Interdisciplinary Approaches to Management of Immune-Mediated Inflammatory Diseases: Addressing Shared Pathophysiology With JAK Inhibitors

Co-Chairs and Planners Saakshi Khattri, MBBS, MD, FAAD, FACR, Marla Dubinsky, MD, Emma Guttman-Yassky, MD, PhD, and Alexis Ogdie, MD, MSCE, discuss immune-mediated inflammatory diseases in this CME/AAPA activity titled “Interdisciplinary Approaches to Management of Immune-Mediated Inflammatory Diseases: Addressing Shared Pathophysiology With JAK Inhibitors.” For the full presentation, downloadable Practice Aids, and complete CME/AAPA information, and to apply for credit, please visit us at https://bit.ly/3JhsIZ7. CME/AAPA credit will be available until April 24, 2025.

1. Interdisciplinary Approaches to Management
of Immune-Mediated Inflammatory Diseases
Addressing Shared Pathophysiology With JAK Inhibitors

‘Sakshi Khattr, MBBS, MD, FAAD, FACR Alexis Ogdie, MD, MSCE
Associate Professor ‘Associate Professor of Medicine and Epidemiology
Board Certified in Internal Medicine, Rheumatology, Perelman School of Medicine
Dermatology University of Pennsyivania
Icahn School of Medicine at Mount Sinai Philadelphia, Pennsyivania
New York, New York

Marla Dubinsky, MD
Professor of Pediatrics and Medicine Zachary Jackson
‘Chief, Division of Pediatric Gastroenterology and Nutrition Patient Actor
‘Co-Director, Susan and Leonard Feinstein IBD Cinical Center
‘Mount Sinai Kravis Children's Hospital Franklin Newton
Icahn School of Medicine, Mount Sinai New York Patient Actor
New York, New York

Gina Ostmann
Emma Guttman-Yassky, MD, PhD Patient Actor
Waldman Professor and System Chair
“The Kimberly and Eric J. Waldman Department of Dermatology Jaymirra Taylor
Director, Center of Excellence in Eczema Patient Actor
Director, Laboratory of Inflammatory Skin Diseases
Icahn School of Medicine at Mount Sinai
New York, New York

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2. Burning Questions on Immune-Mediated
Inflammatory Disease Management

‘Saakshi Khattri, MBBS, MD, FAAD, FACR Emma Guttman-Yassky, MD, PhD
Associate Professor Waldman Professor and System Chair
Board Certified in internal Medicine, The Kimberly and Eric J. Waldman Department of Dermatology
Rheumatology, Dermatology Director, Center of Excellence in Eczema
Icahn School of Medicine at Mount Sinai Director, Laboratory of inflammatory Skin Diseases.
New York, New York. Icahn School of Medicine at Mount Sinai

New York, New York

Marla Dubinsky, MD Alexis Ogdie, MD, MSCE
Professor of Pediatrics and Medicine Associate Professor of Medicine and Epidemiology
Chief, Division of Pediatric Gastroenterology and Nutrition Perelman School of Medicine
Co-Director, Susan and Leonard Feinstein IBD Clinical Center University of Pennsylvania
Mount Sinai Kravis Children's Hospital Philadelphia, Pennsylvania
Icahn School of Medicine, Mount Sinai New York

New York, New York

Go online to access full CME/AAPA information, including faculty disclosures.

Copyright €

3. The Evolving Landscape of DMARDs’

Broad-spectrum
immune modulators
(eg, gold and
sulfasalazine)

unsuccessful

(From 1998)
Cytokine blockade
opened the field:
first TNF inhibitor
approved

1975 1985 1992

19

1998

Small-molecule
drugs introduced:
JAK inhibitors

ist S1P receptor)
modulators

2005 2010 2015 2020

Methotrexate (From 1995) (From 2000) (From 2010)
ficstapproved ‘Therapeutic approaches || Early intervention | | Target range expanded:
refined, on the basis | |_ improves outcomes cytokines, cytokine
of underlying pathogenesis receptors, and
cell receptors

1. Meinnes IB, Gravallese EM. Nat Rev Immunol. 2021:21:680-886.

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4. Targets for the Management of IMIDs*

immune-mediated inflammatory diseases
RA, IBD, axial SpA, psoriasis, JIA, vasculitis, SLE, asthma,
atopic dermatitis, MS, and monogenic syndromes
—
=
sense leer yy]
targets ILATRA MINE LER NR Lag
co22 CD20 integrins IE
CD86 S1PR1
Intracellular
u oe)
Immune and stromal
cell function normalized
4. Meinnes IB, Gravallese EM. Nat Rev Immunol. 2021:21:680-686. PeerView.com

