Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE
Conditions: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Psoriasis, Crohn's Disease, Ulcerative Colitis
Sponsor: AbbVie

Adalimumab
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Title Page
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NCT02750800

Adalimumab
P15-673
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Hungary - Version 1.0 (21 Oct 2015)
Page 2 of 109
Authors 
This study will be conducted in compliance with this protocol.
Confidential Information
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Marketing Authorisation Holder(s)
Marketing Authorisation Holder(s)
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1.0
Table of Contents
1.0 
Table of Contents.....................................................................3 
2.0 
Abbreviations...........................................................................5 
3.0 
Responsible Parties..................................................................8 
4.0 
Abstract ....................................................................................9 
5.0 
Amendments...........................................................................13 
6.0 
Milestones...............................................................................13 
7.0 
Rationale and Background...................................................13 
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8.0 
Research Question and Objectives ......................................19 
9.0 
Research Methods ................................................................. 20 
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Results.....................................................................................51 
13.0 
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Annex 1. 
Additional Information.........................................................57 
Appendices: patient questionnaires............................................................58 

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2.0
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Page 8 of 109
3.0
Responsible Parties
Study Designated Physician (SDP):
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3KRQH
Protocol Authors: 
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Bisotatistics and Data Management: 
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 %DODWRQIUHG 9|OJ\ VWU  +XQJDU\

Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 9 of 109
4.0
Abstract
