanymedium,providedtheoriginalworkisproperlycited.©2019TheAuthors.AllergyPublishedbyJohnWiley&SonsLtd.

Zhao,AlhilaliandAlzahranicontributedequallytothemanuscript.

Abbreviations:APC,antigen‐presentingcells;DDS,dapsone;DDS‐NO,nitrosodapsone;PBMC,peripheralbloodmononuclearcells;SI,stimulationindex.

CorrespondenceDeanJ.Naisbitt,TheUniversityofLiverpool,Liverpool,UK.Email:[email protected],ShandongProvincialHospitalforSkinDisease,ShandongUniversity,Jinan,China.Email:[email protected]

Funding informationThisworkwasfundedbygrantsfromtheMRC(grantnumberMR/R009635/1),theNationalKeyResearchandDevelopmentProgramofChina(2016YFE0201500),theNationalNaturalScienceFoundationofChinakeyprogramforinternationalexchangeandcooperation(81620108025),theNationalNaturalScienceFoundationofChina(81703110,81701579),theKeyresearchanddevelopmentprogramofShandongProvince(2016ZDJS07A06),theNaturalScienceFoundationofShandong

AbstractBackground: ResearchintodrughypersensitivityassociatedwiththeexpressionofspecificHLAalleleshas focussedon the interactionbetweenparentdrugand theHLAwithnoattentiongiventoreactivemetabolites.Forthisreason,wehavestudiedHLA‐B*13:01‐linkeddapsonehypersensitivityto(a)explorewhethertheparentdrugand/ornitrosometaboliteactivateTcellsand(b)determinewhetherHLA‐B*13:01isinvolvedintheresponse.Methods: Peripheralbloodmononuclearcells(PBMC)fromsixpatientswereculturedwith dapsone and nitroso dapsone, and proliferative responses and IFN‐γ releaseweremeasured.Dapsone‐andnitrosodapsone‐specificT‐cellclonesweregeneratedand phenotype, function, HLA allele restriction, and cross‐reactivity assessed.Dapsoneintermediateswerecharacterizedbymassspectrometry.Results: PeripheralbloodmononuclearcellsfromsixpatientsandclonedTcellspro‐liferated and secretedTh1/2/22 cytokineswhen stimulatedwithdapsone (clones:n=395; 80%CD4+ CXCR3hiCCR4hi, 20%CD8+CXCR3hiCCR4hiCCR6hiCCR9hiCCR1

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1  | INTRODUC TION

Genome‐wideassociationstudieshave identifiedstrongassoci‐ationsbetweentheexpressionofHLAallelesandsusceptibilitytodrughypersensitivity.1Thesedatasuggestthatdrugsbindse‐lectively to theHLAprotein to activate theT cells that partic‐ipate in the adverse event. Molecular docking studies supportthis concept2,3; however,modeling data have to be interpretedwith cautionas thenatureof thedrug‐HLAprotein interactionandtherequirementforaspecificpeptideinthebindinggroovehasnotbeendetermined.Themostrobustgeneticassociationsare between HLA class I alleles and abacavir hypersensitiv‐ity,4 flucloxacillin liver injury (both HLA‐B*57:01),5 carbamaze‐pine‐induced Stevens Johnson syndrome (HLA‐B*15:02),6 and allopurinol hypersensitivity (HLA‐B*58:01),7 and in each case,mechanisticstudieshaveshownthatCD8+Tcellsareactivatedwhen the drug interacts with the relevant HLA protein.7,8 Forabacavir and carbamazepine, the drugHLAbinding site is verydifferent;abacavirbindsdeepintheHLApeptidebindingpocket,whilecarbamazepinebindstoasiteclosertotheT‐cellreceptorinterface.Despitethis,bothdrugsinteractwithHLAproteinsviaareversibleinteractiontostimulateTcells.Tcellsfrompatientswithallopurinolhypersensitivityareactivatedwithastableme‐tabolite, oxypurinol, also via a direct binding interaction withHLA.Incontrast,flucloxacillin‐specificTcellsfrompatientswithliver injury are activatedwith drug‐protein adducts, via a hap‐tenmechanisminvolvingthespontaneousbindingofthedrugtoprotein and antigen processing. This brief discussion illustratesthat rapidprogresshasbeenmade inourunderstandingof therelationshipbetweendrugHLAbindingand theactivationofTcells; however, reactive drugmetabolites have been ignored inthestudyofHLAallele‐restrictedformsofdrughypersensitivity.

Thisisprimarilybecauseoftheabsenceofsyntheticreactiveme‐tabolitesforfunctionalstudieswithTcells fromhypersensitivepatients.

Areactivemetaboliteofsulfamethoxazoleisknowntoactivatepatient T cells via a hapten mechanism12,13; however, sulfame‐thoxazolereactionsarenotassociatedwithaspecificHLAallele.Thus,werecentlysynthesizedthenitrosometaboliteofdapsoneand studied the priming of naïve T cells from healthy donors.15 Dapsonecontainsasulfonegroupthat linkstwoaromaticaminemoieties.Oxidativemetabolismof theaminegroupsgeneratesahydroxylamine. The hydroxylamine undergoes spontaneous oxi‐dationtoformnitrosodapsone,whichbindscovalentlytocellularproteins.16,17NaïveCD4+ andCD8+ T cells fromhealthy donorsareactivatedwith theparentdrugandnitrosometabolitewhenTregswereremovedandthecompoundswerepresentedbyden‐driticcells.15ThesedatashowthatbothformsofthedruginteractwithmultipleHLAmoleculesandhavethecapacitytostimulateTcellswhenregulatorypathwayshavebeenmanipulated.

Dapsone is used in combinationwith other drugs for the treat‐mentofinfectiousdiseasessuchasleprosyandmalaria.0.5%‐3.6%oftreatedpatientsdevelopahypersensitivitysyndromecharacterizedbyfever,skinrash,andinternalorganinvolvement4‐6weeksaftertreat‐mentcommences.18HLA‐B*13:01isassociatedwiththedevelopmentofdapsonehypersensitivityinChineseandThaipatients,19,20 and mod‐elingdatasuggestthatdapsonemayfitinthepeptiderecognitionsiteofHLA‐B*13:01.21Dapsone‐treatedcelllinesexpressingHLA‐B*13:01havebeenshowntoactivateTcells,whileperipheralbloodmononu‐clearcells(PBMC)from2/7patientssecretehighlevelsofthecytolyticmoleculegranulysinwhenstimulatedwiththedrug.22Despitethis,adetailedanalysisof thephenotypeandfunctionofdapsone‐specificTcellshasnotbeenperformed.Moreover,theactivationofpatientTcellswithnitrosodapsonehasnotbeeninvestigated.Thus,ourstudy

Province(JQ201616),theNationalClinicalKeyProjectofDermatologyandVenereology,theShandongProvincialAdvancedTaishanScholarConstructionProject,andtheInnovationProjectofShandongAcademyofMedicalScience.CentralfundswereobtainedfromtheMRCCentreforDrugSafetyScience(G0700654).