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5. ="

A

It’s All Related
Unlocking the Shared Pathophysiology
of IMIDs and Finding Drug Targets

‘Saakshi Khattri, MBBS, MD, FAAD, FACR Emma Guttman-Yassky, MD, PhD
Associate Professor Waldman Professor and System Chair
Board Certified in Internal Medicine, The Kimberly and Eric J. Waldman Department of Dermatology
Rheumatology, Dermatology Director, Center of Excellence in Eczema
Icahn School of Medicine at Mount Sinai Director, Laboratory of inflammatory Skin Diseases.
New York, New York. Icahn School of Medicine at Mount Sinai

New York, New York

Marla Dubinsky, MD Alexis Ogdie, MD, MSCE
Professor of Pediatrics and Medicine ‘Associate Professor of Medicine and Epidemiology
Chief, Division of Pediatric Gastroenterology and Nutrition Perelman School of Medicine
Co-Director, Susan and Leonard Feinstein IBD Clinical Center University of Pennsylvania
‘Mount Sinai Kravis Children's Hospital Philadelphia, Pennsylvania
Icahn School of Medicine, Mount Sinai New York

New York, New York

Go online to access full CME/AAPA information, including faculty disclosures.

Copyright ©

E
y

000-2024, PeerView

6. Dysregulated Intestinal Mucosal Immune System in IBD‘?

Normal bowel Genetic predisposition

Tight junction

— Decreased mucosal layer
(Ecazhern)

|... Abnormal microbiota

= Inflamed intestinal epithelial cells
Dysregulated tight junctions

Increased proinflammatory
f Uv’ cytokines

@-@
Treflector Treg ”,, Increased lymphocytes and
|" other immune cells
8 Disrupted effector/regulatory cell
balance (Th17/Th1 vs Treg)
1. Ramos GP, Papadakis KA. Mayo Cin Proc. 2019.4:155:15,2. Chang JT. N Engl Med 2020;383:2652 2664 PeerView.com

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7. Therapeutic Targets in IBD'

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8. Pathogenesis of AD!

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9. JAK-STAT Pathways Convey Signaling Through Cytokine
Receptors: Mechanism of Action of JAK Inhibitors’

® Cytokine ® Cytokine

Cytokine _
receptor ine

aut u
wg >

Gene Nucleus
transcription

1. Noguera Met a. Drugs. 2020,80:341-382. PeerView.com

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10. Overview of the JAK-STAT Signaling Pathways’

1. Baker KF et al Ann Rheum Dis. 2018:17:175-187.2. Gilooy K et al. ACR/ARHP 2016, Abstract FIL. 3. Jiang Letal. Bio Chem, 2008:263:28086:28073, =
4 Xe et al J Bit Chom. 2002:277:14020-14030, PeerView.com

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11. JAK Family Inhibitors FDA Approved for IMIDs1-3

co uc AD PsO PsA RA AS
Upadacitinib (selective JAK1 > JAK2) y y v y y y y
Tofacitinib (JAK1, JAK3 > JAK2) y y y
Baricitinib (JAK1, JAK2 > JAK3) y
Abrocitinib (JAK1, JAK2) vw
Ruxolitinib (cream; JAK1, JAK2 > JAK3) ve
Deucravacitinib (selective, allosteric TYK2) ya

* Approved in els with por nadequate response or Inileranc o 21 TNF Blocker? Approved in adults and pedi patents 12 years of age and older whose disease not adequate
controled wih other systemic drug products, including Blogs, or when use of those therapies ae inadvisable. © Approved or topical, shorter, noncantinuous, chronic treatment in
nonimmunocompromises adult and pediatric patents 12 years of age with disease inadequately controled wit topicalsor when those therapies ar not advisable. Approved in adults who are
Candidates for systeme therapy or phototherapy

1. Bonel Met al Ann Aheum Dis. 202483 139.160. 2. Shavky AM et al. Pharmaceutics. 2022:14:1001. 3, invog (opadacnb) Prescribing Information.

tps accessóata Ada govidrugstid, docslabel2023721187550171bLpal 4 Xejanz (act) Prescribing Information.

Nip un accessdata da govldrsgsatiso_docs/abel/2021/2032148028 2082464013 21308250031 pdf 5. Oman (bain) Prescribing Information.

ips ww accessóata da govierugsatida_docslabel2022/20792450071 pa. 6. Cibingo (abrocinb) Prescrbing Information.