Title: 3RVWPDUNHWLQJ REVHUYDWLRQDO VWXG\ WR HvaluDWe WKH HIIHFW RI DGDOLPXPDE WUHDWPHQW ZLWK $EE9LH¶V
SDWLHQW VXSSRUW SURJUDP RQ SDWLHQW UHSRUWHG RXWFRPHV DQG KHDOWK UHVRXUFH XWLOL]DWLRQ LQ LQIODPPDWRU\
DUWKULWLV SVRULDVLV DQG LQIODPPDWRU\ ERZHO GLVHDVHV LQ +XQJDU\ LQ D UHDOOLIH VHWWLQJ VALUE.
Rationale and Background: %LRORJLF DJHQWV KDYH UHYROXWLRQL]HG WKH WKHUDS\ RI SDWLHQWV ZLWK LPPXQH
PHGLDWHG LQIODPPDWRU\ GLVHDVHV )RUPHU DIILOLDWH QRQLQWHUYHQWLRQDO VWXG\ 1,6 UHVXOWV LQ SDWLHQWV WUHDWHG
ZLWK DGDOLPXPDE LQ 5$ DQG $6 3V DQG 3V$ LQ UHDOOLIH LQ +XQJDU\ SURYHG IDYRUDEOH UHDO OLIH
HIIHFWLYHQHVV RI DGDOLPXPDE LQ +XQJDU\ $OWKRXJK VHYHUDO UDQGRPL]HG FRQWUROOHG VWXGLHV FRQGXFWHG ZLWK
DGDOLPXPDE UHSRUW WKH HIIHFW WKH GUXJ RQ 6) 3&6 LQ YDULRXV LQGLFDWLRQV YHU\ OLPLWHG GDWD DUH DYDLODEOH
RQ WKH HIIHFW RI DGDOLPXPDE ZLWK D 363 RQ IXQFWLRQDO KHDOWK DQG ZHOOEHLQJ LQ SDWLHQWV ZLWK UKHXPDWRLG
DUWKULWLV DQN\ORVLQJ VSRQG\OLWLV SVRULDWLF DUWKULWLV SVRULDVLV &URKQ¶V GLVHDVH DQG XOFHUDWLYH FROLWLV LQ
URXWLQH FOLQLFDO VHWWLQJ LQ +XQJDU\
7UHDWPHQW DGKHUHQFH LV RI SDUWLFXODU LPSRUWDQFH LQ ,0,'V DV WKHVH DUH FKDUDFWHUL]HG E\ IOXFWXDWLQJ DQG
XVXDOO\ SURJUHVVLYH GLVHDVH FRXUVHV DQG D QHHG IRU OLIHWLPH PDQDJHPHQW
7KH JRDO RI $EE9LH SDWLHQW VXSSRUW SURJUDPV 363V LV WR RSWLPL]H WUHDWPHQW HIIHFWLYHQHVV WKURXJK D VXLWH
RI DYDLODEOH VHUYLFHV DLPLQJ DW LPSURYLQJ SDWLHQW DGKHUHQFH ([LVWLQJ HYLGHQFH ZLWK DGDOLPXPDE IURP
3$66,21 DQG 185785( VWXGLHV KDV GHPRQVWUDWHG WKDW SDWLHQW VXSSRUW SURJUDPV IRU DGDOLPXPDE DUH
DVVRFLDWHG ZLWK LPSURYHG DGKHUHQFH FOLQLFDO KHDOWK UHODWHG TXDOLW\ RI OLIH DQG HFRQRPLF RXWFRPHV
,Q +XQJDU\ D 363 KDV EHHQ FRQGXFWHG VLQFH  IRU SDWLHQWV ZLWK 5KHXPDWRORJ\ LQGLFDWLRQV $EE9LH
+XQJDU\ ZLOO EH LQ WKH SURFHVV RI LPSOHPHQWLQJ D UHYLVHG 363 $%%9,( &$5(  IURP 4 
$%%9,( &$5(  DLPV WR EXLOG RQ WKH SUHYLRXV 363 WR LPSURYH SDWLHQW¶V H[SHULHQFHV WKDW KDYH D
SRVLWLYH LPSDFW RQ SDWLHQW RXWFRPHV
Research Question and Objectives:
7KLV VWXG\ DLPV WR HYDOXDWH WKH HIIHFW RI DGDOLPXPDE ZLWK D SDWLHQW VXSSRUW SURJUDP 363 UHIHUUHG WR KHUH DV
$%%9,( &$5(  RQ FOLQLFDO KHDOWK HFRQRPLF SDWLHQWUHSRUWHG RXWFRPHV LQ SDWLHQWV ZLWK UKHXPDWRLG DUWKULWLV
DQN\ORVLQJ VSRQG\OLWLV SVRULDWLF DUWKULWLV SVRULDVLV &URKQ¶V GLVHDVH DQG XOFHUDWLYH FROLWLV LQ WKH URXWLQH FOLQLFDO
VHWWLQJ LQ +XQJDU\
Primary objective: 7R HYDOXDWH WKH LPSDFW RI DGDOLPXPDE WKHUDS\ ZLWK $%%9,( &$5(  RQ SDWLHQW IXQFWLRQDO
KHDOWK DQG ZHOOEHLQJ LQ SDWLHQWV ZLWK UKHXPDWRLG DUWKULWLV DQN\ORVLQJ VSRQG\OLWLV SVRULDWLF DUWKULWLV SVRULDVLV
&URKQ¶V GLVHDVH DQG XOFHUDWLYH FROLWLV
Secondary objectives: 