0hi)andnitrosodapsone(clones:n=399;78%CD4+,22%CD8+withsamechemokinereceptorprofile).CD4+andCD8+cloneswereHLAclassIIandclassIrestricted,re‐spectively, and displayed three patterns of reactivity: compound specific, weaklycross‐reactive,andstronglycross‐reactive.Nitrosodapsoneformeddimersincultureandwasreducedtodapsone,providingarationaleforthecross‐reactivity.T‐cellre‐sponsestonitrosodapsoneweredependentontheformationofacysteine‐modifiedproteinadduct,whiledapsoneinteractedinalabilemannerwithantigen‐presentingcells.CD8+clonesdisplayedanHLA‐B*13:01‐restrictedpatternofactivation.Conclusion: Thesestudiesdescribethephenotypeandfunctionofdapsone‐andni‐troso dapsone‐responsive CD4+ and CD8+ T cells from hypersensitive patients.DiscoveryofHLA‐B*13:01‐restrictedCD8+T‐cellresponsesindicatesthatdrugsandtheirreactivemetabolitesparticipateinHLAallele‐linkedformsofhypersensitivity.

K E Y W O R D S

drughypersensitivity,human,Tcells

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     |  3ZHAO et Al.

hadthreeprimaryobjectives:toinvestigatewhetherdapsoneand/ornitrosodapsoneactivatesCD4+andCD8+Tcellsfromhypersensitivepatients,todefinephenotypeandfunctionofdrug‐specificTcells,andtoexplorewhetherHLA‐B*13:01isdirectlyinvolvedinthedrug‐/drugmetabolite‐specificT‐cellresponse.

2  | METHODS

2.1 | Human subjects

Venousblood(50mL)wascollectedfrom6dapsonehypersensitivepatients.Table1summarizesthedemographicsofthepatients.TableS1showsresultsofHLAtyping.HLA‐B*13:01+donors(n=4)withnohistoryofdapsoneexposureandHLA‐B*13:01+dapsone‐toler‐antpatients(n=4)wereselectedasacontrolgroups.Patchtestingwas conductedon thebackof patientswith dapsone (0.1%‐25%).Thepatchwasremovedafter48hours.Resultswererecordedaftera further 24hours to exclude any false‐positive responses result‐ing from the patch tape. The study was approved by the EthicalCommittee of the Shandong Provincial Institute of Dermatologyand Venereology, and informed written consent was obtained. A

materialtransferagreementwassignedpriortoshipmentofPBMCtoLiverpool.

2.2 | Lymphocyte transformation test and PBMC ELIspot

Peripheral blood mononuclear cells (1.5×105cell/well) from hy‐persensitivepatientsandcontroldonorswereincubatedwithdap‐sone(125‐500µmol/L),nitrosodapsone(10‐40µmol/L),rifampicin(10‐100µmol/L), clofazimine (10‐100µmol/L), or tetanus toxoid(5 μg/mL,asapositivecontrol)inculturemediumfor5days.[3H]thy‐midinewasaddedforthefinal16hoursoftheexperiment. IFN‐γ‐secretingPBMCwere visualizedusingELIspotby culturingPBMC(5×105 cell/well)inmediumwith/withoutoptimalconcentrationsofdapsoneornitrosodapsonefor48hours.

2.3 | Generation and characterization of drug‐specific T‐cell clones

Dapsoneandnitrosodapsone‐responsiveT‐cellclonesweregener‐atedfrompatients5,6,and8byserialdilutionandcharacterizedin

G R A P H I C A L A B S T R A C TDapsoneandnitrosodapsoneactivateCD4+andCD8+Tcellsfromhypersensitivepatientsviadifferentmechanisms.DapsoneandnitrosodapsoneinteractwithHLA‐B*13:01toactivatecertainCD8+clones.Dapsonehypersensitivityshouldbeusedasanexampletosolvethestructureofdrugmetabolite‐modifiedpeptide‐HLAinteractionsandtherelationshipbetweenHLAbindingandT‐cellactivation.

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termsofcellularphenotype(CD,TCRVβ,andchemokinereceptors[flow cytometry]), secretion of cytokines and cytolytic molecules(ELIspot),antigenspecificity(dose‐responsestudiesandcross‐reac‐tivitywith structurally‐related compounds [3H]thymidine uptake]),pathwaysofactivation(antigen‐presentingcellpulsingexperiments,fixationofantigen‐presentingcellstoblockprocessing,andadditionof glutathione to block drugmetabolite protein binding), and theinvolvementofHLA‐B*13:01 intheT‐cell response (HLAantibodyblockingexperimentsanduseofpartlyHLAmatchedantigen‐pre‐sentingcells).DetailedmethodsareavailableinasDataS1.

2.4 | Statistics

All statistical analysis (one‐way ANOVA unless stated otherwise)wasperformedusingSigmaPlot12software(*P<0.05).

3  | RESULTS

3.1 | Patch testing and in vitro activation of hypersensitive patient PBMC

After 72‐hour drug exposure, 3 out of 6 patients displayed dap‐soneconcentration‐dependentpositivereadings(Figure1A).PBMCfromall3patchtest‐positivepatientswerestimulatedtoproliferate

stronglyinthepresenceofdapsoneandnitrosodapsone(Figure1B).Positivedapsone‐specificproliferativeresponses(stimulationindex[SI] 2 or above) and/or IFN‐γ secretion were also detected withPBMCfrom the3patch test‐negativepatients,whilenitrosodap‐soneresponsesweredetectedin2patients(Figure1B‐D).Ofnote,patient 7 displayed a negativenitrosodapsone lymphocyte trans‐formation test response on initial testing (Figure 1B) and a weakresponse when the assay was repeated (Figure 1D). PBMC werenot activated with the co‐medications rifampicin and clofazimine(Figure1D).PBMCfromdapsone‐naïve (SI<2)anddapsone‐toler‐ant(FigureS1)HLA‐B*13:01+controlsproliferatedinthepresenceofphytohemagglutinin,butnotthetestdrugs.

3.2 | Dapsone and nitroso dapsone activate CD4+ and CD8+ clones

A total of 1334 and 1374 CD4+ and CD8+ clones, respectively,wereexpandedfromdapsoneandnitrosodapsoneT‐celllinesfrompatients5,6, and8;626CD4+ clonesdisplayed reactivity againstdapsoneornitrosodapsone(FigureS2).Dapsone‐andnitrosodap‐sone‐specificCD8+ clonesweregenerated in lowernumbers;168wereactivatedwitheither thedrugordrugmetabolite.Dapsone‐and nitroso dapsone‐responsive CD4+ and CD8+ cloneswere de‐tectedinequalnumbers(Table2).