‘ps accessdata da govdrogeatida_docs/abel/2023/21387 1s004bcoected pt 7. Jakaf (xl) Prescribing Information.

Nip in aczessdata da goVidrugsaida_docslabel2023/202 192502810 pa. 8. Sat (Seueravacin) Preserbing infomation m

tos New accessdat (da govidrugsatida_docs/abel2022/214958s0001 pa PeerView.com

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12. Benefits and Caveats of JAK Inhibitors’?

Benefits of JAK inhibitors Caveats of JAK inhibitor use

+ Small molecules; oral bioavailability + Some available JAK inhibitors are

PAN-JAK inhibitors, with potential
+ Simultaneous combinatorial targeting for cfftaraet effects

of cytokine receptor function;

potential to address pathophysiology Safety concerns with regard to major

of multiple IMIDs adverse cardiac events (MACE),
malignancies, venous thrombotic

Clinical trial data indicate response episodes! incteased ick otlinfection!

rates that are noninferior or even and laboratory abnormalities

superior to those achieved

with biological agents

1. Meinnes 18, Gravalese EM. Nat Rev Immunol, 2021:21:880-888. 2. Wisst Reta. Open Access Rheumatol 2024 1643-53, ER
3.Kraev K eta. Lie, 2023:132244 PeerView.com

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13. ORAL Surveillance: Trial to Investigate MACE and Cancer
Risk With Tofacitinib vs Placebo in Rheumatoid Arthritis’

Randomized, open-lab
comparing tofaci

joninferiority, postauthorization, safety end-point trial
5 mg twice daily or 10 mg twice daily to TNFi

Hazard Ratio for MACE
Comparison Hazard Ratio (95% Cl)

Tofacitinib 5 mg twice daily vs TNF inhibitor He 124 (081-191)
Tofacitinib 10 mg twice daily vs TNF inhibitor 143 0.94-2.18)
Combined tofacinitib doses vs TNF inhibitor 1.33 (0.91-1.94)
Tofacitinib 10 mg twice daily vs 4.15 (0.77-1.71)

tofacitinib 5 mg twice daily

if

0 05 1 15 2 25 3 35 4 45

Hazard Ratio for Cancers, Excluding NMSC

Comparison . Hazard Ratio (95% Cl)
Tofacitinib 5 mg twice daily vs TNF inhibitor Ll 1.47 (1.00-2.18)
Tofacitinib 10 mg twice daily vs TNF inhibitor e — 1.48 (1.00-2.19)
Combined tofacintib doses vs TNF inhibitor — 1.48 (1.04-2.09)
Tofacitinib 10 mg twice daly vs 4 1.00 (0.70-1.43)
tofacitinib 5 mg twice daily i
05 1 15 25 35 45
1. Yerberg SR et al. Eng! J Med, 2022,386:318-326, PeerView.com

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14. ORAL Surveillance: Risk of MACE by HxASCVD'

In post hoc analysis, risk of MACE was assessed in subgroups
by HxASCVD and 10-year risk of MACE, per the ASCVD-PCE calculator

IR per
Risk of MACE by HxASCVD nN AE

Tofacitinib 5 mg BID He 124 47/1455 32 091
Overall Tofacitinib 10 mg BID A 1.43 511456 35 1.05
population Combined tofacitinib doses © #—e—1 1.33 98/2911 34 0.98
TNFi una 25 0.73
Tofacitinib 5 mg BID Hi 17204 83 253
ace Tofacitinib 10 mg BID Hm 12 77 261
‘Combined tofacitinib doses AH 1.98 34/426 8.0 257
TNFi H 9/214 42 128
Tofacitinib 5 mg BID —b— 1.03 30/1,251 24 0.67

No HxASCVD H
tev risk Tofacitinib 10 mg BID te 1.25 341,234 28 0.81
factors only) Combined tofacitinib doses et 1.14 64/2485 26 0.73
TNFi AAN] MA 2 0.64

05 1 2 4 8
Hazard ratio vs TNF (08% Cl)
ze
Decreased risk with tefacinb Increased risk with tofacinib .
1. Charles-Schoeman C et al. Ann Rheum Dis. 2029,2:110-120 PeerView.com

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15. ORAL Surveillance: Risk of Safety Outcomes
With Tofacitinib vs TNF Inhibitors’

A Age 265 years or ever smoked (high risk)
ofacitnib (n = 1,895) vs TNFI(n = 926)

DD Age <65 years and never smoked (low risk)
Tofacitinib (n = 1,016) vs TNFI(n = 525)