7R HYDOXDWH WKH LPSDFW RI DGDOLPXPDE WKHUDS\ SOXV $%%9,( &$5(  RQ JHQHUDO DQG GLVHDVH VSHFLILF TXDOLW\
RI OLIH 4R/ KHDOWK UHVRXUFH XWLOL]DWLRQ WUHDWPHQW VDWLVIDFWLRQ VDWLVIDFWLRQ ZLWK LQIRUPDWLRQ SURYLGHG E\ $%%9,(
&DUH  PHGLFDWLRQ DGKHUHQFH GLVHDVH DFWLYLW\ DQG ZRUN SURGXFWLYLW\

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R
SDWLHQW VRFLRGHPRJUDSKLFV
R
GLVHDVH FKDUDFWHULVWLFV
R
SDWLHQW W\SHV

(YDOXDWH WKH HIIHFW WKH H[SRVXUH WR 363 RQ SDWLHQW UHSRUWHG RXWFRPHV

Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 10 of 109
Study Design: 7KLV PXOWLFHQWHU VWXG\ ZLOO EH FRQGXFWHG LQ SURVSHFWLYH RSHQ ODEHO PXOWLFHQWHU
REVHUYDWLRQDO FRKRUW VHWWLQJ LQ +XQJDU\
Population:
x
'LDJQRVLV RI 5$ $6 3V$ 3V &' RU 8& E\ WUHDWLQJ SK\VLFLDQ
x
$JH   \HDUV DW WKH WLPH RI WKH HQUROOPHQW
x
5$ $6 3V$ 3V 8& RU &' SDWLHQWV ZKRP DGDOLPXPDE WUHDWPHQW LV LQGLFDWHG DV SHU ORFDO 6P3&
DQG SURIHVVLRQDOUHLPEXUVHPHQW JXLGHOLQHV
x
6XEMHFWV DVVLJQHG WR DGDOLPXPDE WUHDWPHQW QRW PRUH WKDQ  PRQWK SULRU WR LQFOXVLRQ
x
3DWLHQW WR ZKRP SDUWLFLSDWLRQ LQ $EE9LH &$5(  363 SURJUDP ZDV RIIHUHG DQG SDWLHQW GHFLGHG
WR MRLQ DQG KDYH VWDUWHG WKH 363
x
3DWLHQWV ZLOOLQJ WR EH LQYROYHG LQ WKH VWXG\ DQG WR VLJQ SDWLHQW LQIRUPHG FRQVHQW IRUP ,&) DQG
VXEMHFW LQIRUPDWLRQ IRUP 6,) LQ RUGHU WR DOORZ XVH DQG GLVFORVXUH RI KLVKHU SHUVRQDO KHDOWK
LQIRUPDWLRQ
Variables:
Primary endpoint: &KDQJH LQ JHQHUDO TXDOLW\ RI OLIH VFRUH 6)Y 3&6 IURP EDVHOLQH WR PRQWK 
LQ HDFK LQGLFDWLRQ
Secondary endpoints

&KDQJH LQ JHQHUDO 6)Y 0&6 VFRUHV DV ZHOO DV (4'/ TXDOLW\ RI OLIH VFRUH IURP EDVHOLQH
WR PRQWK  LQ HDFK LQGLFDWLRQ

&KDQJH LQ GLVHDVH VSHFLILF TXDOLW\ RI OLIH VFRUHV IURP EDVHOLQH WR PRQWK 
E
6,%'4 LQ FDVH RI 8& DQG &'
F
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$64R/ LQ FDVH RI $6 DQG 3V$ SDWLHQWV ZLWK D[LDO V\PSWRPV
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&KDQJHV LQ :3$,6+3 VFRUH IURP EDVHOLQH WR PRQWK  LQ HDFK LQGLFDWLRQ
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&KDQJHV LQ KHDOWK UHVRXUFH XWLOL]DWLRQ GXULQJ  PRQWKV RI DGDOLPXPDE WKHUDS\ DQG  PRQWKV
SUHFHGLQJ WKH LQWURGXFWLRQ RI DGDOLPXPDE WKHUDS\ LQ HDFK LQGLFDWLRQ DV IROORZV
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'LIIHUHQFH LQ WKH QXPEHU RI RXWSDWLHQW YLVLWV WR HDFK NLQG RI KHDOWK FDUH SURYLGHU JHQHUDO
SUDFWLWLRQHU UKHXPDWRORJLVW RWKHU VSHFLDOLVWV RSKWKDOPRORJLVW JDVWURHQWHURORJLVW GHUPDWRORJLVW
SK\VLDWULVW SK\VLRWKHUDSLVW UKHXPDWRORJ\ QXUVH WKHUDS\