TA B L E 1  Patients’demographicsanddetailsofthehypersensitivityreaction

Patient ID Gender Age (years) Medication historyOnset of symptoms (days) Clinical presentation Skin patch test

1 Female 43 Dapsone,rifampin,andclofazimine

3 Fever,rash,andabnormalliverfunctiontests

3 Female 25 Dapsone,rifampin,andclofazimine

28 Fever,rash,andabnormalliverfunctiontests

5 Male 39 Dapsone,rifampin,andclofazimine

30 Fever +

6 Male 41 Dapsone,rifampin,andclofazimine.

48 Fever,rash,andlymphadenopathy +

7 Male 54 Dapsone,rifampin,andclofazimine

16 Fever,rash,andabnormalliverfunctiontests(AST47.7U/L;ALP132.3U/L)

8 Female 27 Dapsone,rifampin,andclofazimine

17 Feverandabnormalliverfunctiontests(AST56.3U/L;ALP225.7U/L;GGT184.8U/L;TBIL38.8μmol/L;DBIL21.3μmol/L;IBIL17.5)

+

F I G U R E 1  Diagnosisofdapsonehypersensitivitybyskintestingandinvitroassays.A,Skinpatchtestresultsfordapsonehypersensitivity.Skinwasexposedtodapsoneinpolyethyleneglycol200atdilutionsof0%,0.1%,0.5%,1%,5%,10%,15%,2%,and25%.Thepatchtapewaslefttotheskinfor48h,anddiagnosiswasmade24hlater.Redovalsshowareasofinflamedskin.B,Peripheralbloodmononuclearcells(PBMC)frompatientswereexposedtogradedconcentrationsofdapsoneornitrosodapsone.Proliferationwasmeasuredafter5dbytheadditionof[3H]thymidinefor16h.Resultsareexpressedasmean±SDcpmoftriplicatecultures.Adoublingofcpmindrug‐treatedculturesovervehiclecontrolisconsideredpositive.C,PBMCfrompatientswereexposedtooptimalconcentrationsofdapsoneornitrosodapsone,andIFN‐γreleasewasvisualizedbyELIspot.D,PBMCfrompatientswereexposedtogradedconcentrationsofdapsone,nitrosodapsone,rifampicin,andclofazimine.Proliferationwasmeasuredasdescribedin(B)(DDS,dapsone;DDS‐NO,nitrosodapsone;PHA,phytohaemagglutinin)

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(A)

(C)

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(B)

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One hundred and two well‐growing clones were selectedfor dose‐titration studies and the analysis of cytokine secretion.Proliferative responses were detected with 3 well‐tolerated con‐centrations of dapsone (125‐500µmol/L) and nitroso dapsone(5‐20µmol/L)anddrugtreatmentresulted in thesecretionofTh1(IFNγ),Th2(IL‐5,IL‐13),andTh22(IL‐22)cytokines,alongsidethecy‐tolyticmoleculesperforin,granzymeB,andFasL.CD4+andCD8+ clonessecretedsimilar levelsofcytokinesandcytolyticmolecules(Figure2). Table S3 shows thepercentageof dapsone (DDS)‐ andnitrosodapsone(DDS‐NO)‐responsiveCD4+andCD8+clonesthatsecreteindividualcytokines.

3.3 | Dapsone‐ and nitroso dapsone‐responsive CD4+ and CD8+ clones display three distinct patterns of cross‐reactivity

Sixty‐three dapsone‐ and 98 nitroso dapsone‐responsive CD4+ and CD8+ clones were assayed for cross‐reactivity. When all ofthedapsone‐responsivecloneswereassessed together, low levelsof proliferation were observed with nitroso dapsone (Figure 3A).Themaximumconcentrationofnitrosodapsoneusedwas10timeslowerthanthedapsoneconcentration.Analysisofindividualclonesrevealed three distinct cross‐reactivity patterns: dapsone‐spe‐cific,andweaklyandstronglycross‐reactivewithnitrosodapsone.Approximately90%oftheclonesweredapsone‐specificorweaklycross‐reactive(Figure3B,C).

NitrosodapsoneCD4+andCD8+clonesdisplayedamuchhigherlevelofcross‐reactivity (Figure3A).However,3patternsofcross‐reactivitywereagainobservedwithindividualclones:nitrosodap‐sone‐specific,andweaklyandstronglycross‐reactivewithdapsone.Incontrasttothedapsone‐responsiveclones,approximately90%ofthenitrosodapsone‐responsive cloneswerenitrosodapsone‐spe‐cificorhighlycross‐reactive(Figure3B,C).

Dapsone‐ and nitroso dapsone‐responsive clones were alsostimulated to proliferate with dapsone hydroxylamine; however,proliferative responseswere not detectedwhen cloneswere cul‐turedwith (a)dapsoneanalogueswithsubstitutions inthesulfonegroup, (b)dapsoneanalogueswithaminegroups indifferentposi‐tionsonthearomaticrings,and(c)structurallydistinctsulfonamideantimicrobials(FigureS3).

The stability of nitrosodapsone in theproliferation assaywasassessed.Nitrosodapsonewas converted rapidly to azoxydimersandtheparentcompound.Bothcompoundsweredetectablewithin10minutes. After 2days, 50% of nitroso dapsone had been con‐vertedtodapsone(Figure3D‐E).

3.4 | Cross‐reactive clones are activated with equivalent concentrations of dapsone and nitroso dapsone

Six strong and weakly cross‐reactive clones were incubated withdapsoneandnitrosodapsoneatconcentrationsof0.1‐100µmol/Ltodefinetheminimumstimulatoryconcentrationsofthetwocom‐pounds. Clones were stimulated to proliferate with equivalentconcentrations of each compound irrespective of the extent ofcross‐reactivity(Figure4).

3.5 | Dapsone‐ and nitroso dapsone‐responsive CD4+ and CD8+ clones expressing multiple TCR Vβ chains display distinct chemokine receptor profiles

Dapsone‐andnitrosodapsone‐responsiveCD4+andCD8+clonesexpressedsingle,butvariableTCRVβchains(FigureS4A),withnoclear differences discerniblewhen CD4+ and CD8+ or dapsone‐andnitrosodapsone‐responsivecloneswerecompared.Dapsone‐and nitroso dapsone‐responsive CD4+ clones expressed high

Phenotype and drug specificity

Total number of clones

Number of drug‐spe‐cific clones

Percentage of responding clones (%)

Patient8

CD4+,DDS+ 236 176 74.58

CD8+,DDS+ 245 29 11.84

CD4+,DDS‐NO+ 384 210 54.69

CD8+,DDS‐NO+ 304 54 17.76

Patient6

CD4+,DDS+ 177 76 42.94

CD8+,DDS+ 178 14 7.87

CD4+,DDS‐NO+ 208 57 27.40

CD8+,DDS‐NO+ 285 15 5.26

Patient5

CD4+,DDS+ 180 64 35.56

CD8+,DDS+ 170 36 21.18

CD4+,DDS‐NO+ 149 43 28.86

CD8+,DDS‐NO+ 192 20 10.42

TA B L E 2  PhenotypeanddrugspecificityofT‐cellclonesgeneratedfromdapsonehypersensitivepatients