&KDQJH LQ GLVHDVH DFWLYLWLHV IURP EDVHOLQH WR PRQWK 

Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 11 of 109
D
&KDQJH LQ '$6 VFRUH IURP EDVHOLQH WR PRQWK  LQ 5$ DQG SHULSKHUDO 3V$ SDWLHQWV
E
&KDQJH LQ $6'$6(65 VFRUH IURP EDVHOLQH WR PRQWK  LQ $6 DQG D[LDO 3V$ SDWLHQWV
F
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6DWLVIDFWLRQ ZLWK 363 LQ SDWLHQWV SDUWLFLSDWLQJ LQ $EE9LH &$5(  LQ HDFK LQGLFDWLRQ
 &RUUHODWLRQ EHWZHHQ SDWLHQW RXWFRPHV DQG SDWLHQW VRFLRGHPRJUDSKLFV SDWLHQW W\SH DQG
LQGLFDWLRQ
 (IIHFW RI FRQWLQXRXV XWLOL]DWLRQ RI 363 RQ SDWLHQW RXWFRPHV LQ HDFK LQGLFDWLRQ
Data Sources: 3DWLHQW FKDUWV DQG TXHVWLRQQDLUHV
Study Size: (QUROOPHQW RI  SDWLHQWV LV SODQQHG DW DSSUR[LPDWHO\  VLWHV LQ +XQJDU\
Analysis: 
Primary analysis: 
7KH SULPDU\ HQGSRLQW LV WKH FKDQJH LQ JHQHUDO TXDOLW\ RI OLIH VFRUH 6)Y 3&6 IURP EDVHOLQH WR PRQWK
 LQ HDFK LQGLFDWLRQ
Secondary analysis: 
'HVFULSWLYH VWDWLVWLFV RI WKH FKDQJH LQ JHQHUDO TXDOLW\ RI OLIH VFRUH 6)Y 3&6 IURP EDVHOLQH WR PRQWK
 ZLOO EH FDOFXODWHG LQ HDFK WKHUDSHXWLF DUHD UKHXPDWRORJ\ 5$ $6 DQG 3V$ JDVWURHQWHURORJ\ 8& DQG
&' GHUPDWRORJ\ 3V
'HVFULSWLYH VWDWLVWLFV RI FKDQJH LQ JHQHUDO TXDOLW\ RI OLIH VFRUH 6)Y 3&6 ZLOO EH FDOFXODWHG E\ SDWLHQW
W\SH
'HVFULSWLYH VWDWLVWLFV RI WKH VHFRQGDU\ YDULDEOHV ZLOO EH FDOFXODWHG E\ LQGLFDWLRQ E\ SDWLHQW W\SH DQG
WKHUDSHXWLF DUHD 'HVFULSWLYH VWDWLVWLFV ZLOO FRQWDLQ WKH QXPEHU RI FDVHV PHDQ VWDQGDUG GHYLDWLRQ 
FRQILGHQFH LQWHUYDO PLQLPXP PD[LPXP DQG PHGLDQ IRU FRQWLQXRXV YDULDEOHV DQG WKH QXPEHU RI FDVHV
DQG IUHTXHQF\ IRU FDWHJRU\ YDULDEOHV
$ PL[HG OLQHDU PRGHO ZLOO DOVR EH SHUIRUPHG RQ WKH SULPDU\ YDULDEOH FKDQJH LQ JHQHUDO TXDOLW\ RI OLIH
VFRUH 6)Y 3&6 XVLQJ LQGLFDWLRQ DQG SDWLHQW W\SH DQG WKH LQWHUDFWLRQ EHWZHHQ WUHDWPHQW LQGLFDWLRQ
DQG SDWLHQW W\SH DV IL[HG IDFWRUV WR LQYHVWLJDWH WKH HIIHFW RI SDWLHQW W\SH RQ WKH RXWFRPH 7R DGMXVW IRU
EDVHOLQH LPEDODQFHV EDVHOLQH 6)Y 3&6 VFRUHV ZLOO EH LQFOXGHG LQWR WKH PRGHO 5HVXOWLQJ SYDOXHV RI
WKH PL[HG PRGHO ZLOO EH LQWHUSUHWHG LQ D GHVFULSWLYH PDQQHU LH QR IRUPDO K\SRWKHVLV WHVWLQJ ZLOO EH
SHUIRUPHG
'HVFULSWLYH VWDWLVWLFV RI SDWLHQW RXWFRPHV ZLOO DOVR EH FDOFXODWHG E\ SDWLHQW W\SH LQGLFDWLRQ DQG VRFLR
GHPRJUDSKLF SDUDPHWHUV WR LQYHVWLJDWH WKH SRVVLEOH FRUUHODWLRQV EHWZHHQ SDWLHQW RXWFRPHV DQG WKH DERYH
IDFWRUV &RUUHODWLRQ EHWZHHQ JURXSV E\ SDWLHQW W\SH LQGLFDWLRQ VRFLRGHPRJUDSKLF SDUDPHWHUV ZLOO EH
FDOFXODWHG
(IIHFW WKH H[SRVXUH WR 363 RQ SDWLHQW RXWFRPHV ZLOO EH DQDO\]HG DSSO\LQJ PL[HG OLQHDU PRGHOV RQ WKH
SDWLHQW RXWFRPHV LQFOXGLQJ OHQJWK RI 363 XWLOL]DWLRQ LQGLFDWLRQ DV IL[HG HIIHFWV %DVHOLQH SDWLHQW RXWFRPH
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JURXSV E\ LQGLFDWLRQ.
Safety analysis: 
$OO UHFRUGHG VHULRXV DGYHUVH HYHQWV ZLOO EH OLVWHG 6$(V ZLOO EH FRGHG XVLQJ WKH 0HGLFDO 'LFWLRQDU\ IRU
5HJXODWRU\ $FWLYLWLHV 0HG'5$ DQG ZLOO EH WDEXODWHG E\ SULPDU\ 0HG'5$ V\VWHP RUJDQ FODVV 62&

Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 12 of 109
DQG SUHIHUUHG WHUP 37 )RU WUHDWPHQWV VXUJLFDO DQG PHGLFDO SURFHGXUHV WKH LQWHUQDWLRQDO QRQSURSULHWDU\
QDPH ,11 'UXJ 7HUPV DQG 3URFHGXUHV 'LFWLRQDU\ ZLOO EH XVHG
Interim analyses: 
,QWHULP DQDO\VLV RI  SDWLHQW  PRQWKV IROORZXS GDWD LV DYDLODEOH LV SODQQHG WR EH SHUIRUPHG 
Milestones:
)3)9  0DUFK 
/3/9  2FW 
&65  $XJ 

Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 13 of 109
5.0
Amendments
Number
Date
Section of Study 
Protocol
Amendment or 
Update
Reason
GG 0RQWK <<<<
7H[W
7H[W
7H[W
6.0
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7.0
Rationale and Background
7.1
Background 
%LRORJLF DJHQWV KDYH UHYROXWLRQL]HG WKH WKHUDS\ RI SDWLHQWV VXIIHULQJ IURP LPPXQH
PHGLDWHG LQIODPPDWRU\ GLVHDVHV ,0,'V 7KH DFKLHYHPHQW RI ORZ GLVHDVH DFWLYLW\ DQG
UHPLVVLRQ KDV EHFRPH D UHDOLVWLF JRDO IRU WKH SDWLHQWV 7KH FRPSOH[LWLHV LQKHUHQW WR
WUHDWPHQW DFFHSWDQFH GUXJ DGPLQLVWUDWLRQ DQG GHOLYHU\ RI VSHFLDOW\ LQMHFWDEOH GUXJV KDYH
OHG WR GHYHORSPHQW RI KLJKWRXFK SDWLHQW VXSSRUW SURJUDPV LQWHQGHG WR PD[LPL]H
WUHDWPHQW RXWFRPHV
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EHHQ HYDOXDWHG LQ VHYHUDO UDQGRPL]HG FRQWUROOHG VWXGLHV LQ YDULRXV WKHUDSHXWLF DUHDV

Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 14 of 109
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Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
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9.2
Setting
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Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
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Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
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P15-673
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Adalimumab
P15-673
Confidential Information
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Hungary - Version 1.0 (21 Oct 2015)
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Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
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Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
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Morisky Medication Adherence Scale - 4 questions
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Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 28 of 109
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P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
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9.6
Data Management 
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Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
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Page 39 of 109
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9.6.1
Endpoints
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2. Secondary endpoints
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Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
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Adalimumab
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Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 41 of 109
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9.6.2
Statistical analysis 
9.6.2.1
Primary analysis 
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EDVHOLQH WR PRQWK  LQ HDFK LQGLFDWLRQ
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9.6.2.2
Secondary analysis
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Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 42 of 109
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9.6.2.3
Safety analysis 
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9.6.2.4
Interim analyses
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DQDO\VLV

Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
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9.7
Quality Control 
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9.8
Limitations of the Research Methods
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Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
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9.9
Other Aspects
9.9.1
Investigator selection criteria
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9.9.2
Product supply
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Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 45 of 109
10.0
Protection of Human Subjects
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11.0
Management and Reporting of Complaints
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Adalimumab
P15-673
Confidential Information
No use or disclose outside AbbVie is permitted without prior written authorization from AbbVie
Hungary - Version 1.0 (21 Oct 2015)
Page 46 of 109
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11.1
Medical Complaints
11.1.1
Adverse Event Definition and Serious Adverse Event Categories
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11.1.3
Relationship to Pharmaceutical Product
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11.1.5
Serious Adverse Event Reporting
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11.1.6
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Plans for Disseminating and Communicating Study 
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13.0
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Annex 1. 
Additional Information

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Appendices: patient questionnaires
Appendix 1.
Types of patients
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1.2 RA patient classification questionnaire
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1.3 SpA patient classification questionnaire
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Appendix 2. EQ-5D-5L
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0RGHUDWHO\ 
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Physical Component Score (PCS, 0-400):………………..  
Mental Component Score (MCS, 0-400):……………… 

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Appendix 4.  SIBDQ 
Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ)
This questionnaire is designed to find out how you have been feeling during the last 2 weeks. 
You will be asked about symptoms you have been having as a result of your inflammatory 
bowel disease the way you have been feeling in general, and how your mood has been. 
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
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8.
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0F0DVWHU 8QLYHUVLW\ 7KH ,%'4 KDV EHHQ SURYLGHG XQGHU OLFHQVH IURP 0F0DVWHU 8QLYHUVLW\ DQG PXVW QRW EH FRSLHG GLVWULEXWHG RU XVHG LQ DQ\
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&RQWDFW WKH 0F0DVWHU ,QGXVWU\ /LDLVRQ 2IILFH 0,/2 IRU OLFHQVLQJ GHWDLOV HPDLO PLOR#PFPDVWHU FD
Scoring: http://tools farmacologiaclinica.info/index.php?sid=10014&lang=en&loadsecurity=67
SCORE:…………………… 

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The DLQI is calculated by summing the score of each question resulting in a maximum of 30 
and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can 
also be expressed as a percentage of the maximum possible score of 30.
**Please Note: That the scores associated with the different answers should not be printed 
on the DLQI itself, as this might cause bias**
Meaning of DLQI Scores
0-1 = no effect at all on patient’s life
2-5 = small effect on patient’s life
6-10 = moderate effect on patient’s life
11-20 = very large effect on patient’s life
21-30 = extremely large effect on patient’s life
Detailed analysis of the DLQI
The DLQI can be analysed under six headings as follows:
6HFWLRQ
4XHVWLRQV
6FRUH
Symptoms and feelings
Questions 1 and 2
Score maximum 6
Daily activities
Questions 3 and 4
Score maximum 6
Leisure
Questions 5 and 6
Score maximum 6
Work and School
Question 7
Score maximum 3
Personal relationships
Questions 8 and 9
Score maximum 6

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Treatment
Question 10
Score maximum 3
The scores for each of these sections can also be expressed as a percentage of either 6 or 3.
Interpretation of incorrectly completed questionnaires
There is a very high success rate of accurate completion of the DLQI. However, sometimes 
subjects do make mistakes.
1. If one question is left unanswered this is scored 0 and the scores are summed and 
expressed as usual out of a maximum of 30.
2. If two or more questions are left unanswered the questionnaire is not scored.
3. If question 7 is answered ‘yes’ this is scored 3. If question 7 is answered ‘no’ or ‘not 
relevant’ but then either ‘a lot’ or ‘a little’ is ticked this is then scored 2 or 1. If it is answered 
‘no’, but the second half is left incomplete, the score will remain 0. 
4. If two or more response options are ticked, the response option with the highest score 
should be recorded.
5. If there is a response between two tick boxes, the lower of the two score options should be 
recorded.
6. The DLQI can be analysed by calculating the score for each of its six sub-scales (see 
above). When using sub-scales, if the answer to one question in a sub-scale is missing, that 
sub-scale should not be scored.
Minimal Clinically Important Difference of the DLQI
In order to help the clinical interpretation of the DLQI scores a banding system (consisting of 
5 bands) has been validated. According to this system, a DLQI score 0-1 = no effect at all on 
patient’s life DLQI score of 2-5 = small effect on patient’s life, DLQI score of 6-10 = moderate
effect on patient’s life, DLQI score of  11-20 = very large effect on patient’s life, DLQI score 
of  21-30 = extremely large effect on patient’s life.
The Minimal Clinically Important Difference (MCID) of the DLQI in inflammatory skin 
diseases (range=2.2-6.9) has been estimated in 5 studies. For details please refer to the 
following article:
Basra MKA, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 
1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 
2008; 159:997-1035.