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F I G U R E 2  Proliferativeresponseandcytokinereleasebydapsone‐andnitrosodapsone‐responsiveCD4+andCD8+clones.A,OnehundredandtwoCD4+orCD8+cloneswereincubatedwithautologousantigen‐presentingcellsandeitherdapsone(125‐500µmol/L)ornitrosodapsone(5‐20µmol/L)intriplicateculturesfor48h.Proliferativeresponsesweremeasuredbytheadditionof[3H]thymidine.Resultsareexpressedasmean±SDcpmoftheindicatednumberofclones.B,DetectionofIFN‐γ,IL‐5,IL‐13,IL‐17,IL‐22,granzymeB,perforin,andFas‐ligandsecretionbydapsone‐andnitrosodapsone‐responsiveCD4+andCD8+clones.Cloneswereincubatedwithautologousantigen‐presentingcells,andeitherdapsoneornitrosodapsoneandcytokinereleasewasvisualizedbyELIspot.C,RepresentativeELIspotimagesshowingthecytokinesreleasedbydapsoneandnitrosodapsone‐responsiveCD8+clones

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10

15

20

25

1 2 3 4 5 6 7 8 90

50

100

150

1 2 3 4 5 6 7 8 9

0

20

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120

1 2 3 4 5 6 7 8 90

10

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1 2 3 4 5 6 7 8 90

5

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1 2 3 4 5 6 7 8 9

0

10

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1 2 3 4 5 6 7 8 90

10

20

30

40

1 2 3 4 5 6 7 8 90

10

20

30

40

50

1 2 3 4 5 6 7 8 9

Dapsone clones

CD4+ (n = 25)

CD8+ (n = 38)

Nitroso-dapsone clones

CD4+ (n = 53)

CD8+ (n = 45)

Vehicle Dapsone Nitroso dapsone( noitarefilorPcp

mx

10–3

)( noitarefilorPcp

mx

10–3

)

Weakly cross-reactiveStrongly cross-reactive

Compound-specific

0 100 250 500 0 5 10 20

0 100 250 500 0 5 10 20

0 100 250 500 0 5 10 20 0 100 250 500 0 5 10 20 0 100 250 500 0 5 10 20

0 100 250 500 0 5 10 20 0 100 250 500 0 5 10 20 0 100 250 500 0 5 10 20

0 5 10 20 0 100 250 500 0 5 10 20 0 100 250 500 0 5 10 20 0 100 250 500

0 5 10 20 0 100 250 500 0 5 10 20 0 100 250 500 0 5 10 20 0 100 250 500

Concentration (µmol/L)

Weakly crossreactive Strongly crossreactiveCompound-specific(A) (C)(B)

0

2

4

6

8

10

12

14

16

10 min 1 h 4 h 24 h 48 h

y = 3889.7x + 23480R² = 0.9994

05

1015202530354045

0 500 1000Dapsone (µmol/L)

Daps

one

(µm

ol/L

)

Time

Peak

are

a (x

100,

000)

(E)(D)

0

1000

2000

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6000

10min

1 h 4 h 24 h 48 h

Dapsone

0

5

10

15

20

25

30

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10min

1 h 4 h 24 h 48 h

Azoxy dimer

)0001x( tnuoc noI

Page 9: Dapsone‐ and nitroso dapsone‐specific activation of T

     |  9ZHAO et Al.

levels of the chemokine receptors CXCR3 andCCR4. The CD8+ clonesexpressedCXCR3andCCR4alongsideCCR10,CCR9,andCCR6(FigureS4B).

3.6 | HLA‐restricted activation of dapsone‐ and nitroso dapsone‐responsive clones ensues via different mechanisms

Stimulation of dapsone‐ and nitroso dapsone‐responsive CD4+ and CD8+ clones was dependent on the presence of antigen‐present‐ing cells (Figure5A).Useofblockingantibodies revealed thatCD4+ and CD8+ proliferative responses to dapsone and nitroso dapsonewereHLAclass II and I restricted, respectively (Figure5B).Fixationofantigen‐presentingcellswithglutaraldehydehadnoeffectonthe

activationofCD4+orCD8+cloneswithdapsone.Incontrast,antigen‐presenting cell fixation reduced the extent of proliferationwith thenitrosometabolite (Figure6A).The residual responsedetectedwithnitrosodapsoneandfixedantigen‐presentingcellsrelatestothecon‐versionofnitrosodapsonetodapsoneinculture.

Nitroso dapsone‐responsive CD8+ clones were activated withantigen‐presentingcellspulsedwithnitrosodapsonefor0.5‐2hours(Figure6B).Twooutof4nitrosodapsone‐responsiveCD4+cloneswerealsostimulatedtoproliferatewithnitrosodapsone‐pulsedan‐tigen‐presentingcells.Antigen‐presentingcellspulsedwithdapsonefor 0.5‐2hours did not activate the dapsone‐responsive CD4+ or CD8+clones.

Figure S5A compares the level of nitroso dapsone glutathi‐oneadductsformedinthecellcultureassayinthepresenceand

F I G U R E 3  Cross‐reactivityofdapsone‐andnitrosodapsone‐responsiveT‐cellclones.Dapsone‐andnitrosodapsone‐responsiveCD4+ andCD8+cloneswereculturedwithirradiatedautologousEBV‐transformedBcellsandeitherdapsone(100‐500µmol/L)orthenitrosometabolite(5‐20µmol/L)intriplicateculturesfor48h.T‐cellproliferativeresponseswereassessedthroughtheadditionof[3H]‐thymidine.A,Meancross‐reactivitydatafor153clonesdividedaccordingtothedrugantigenperipheralbloodmononuclearcellswereculturedwithtogenerateclonesandCDphenotype.B,Piechartsshowingnumberofcloneswithaparticularcross‐reactivityprofile(compoundspecific,weeklycross‐reactive(cross‐reactivecompounddisplaying10%‐50%responsedetectedwithcomparator)andstronglycross‐reactive(cross‐reactivecompounddisplaying>50%responsedetectedwithcomparator).C,Representativeclonesdisplayingeachresponseprofile.D,Relativequantificationofdapsoneandazoxydimerinculturescontainingnitrosodapsone(30µmol/L),autologousEBV‐transformedBcells,andT‐cellclones.E,Absolutequantificationofdapsoneformationinculturescontainingnitrosodapsone(30µmol/L),autologousEBV‐transformedBcells,andT‐cellclones.Lefthandgraphshowsthestandardcurvefordapsone(concentrationrange:5nmol/L‐1µmol/L).Righthandsidegraphshowsthetime‐dependentformationofdapsone

F I G U R E 4  DapsoneandnitrosodapsoneactivateT‐cellclonesatthesameminimumconcentration.A,Dapsone‐and(B)nitrosodapsone‐responsiveCD4+andCD8+cloneswereculturedwithirradiatedautologousEBV‐transformedBcellsandeitherdapsone(0.1‐100µmol/L)orthenitrosometabolite(0.1‐100µmol/L)intriplicateculturesfor48h.T‐cellproliferativeresponseswereassessedthroughtheadditionof[3H]‐thymidine.Representativeweaklyandstronglycross‐reactivedapsoneandnitrosodapsone‐responsiveclonesareshown

0

20

40

60

0.05 0.5 5 500

1020304050

0.05 0.5 5 500

20

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0

10

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0.05 0.5 5 500

20

40

60

80

0.05 0.5 5 500

20406080

100

0.05 0.5 5 50

Dapsone clones

Nitroso-dapsone clones

Vehicle Dapsone Nitroso dapsone

( noitarefilorPcp

mx

10–3

)( noitarefilorPcp

mx

10–3

)

(A)

(B)

Clone 2 Clone 3 Clone 1

Clone 2 Clone 3 Clone 1

Concentration (µmol/L)

Concentration (µmol/L)

O

Nitroso dapsone

Dapsone

Page 10: Dapsone‐ and nitroso dapsone‐specific activation of T

10  |     ZHAO et Al.

absence of exogenous glutathione.23,24 Adducts were formedrapidly (within 2hours), and the level of adduct formationwasseveralordersofmagnitudehigherinthepresenceofexogenousglutathione.FigureS6containstracesshowinghowtheadductswerequantified.Theadditionofglutathione to theT‐cellassaycontainingsolublenitrosodapsonereducedthestrengthof theproliferative response, while the response to nitroso dapsone‐pulsed antigen‐presenting cellswas completely blocked (FigureS5B).

3.7 | Dapsone and nitroso dapsone bind with a degree of selectively to HLA‐B*13:01 to activate certain CD8+ T‐cell clones

EBV‐transformed B cells were generated from 9 healthy do‐nors expressing HLA alleles with >90% sequence homology toHLA‐B*13:01.HLAtypingofthehealthydonors isshowninTableS2. The B‐cell lines were used to explore the requirement forHLA‐B*13:01indapsone‐andnitrosodapsone‐specificCD8+T‐cell

F I G U R E 5  Antigen‐presentingcellsarerequiredfortheactivationofdapsone‐andnitrosodapsone‐responsiveCD4+andCD8+clones.A,Dapsone‐andnitrosodapsone‐responsiveCD4+ and CD8+cloneswereculturedwithdapsone(500µmol/L)orthenitrosometabolite(20µmol/L)intriplicateculturesfor48heitherinthepresenceorabsenceofautologousEBV‐transformedBcells.B,Dapsone‐andnitrosodapsone‐responsiveCD4+andCD8+cloneswereculturedwithantigen‐presentingcellsanddapsone(500µmol/L)orthenitrosometabolite(20µmol/L)intriplicateculturesfor48heitherinthepresenceorabsenceofanti‐HLAclassIandIIblockingantibodies.[3H]‐thymidinewasaddedfor16htomeasuredrug‐specificproliferativeresponses

0

20

40

60

80

100

020406080

100120

0

20

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0102030405060

0

20

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80

NO APC APC

Medium DDS 500uM

0

20

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100

Medium DDS

0

10

20

30

40

50

NO APC APC

Medium DDS-NO

0

10

20

30

Medium DDS-NO

Dapsone clones

CD8+ (n = 16)

Nitroso-dapsone clones

CD4+ (n = 20)

CD8+ (n = 22)

(A) (B)

CD4+ (n = 15)

Prol

ifera

tion

(cpm

x 10

–3)

Prol

ifera

tion

(cpm

x 10

–3)

Prol

ifera

tion

(cpm

x 10

–3)

Prol

ifera

tion

(cpm

x 10

–3)

CD8+ (n = 3)

CD4+ (n = 3)

CD8+ (n = 6)

CD4+ (n = 4)

Vehicle Dapsone Nitroso dapsone

Page 11: Dapsone‐ and nitroso dapsone‐specific activation of T

     |  11ZHAO et Al.

F I G U R E 6  DapsoneandnitrosodapsoneactivateTcellsviadifferentpathways.A,Dapsone‐andnitrosodapsone‐responsiveCD4+ and CD8+cloneswereculturedwithdapsoneorthenitrosometaboliteinthepresenceofeitherirradiatedorglutaraldehyde‐fixedautologousEBV‐transformedBcells(APC,antigen‐presentingcells)intriplicateculturesfor48h.Fixationblocksantigenprocessing.B,Dapsone‐andnitrosodapsone‐responsiveCD4+andCD8+cloneswereculturedwithdrug‐ordrugmetabolite‐pulsed(0.5‐2h)irradiatedautologousEBV‐transformedBcellsintheabsenceofsolubledrugintriplicateculturesfor48h.T‐cellproliferativeresponseswereassessedthroughtheadditionof[3H]‐thymidine

05

1015202530354045

Normal APC Fixed APC

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Normal APC Fixed APC

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10

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Normal APC Fixed APC

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60

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10

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0102030405060708090

100

0

5

10

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25

0

20

40

60

80

100

120

0

10

20

30

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0

5

10

15

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30

35

02468

1012141618

0

20

40

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100

120

0

5

10

15

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35

40

0102030405060708090

1 2 3 4 50

5

10

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30

1 2 3 4 50

102030405060708090

1 2 3 4 50

10

20

30

40

50

60

70

80

1 2 3 4 5

Dapsone clones

CD8+ (n = 16)

Nitroso-dapsone clones

CD4+ (n = 9)

CD8+ (n = 19)

(A) (B)

CD4+ (n = 8)

( noitarefilorPcp

mx

10–3

)( noitarefilorPcp

mx

10–3

)

05

101520253035404550

Control APC Fixed APCNormal

Pulsed APC (h) Pulsed APC (h) Pulsed APC (h) Pulsed APC (h)

Pulsed APC (h) Pulsed APC (h) Pulsed APC (h) Pulsed APC (h)

Vehicle Dapsone Nitroso dapsone

Prol

ifera

tion

(cpm

x 10

–3)

Prol

ifera

tion

(cpm

x 10

–3)

Clone 1 Clone 2 Clone 3 Clone 4

Clone 1 Clone 2 Clone 3 Clone 4

Clone 1 Clone 2 Clone 3 Clone 4

Clone 1 Clone 2 Clone 3 Clone 4

Page 12: Dapsone‐ and nitroso dapsone‐specific activation of T

12  |     ZHAO et Al.

activation.Autologousantigen‐presentingcellsandantigenpresent‐ingfrom1additionalpatientswereusedascomparators.