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For general inflammatory skin conditions a change in DLQI score of at least 4 points is 
considered clinically important (based on our latest published data). This means that a 
patient’s DLQI score has to either increase or decrease by at least 4 points in order to 
suggest that there has actually been a meaningful change in that patient’s quality of life since 
the previous measurement of his/her DLQI scores.

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Appendix 6. ASQoL
3OHDVH UHDG HDFK VWDWHPHQW FDUHIXOO\ :H ZRXOG OLNH \RX WR WLFN µ<HV¶ LI \RX IHHO WKH
VWDWHPHQW DSSOLHV WR \RX $QG WLFN µ1R¶ LI LW GRHV QRW 3OHDVH FKRRVH WKH UHVSRQVH WKDW
DSSOLHV EHVW WR \RX DW WKH PRPHQW
1. My condition limits the places I can go. 
<HV
1R
2. I sometimes feel like crying.
<HV
1R
3. I have difficulty dressing.
<HV
1R
4. I struggle to do jobs around the house 
<HV
1R
5. It’s impossible to sleep
<HV
1R
6. I am unable to join in activities with my friends/family
<HV
1R
7. I am tired all the time
<HV
1R

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8. I have to keep stopping what I am doing to rest 
<HV
1R
9. I have unbearable pain 
<HV
1R
10. It takes a long time to get going in the morning 
<HV
1R
11. I am unable to do jobs around the house
<HV
1R
12. I get tired easily 
<HV
1R
13. I often get frustrated 
<HV
1R
14. The pain is always there 
<HV
1R
15. I feel I miss out on a lot 
<HV
1R
16. I find it difficult to wash my hair 
<HV
1R
17. My condition gets me down 
<HV
1R
18. I worry about letting people down 
<HV
1R

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Thank you for taking the trouble to fill in this questionnaire.
Scoring:
Yes=1, No=0

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Appendix 7. TSQM-1.4 
TSQM (Version 1.4) 
Treatment Satisfaction Questionnaire for Medication
Instructions: Please take some time to think about your level of satisfaction or 
dissatisfaction with the medication you are taking in this clinical trial- We are interested 
in your evaluation of the effectiveness, side effects, and convenience of the medication 
over the last two to three weeks, or since you last used it. For each question, please place 
a single check mark next to the response that most closely corresponds to your own 
experiences.
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Appendix 8. Satisfaction with Information About Medicines Scale 
(SIMS)
Information About Medicines
:H ZRXOG OLNH WR DVN \RX DERXW the information you have received about your 
medicines 3OHDVH UDWH WKH LQIRUPDWLRQ \RX KDYH UHFHLYHG DERXW HDFK RI WKH IROORZLQJ
DVSHFWV RI \RXU PHGLFLQHV ,I \RX XVH PRUH WKDQ RQH PHGLFLQH SOHDVH JLYH \RXU RYHUDOO
IHHOLQJ DERXW LQIRUPDWLRQ \RX KDYH UHFHLYHG about all your medicines.  
Rated:
too much / too little / none received (score 0);
about right / none needed (score 1).

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««««««««««««««««««««««««««««««««««
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Total score (items 1-17):…………………….. 
Action and usage subscale (items 1-9):……………………. 
Potential problems of medication subscale (items 10-17):…………………….. 
Scores range from 0 to 17 with high scores indicating a high degree of overall satisfaction with the 
amount of medication information received.

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Appendix 9. Morisky Medication Adherence Scale – 4 questions
(MMAS-4)

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Appendix 10. Work Productivity and Activity Impairment - Specific 
Health Problem Questionnaire (WPAI-SHP)
7KH IROORZLQJ TXHVWLRQV DVN DERXW WKH HIIHFW RI \RXU 352%/(0 5KHXPDWRLG DUWKULWLV  
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 During the past seven days, how many hours did you miss from work because of 
problems associated with your RA, AS, PsA, Ps or IBD? Include hours you missed 
on sick days, times you went in late, left early, etc., because of your RA, AS, PsA, Ps 
or IBD:BBBBB +2856
 During the past seven days, how many hours did you miss from work because of 
any other reason, such as vacation, or holidays?BBBBB+2856
 During the past seven days, how many hours did you actually work? 
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Ps or IBD DIIHFWHG SURGXFWLYLW\ ZKLOH \RX ZHUH ZRUNLQJ

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WPAI Scoring
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Appendix 11. DAS28 score
'LVHDVH $FWLYLW\ ,QGH[  MRLQWV '$6 
3. ESR PPUVW KU

4. Patient’s global assessment of disease activity (0-100 mm VAS):
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How active is the disease at the moment?
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Formula for calculation of DAS28 ESR:
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DAS 28 score: 

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Appendix 12. ASDASESR score 
Calculation of ASDAS: 
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Please tick the box which represents your answer to each question. All questions refer to last week.  
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ASDAS score: ………. 

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Appendix 13. CDAI score 
Factor
Subtotal
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Appendix 15. PASI score
Psoriasis Area and Severity Index (PASI)
PASI Scoring 
Four anatomic sites - head, upper extremities, trunk, and lower extremities - are 
assessed for erythema, induration (plaque thickness) and desquamation (scaling), as 
seen on the day of the examination. The severity of each sign is assessed using a 5-
point scale: 
x 0 = No symptoms 
x
1 = Slight 
x
2 = Moderate 
x
3 = Marked 
x
4 = Very marked 
The below table outlines the characteristics of each category. 
Erythemaa
Desquamation
Induration
0 = none
No redness
No scaling
No elevation over normal skin
1 = slight
Faint redness
Fine scale, partially covering
Slight but definite elevation, 
lesions
typically edges indinstinct or
sloped
2 = moderate Red coloration
Fine to coarse scale, covering Moderate elevation with rough 
most or all of the lesions
or sloped edges
3 = marked
Very or bright red 
Coarse, non-tenacious scale
Marked elevation typically with 
coloration
predominates, covering most
hard or sharp edges
or all of the lesions
4 = very 
Extreme red 
Coarse, thick, tenacious 
Very marked elevation typically
marked
coloration; dusky to
scale over most or all 
with hard sharp edges
deep red coloration
lesions; rough surface
a. Do not include residual hyperpigmentation or hypopigmentation as erythema.

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The area affected by psoriasis within a given anatomic site is estimated as a percentage 
of the total area of that anatomic site and assigned a numerical value according to the 
degree of psoriatic involvement as follows: 
x 0 = no involvement 
x
1 = <10% 
x
2 = 10 to <30% 
x
3 = 30 to <50% 
x
4 = 50 to <70% 
x
5 = 70 to <90% 
x
6 = 90 to 100% 
Assignments for the following body regions are as follows: 
x Neck: include with the head 
x Buttocks: include with the lower extremities 
x Axillae: include with the trunk 
x GenitaIs: include with the trunk 
x The inguinal canal separates the trunk and legs anteriorly 
The PASI score for each body region is obtained by multiplying the sum of the severity 
scores by the area score, then multiplying the result by the constant weighted value 
assigned to that body region. Since the head, upper extremities, trunk, and lower 
extremities correspond to approximately 10, 20, 30, and 40% of body surface area, 
respectively, the PASI score is calculated using the formula:
PASI = 0.1 (Eh + Ih + Dh)Ah + 0.2 (Eu + lu + Du)Au + 0.3 (Et + It + Dt)At + O.4 (El + Il + Dl)Al
where E, I, D, and A denote erythema, induration, desquamation, and area, respectively, 
and h, u, t, and l denote head, upper extremities, trunk, and lower extremities, 

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respectively. PASI scores range from 0.0 to 72.0 with the highest score representing 
complete erythroderma of the severest degree. 

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Appendix 16. Feedback on ABBVIE CARE 2.0
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Ƒ , GR QRW XVH WKH VHUYLFHV
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Other educational materials:
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How would you evaluate the effectiveness of the AbbVie CARE2.0 Program? 
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