Ashas beendescribedpreviously for other drugs,25,26 30%ofdapsoneandnitrosodapsone‐responsiveHLAclassIrestrictedCD8clonesdisplayedproliferativeresponseswiththedrugormetaboliteandantigen‐presentingcellsexpressingawidevarietyofHLAalleles(resultsnot shown).Othercloneswereactivatedwith thedrugormetabolite only in the presence of autologous antigen‐presentingcells.Despitethis,30%‐40%ofCD8+clonesdisplayedadegreeofHLA‐B*13:01allelerestriction.Figure7A,Bshows3clones(1dap‐sone‐ and 2 nitroso dapsone‐responsive) that were stimulated toproliferate exclusively in thepresenceof dapsoneor nitrosodap‐sone and antigen‐presenting cells expressingHLA‐B*13:01. Threeadditional clones (1 dapsone‐ and 2 nitroso dapsone‐responsive)areshownthatwereactivatedinthepresenceofantigen‐present‐ing cells expressingHLA‐B*13:01 andeitherB*13:02,B*58:01, orB*51:01.

The2dapsone‐responsiveCD8+cloneswereexpandedinsuffi‐cientnumbersforustoconductaproliferationassayusingantigen‐presentingcellsfromthe6hypersensitivepatientsthatallexpress

HLA‐B*13:01.Thecloneswereactivatedinthepresenceofdapsoneandantigen‐presentingcellsfromallofthepatients(Figure7C).

4  | DISCUSSION

Knowledgeof theroledrugmetabolismplays inthegenerationofantigenicdeterminantsthatactivateTcellsislimited.Circumstantialevidencesupportingarolefordrugmetabolismincludestheidenti‐ficationofprotein‐reactivemetabolites formanydrugsassociatedwithahigh incidenceofhypersensitivityandthe inductionoftox‐icity intargettissuebyreactivemetabolitesandhencethepoten‐tial to disrupt immune regulatory pathways through the provisionofdangersignals.27However,themostdirectevidencelinkingdrugmetabolismtothedevelopmentofhypersensitivityisthedetectionofhalothane‐specificantibodies inpatientswith liverfailure28 and the observation that halothane protein adducts activate T cells.29 Furthermore,halothanederivativesthatformlower levelsofreac‐tivemetaboliteareassociatedwithadecreasedriskofliverinjury.30 To explorewhethermetabolites activate hypersensitive patient T

F I G U R E 7  DapsoneandnitrosodapsonebindwithadegreeofselectivelytoHLA‐B*13:01toactivatecertainCD8+T‐cellclones.A,Nitrosodapsone‐and(B)dapsone‐responsiveCD8+cloneswereculturedwithdrugordrugmetaboliteandirradiatedEBV‐transformedBcells(APC,antigen‐presentingcells)from10donorsexpressingdifferentHLA‐Ballelesintriplicateculturesfor48h.ThecompleteHLAtypeofthedifferentdonorsisshowninTableS2.C,Dapsone‐responsiveCD8+cloneswereculturedwithdapsoneandirradiatedEBV‐transformedBcellsfrom6hypersensitivepatientsexpressingHLA‐B*13:01intriplicateculturesfor48h.T‐cellproliferativeresponseswereassessedthroughtheadditionof[3H]‐thymidine

0

5

10

15

20

25

30

35

No

APC

patie

nt A

PCB*

13:0

1

B*08

:01

B*13

:02

B*15

:01

B*35

:01

B*44

:02

B*46

:01

B*51

:01

B*58

:01

0123456789

10

No

APC

Patie

nt A

PCB*

13:0

1

B*08

:01

B*13

:02

B*15

:01

B*35

:01

B*44

:02

B*46

:01

B*51

:01

B*58

:01

0

5

10

15

20

25

30

No

APC

Patie

nt A

PCB*

13:0

1

B*08

:01

B*13

:02

B*15

:01

B*35

:01

B*35

:01

B*35

:01

B*35

:01

B*35

:01

02468

1012141618

No

APC

Patie

nt A

PCB*

13:0

1

B*08

:01

B*13

:02

B*15

:01

B*35

:01

B*44

:02

B*46

:01

B*51

:01

B*58

:01

0

2

4

6

8

10

12

14

No

APC

Patie

nt A

PCB*

13:0

1

B*08

:01

B*13

:02

B*15

:01

B*35

:01

B*44

:02

B*46

:01

B*51

:01

B*58

:01

0

5

10

15

20

25

30

No

APC

Patie

nt A

PCB*

13:0

1

B*08

:01

B*13

:02

B*15

:01

B*35

:01

B*44

:02

B*46

:01

B*51

:01

B*58

:01

0

10

20

30

40

50

60

70

0

5

10

15

20

25

Nitroso dapsone clonesVehicle Dapsone Nitroso dapsone

( noitarefilorPcp

mx

10–3

)

(A)

(C)(B)

Dapsone clones

Clone 2 Clone 3 Clone 1 Clone 4

Clone 2 Clone 1 Clone 1 Clone 2

Page 13: Dapsone‐ and nitroso dapsone‐specific activation of T

     |  13ZHAO et Al.

cellsinvitro, co‐culturestrategieshavebeendevelopedusingmicro‐somal metabolite generating systems.31,32 Enhanced drug‐specificT‐cellresponseshavebeenreportedwithdrugsinthepresenceofametabolizingsystem;however,itisverydifficulttodelineatethedisparateeffectsoftheparentdrugandmetabolites.Forthisrea‐son,wesynthesizedthereactivemetaboliteofsulfamethoxazole,33 whichcausesimmune‐mediatedskinandliverreactionsthatarenotlinked to expression of a specific HLA allele.34,35Working along‐sideotherresearchers inthefieldwehaveshownthatPBMCandinflamedtissuefromallhypersensitivepatientscontainTcellsthatareactivatedwithsulfamethoxazoleand/or itsreactivemetaboliteviadifferentpathways(ie,directHLAbindingandahaptenpathway,respectively).12,13

Inrecentyears,researchersstudyinghypersensitivityreactionsstronglylinkedtoexpressionofspecificHLAalleleshavefocussedexclusively on the interaction between parent drug and the HLAmolecule.Thisisbecausetheparentdrugis,forthemostpart,theonlyreagentavailableforinvitrocellculturestudies.Theobserva‐tion thatTcells frompatientswithhypersensitivity todrugs suchascarbamazepineareactivatedwiththeparentdrug11hasleadre‐searcherstohypothesizethatreactivemetabolitesarenotinvolvedinthedevelopmentofHLAallele‐restrictedformsofdrughypersen‐sitivity.Toinvestigatethishypothesis,wenowfocusedondapsonehypersensitivityinpatientswithleprosy.Dapsoneisamodelstudydrug as hypersensitivity reactions in patients are strongly linkedto theexpressionofHLA‐B*13:01,19 the reactivenitrosometabo‐liteofdapsonehasbeensynthesizedinastableform,15 and patient samplesareavailableformechanisticstudies.UtilizingPBMCfromHLA‐B*13:01+patients,weshowCD4+andCD8+T‐cellresponsestodapsoneandthenitrosometabolite.Furthermore,dapsoneandnitrosodapsonebindtoHLA‐B*13:01toselectivelyactivatecertainCD8+clones.

Six HLA‐B*13:01+ patients that developed hypersensitivitywhile receiving dapsone in combination with rifampicin and clo‐fazimine were recruited to the study. Three displayed a positivepatch test response to dapsone. PBMC from all six patientswerestimulatedtoproliferateand/orsecreteIFN‐γafterstimulationwithdapsoneorthenitrosometabolite.Thestrongestinvitroresponseswere seen in the patients with the positive patch test response,andthesepatientswereselectedforserialdilutionexperimentstosearchfordrug‐anddrugmetabolite‐responsiveT‐cellclones.CD4+ andCD8+ subpopulationswerepurifiedbeforeplating single cellsin culture plates for the cloning procedure.Dapsone‐ and nitrosodapsone‐responsiveTcellsweregeneratedinalmostequalnumbers(dapsone395;nitrosodapsone399).Theratioofdapsone‐ornitrosodapsone‐responsiveCD4+andCD8+T‐cellcloneswas4‐5:1 inpa‐tients6and8and2:1 inpatient5,whichdemonstrates thatdrugexposureconsistentlyresults inCD4+andCD8+responsesagainstthedrugantigens.Thisisinstarkcontrasttothefindingswithabaca‐virwhereCD8+Tcellsaretheonlycellsactivatedwiththedrug.36,37 TheactivationofCD4+andCD8+clonesthatexpressedanarrayofTCRVβreceptors,withdapsoneornitrosodapsone,wasHLAclassIIandclassIrestricted,respectively.Thisconfirmsourpreviousdata

withPBMCfromhealthydonors,15whichshowsthatbothdapsoneandnitrosodapsoneinteractwithHLAclassIandclassIImolecules.

TheavailabilityofclonedCD4+andCD8+Tcellspermittedthedetailedanalysisofcross‐reactivitybetweendapsone,nitrosodap‐soneandstructurallyrelatedcompounds,mechanismsofdapsone‐andnitrosodapsone‐specificT‐cellactivation,andtheinvolvementofthealleleHLA‐B*13:01inantigenpresentation.Cross‐reactivitystudiesrevealedthatthepositionoftheaminegroupsonthearo‐maticringsofdapsoneandtheavailabilityofthesulfonegroupwascriticalfortheactivationoftheT‐cellclones.Furthermore,asapanelofsulfonamidesthatcontainonearomaticaminegroupdidnotac‐tivatetheclones,bothofdapsones’aromaticamineswererequiredforT‐cellactivation.

25%‐50%of CD4+ andCD8+ cloneswere classified as highlyspecificastheywereonlyactivatedwithonecompound(eithertheparentdrugormetabolite [Figure3B]).This confirms thatTcellsrecognizeandrespondselectivelytothetwodifferentformsofthedapsoneantigen.Dapsonehasanunusualstructureinthatthetwoaromatic amines connected to the sulfone group are identical. Ifthestructureofanitrosodapsone‐modifiedHLAbindingpeptideiscomparedwithdapsonecomplexedtothesamepeptide,itislikelythatsimilarconformationswillbeobserved,andassuch,theinter‐actionwiththeT‐cellreceptorwillbethesame.Thus,ourworkinghypothesistoexplainthedrug‐ordrugmetabolite‐specificactiva‐tionofcertainclonesisthattheHLAbindingpeptidesalsopartici‐pateintheTCRinteractionandimpartadegreeofselectivity.

When using optimum concentrations of dapsone(100‐500µmol/L) and nitroso dapsone (5‐20µmol/L) to activateCD4+ andCD8+T cells, clonesdisplayinghigh (ie, at least50%ofthe response detectedwith the opposite compound) and low (ie,10%‐50%of the responsedetectedwith theopposite compound)levelsofcross‐reactivitywerealsodetected.Themajorityofdap‐sone‐responsive, cross‐reactive CD4+ and CD8+ clones displayedlow levels of cross‐reactivity with nitroso dapsone. Using quanti‐tative mass spectrometry, we were able to demonstrate that thenitrosometaboliteisreducedtodapsoneinthe2‐dayproliferationassay.Thus,clonesincubatedwith30µmol/Lnitrosodapsonewereexposed to 2.5‐15µmol/L of the parent drug, which stimulates asuboptimalT‐cellproliferativeresponse.Incontrast,themajorityofcross‐reactive nitroso dapsone‐responsiveCD4+ andCD8+ clonesdisplayedhighlevelsofcross‐reactivitywith100‐500µmol/Ldap‐sone.Toinvestigatetheresponseprofilesfurther,apanelofcross‐reactive dapsone‐ and nitroso dapsone‐responsive clones wereculturedwithequalconcentrationsoftheparentdrugandmetabo‐lite(0.1‐100µmol/L).Interestingly,weaklyandstronglycross‐reac‐tivecloneswereactivatedwiththesameconcentrationsofdapsoneandnitrosodapsonewithsimilardose‐responsecurvesuntilnitrosometabolite‐inducedtoxicitywasdetected.Thesedataareincontrasttoourearlierstudieswithsulfamethoxazoleanditsnitrosometab‐olite,wheretheparentdrugactivatesTcellsatsignificantlyhigherconcentrations.13ItisreasonabletoassumethatHLAbindingpep‐tides play a less important role in the triggering of cross‐reactiveTCR.

Page 14: Dapsone‐ and nitroso dapsone‐specific activation of T

14  |     ZHAO et Al.

Giventhatclonesdisplayingreactivitytowarddapsoneand/orthenitrosometaboliteweredetected,itwasimportanttodefinemechanisms of antigen presentation including the requirementforantigenprocessing.Antigen‐presentingcellswererequiredforthestrongactivationofCD4+andCD8+cloneswithdapsoneandthenitrosometabolite.Cloneswereactivatedwithdapsoneinthepresenceofirradiatedandglutaraldehyde‐fixedantigen‐present‐ingcells.Incontrast,fixationreducedthestrengthofthenitrosodapsone‐specificT‐cellproliferativeresponse.ThissuggeststhatdapsoneactivatesT cells throughadirect interactionwithHLAmolecules,whereasnitrosodapsonebinds covalently to cellularproteinformingadductsthatrequireprocessingtogenerateanti‐genicpeptides.Asdiscussedabove,thebestexplanationfortheweakresponseofnitrosodapsone‐responsivecloneswithsolublenitrosodapsoneandfixedantigen‐presentingcells is theforma‐tionof dapsone in theproliferation assay. Thedrug‐specific ac‐tivation of clones fromdapsone hypersensitive patients by twopathways has important implications for the future structuralanalysisofhowdapsoneandnitrosodapsoneinteractswithHLAmolecules. Application of drug‐ or drugmetabolite‐pulsed anti‐gen‐presentingcells insteadofsolubledrug inT‐cellassayspro‐videsatooltodifferentiatebetweentheeffectsofcovalentandnon‐covalentformsofdrug.14,39Dapsone‐responsivecloneswerenot activated with dapsone‐pulsed antigen‐presenting cells. Incontrast,6outofthe8nitrosodapsone‐responsiveclonestestedwere activated with nitroso dapsone‐pulsed antigen‐presentingcellsand thestrengthof the inducedresponsewas thesameasthat seenwith theparent drug. Twoof thenitrosodapsone‐re‐sponsivecloneswerenotactivatedwithpulsedantigen‐present‐ingcells;interestingly,bothoftheseclonescross‐reactedstronglywithdapsone.

Glutathioneisatripeptideintracellularantioxidantthatprotectscells fromexposuretoaromaticnitrosocompoundsbyactingasareducingagentandthroughdirectconjugation.23,24TheadditionofglutathionetoT‐cellassayspreventsthecovalentbindingofnitrosocompounds,andhence,itispossibletoexplorewhetherTcellsareactivatedwithdrugmetabolite‐modifiedproteinadducts.40Nitrosodapsoneglutathioneadductswereformedrapidly inculturescon‐tainingthedrugmetabolite,Tcells,antigen‐presentingcells,andglu‐tathione.Moreover, glutathionedecreased the responseof clonestosolublenitrosodapsoneandblockedtheresponsetonitrosodap‐sone‐pulsedantigen‐presentingcells.Thus,theformationofacova‐lentadductbetweennitrosodapsoneandcellularproteinsisneededfortheactivationofcertainclones.

In the next section of the project, antigen‐presenting cellswere generated from healthy donors expressing HLA‐B alleleswithatleast90%sequencehomologytoHLA‐B*13:01(includinganadditionalHLA‐B*13:01+donor)toinvestigatewhethereitherdapsoneornitrosodapsone interactwithadegreeofselectivitytotheriskalleletoactivateCD8+clones.Asdescribedpreviouslywithotherformsofdrughypersensitivity,severalclonesdisplayedHLAallele‐unrestricteddrugrecognition(ie,dapsoneandnitrosodapsone stimulated a proliferative response in the presence of

multiple antigen‐presenting cells expressing differentHLA‐B al‐leles).25Other cloneswereonly activated in thepresenceofni‐trosodapsoneandautologousantigen‐presentingcells.However,a panel of clones were selectively activated with dapsone ornitroso dapsone in the presence of antigen‐presenting cells dis‐playingHLA‐B*13:01. Cross‐reactivitywas observed for severaloftheseclones;however,nopredominantTCRVβreceptorswereexpressed.This indicatesthatboththeparentdrugandreactivemetabolite interactswithHLA‐B*13:01 toactivatecertainCD8+ clones.Wearethereforesynthesizingdesignernitrosodapsone‐modified HLA‐B*13:01 binding peptides and conducting struc‐turalanalysestocomparethebindinginteractionofdapsoneandnitrosodapsonewithHLA‐B*13:01.

Different forms of drug hypersensitivity reaction are asso‐ciatedwith the secretionof a diversepanel of cytokines fromTcells.41Thus,ELIspotwasusedtoprofilecytokinesecretionfromdapsone‐andnitrosodapsone‐stimulatedclones.CD4+andCD8+ clones secreted the same panel of cytokines when stimulatedwithdapsoneornitrosodapsone,butexpresseddistinctchemo‐kine receptors. Clones secreted Th1, Th2, and Th22 cytokinesalongsidethecytolyticmoleculesperforin,granzymeB,andFasL;however,IL‐17wasnotdetected.IL‐22secretionintheabsenceofIL‐17seemstobeacommonfeatureofdrug‐specificclonesasthisprofile has now been detectedwith dapsone, sulfamethoxazole,and piperacillin.42,43 It is possible that this profile relates to thelong‐term in vitro culture of clones; thus, a future study explor‐ingthecytokineprofileinaffectedtissueswouldbeappropriate.The chemokine receptors displayedondapsone‐ or nitrosodap‐sone‐responsiveCD4+cloneswererestrictedtoCXCR3andCCR4.In contrast, CD8+ clones also expressed CCR6, 9, and 10. CCR4andCCR10havebeen implicated in themigrationofT cells intoskin44;thus,amoredetailedinvestigationofmigratorypropertiesofCD4+andCD8+Tcellsinpatientswithdapsonehypersensitivityiswarranted.

Inconclusion,ourstudyshowsthatdapsone‐andnitrosodap‐sone‐responsiveCD4+andCD8+Tcellscirculateinhypersensitivepatients.TcellswereactivatedselectivelywiththeparentdruganddrugmetaboliteviadirectHLAbindingandahaptenmechanism,re‐spectively.ThedetectionofHLA‐B*13:01‐restricteddapsone‐andnitrosodapsone‐responsiveCD8+clonesindicatesthatdapsonehy‐persensitivityshouldbeusedasanexemplartoexplorethestruc‐turalfeaturesofdrugHLAbindingandhowthisinteractionresultsinapathogenicT‐cellresponse.Forpatientswithsuspectedhyper‐sensitivity,itiscriticaltoidentifytheagentthatcausedthereaction.We are currently exploringwhether drug‐peptide antigens repre‐senteffectivereagentsforT‐cellactivation.Abetterunderstandingofdrugantigenicitywill leadtothedevelopmentof improvedevi‐dence‐baseddiagnostictools.

ACKNOWLEDG MENTS

The authors would like to thank the patients and volunteers foragreeingtodonatebloodandtissuesamples.

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CONFLIC TS OF INTERE S T

Theauthorsdeclarethattheyhavenoconflictsofinterest.

AUTHOR CONTRIBUTIONS

QZ,KA,AA,MA,JA,AG,andMOOconductedthebiologicalex‐periments. XM conducted themass spectrometric analyses.HL,LD, and HZ collected the clinical samples and conducted patchtesting.DJN, BKP,DAO, JL, and FZ designed the study and su‐pervisedtheproject.AG,MOO,XM,andDJNanalyzedthedataand drafted the manuscript. All authors critically reviewed themanuscript.

ORCID

Dean J. Naisbitt https://orcid.org/0000‐0003‐4107‐7832

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SUPPORTING INFORMATION

Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle.       

How to cite this article:ZhaoQ,AlhilaliK,AlzahraniA,etal.Dapsone‐andnitrosodapsone‐specificactivationofTcellsfromhypersensitivepatientsexpressingtheriskalleleHLA‐B*13:01.Allergy. 2019;00:1–16. https://doi.org/10.1111/all.13769