HR vs TNFI(95% Cl) n(%) NNHvSTNFI

Risk of malignancies,
MACE, MI, VTE, and Malignancies
all-cause death was (excluding NMSC)

increased in overall study
population; prior analyses
identified age and smoking MACE,
as risk factors of interest
across safety outcomes

155(105230) 10264) 190
1.16 (0.53-2.55) 20(2) 1485

141 (0.93-2.15)
0.98 (042-231)

83 (4.4)
15(15)

a 1.92 (0.92-4.00)

0.78 (0.13-4.65)

35(1.8)
303)

Post hoc analysis aimed
to identify subpopulations

519 (186-1446) 42022)

077 (028-217) 9(09) 442
with different relative risk RSR NV E ER
Hijab eae eel a 224(120419) 55(29) 208
with tofacitinib vs TNFi All-cause death 1.05 (0.36-307) 101) 9898

by age and smoking
02% 05 1 2 4 8
A +
Favors tofacitinib Favors TNFI

* Positive NNH defined as PY of ofan exposure needed for one more paient fo report an additonal event vs TNFI Negative NNH defined as the reverse.
4. Kistensen LE et a Ann Rheum Dis. 2023;62:001-910,

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16. Show Me the Data!
A Look at the Efficacy and Safety
of JAK Inhibitors for Various IMIDs

‘Saakshi Khattri, MBBS, MD, FAAD, FACR Emma Guttman-Yassky, MD, PhD
Associate Professor Waldman Professor and System Chair
Board Certified in Internal Medicine, The Kimberly and Eric J. Waldman Department of Dermatology
Rheumatology, Dermatology Director, Center of Excellence in Eczema
Icahn School of Medicine at Mount Sinai Director, Laboratory of inflammatory Skin Diseases.
New York, New York. Icahn School of Medicine at Mount Sinai

New York, New York

Marla Dubinsky, MD Alexis Ogdie, MD, MSCE

á Professor of Pediatrics and Medicine Associate Professor of Medicine and Epidemiology
Chief, Division of Pediatric Gastroenterology and Nutrition Perelman School of Medicine
wi Co-Director, Susan and Leonard Feinstein IBD Clinical Center University of Pennsylvania

Icahn School of Medicine, Mount Sinai New York

MES our Sinai ras Chicrens Hospital Philadelphia, Pennsylvania
Ba be eles

Go online to access full CME/AAPA information, including faculty disclosures.

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17. Upadacitinib in Ulcerative Colitis?:
Clinical Remission During Induction And Maintenance!

U-ACHIEVE U-ACCOMPLISH U-ACHIEVE MAINTENANCE

Primary endpoint (week 8) Primary endpoint (week 52)

Clinical remission per adapted Mayo Score ‚Clinical remission per adapted Mayo Score”
100 100.0 400
Clinical
80 80.0 responders ee
to UPA ga
Si sm 00. A .
ite 51.9
$ 60 60.0 may © co de
El . be
5 40 40.0 33.4 # 40
= 26.0 2
20 200 È 20 12.1
45 À
o 00 0

Placebo UPA45mgQD Placebo UPA45 mg QD. Placebo UPA 15mg QD UPA 30 mg QD
+ Eigble patents were aged 1-75 years. * Adapted Mayo score 2, wth tol frequency score 1 and no rete than baste, rectal seing score of, and
endoscope subscore Si wihout Mab. <P < 001 vs placebo.

1. Danese S et al. Lancet 2022:300-2113-1128. PeerView.com

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18. Upadacitinib in Ulcerative Colitis:
AEs of Interest at Week 521

U-ACHIEVE Maintenance Treatment
Week 52

Placebo Upadacitinib 15 mg QD Upadacitinib 30 mg QD
(PY = 128.1) (PY = 198.7)
n= 245 n= 254

Serious infection 6(4) 5(3) 4(3)
Opportunistic infection

‘excluding TB or HZ 0 ut) o
Hz o 6 (4) 6 (4)
Any malignancy excluding

RUE 1(<1) 1) 2
‘Any NMSC 0 o 2(1)
Adjudicated MACE=4/CV

events ty) 9 o
Adjudicated VTE* 0 o 2(1)
Adjudicated GI perforation® 1) o 0

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Elle patients were aged16-75 years. Search criteria were based on Company MedORA Query These evens were determined onthe basis of extemal adjudication, MACE is defined
as cardiovascular death, nontatal myocardial inarcion, and nonfatal stoke. “VTE 1 dened as deep vein thvomboss and pulmonary emboism (tal and nonfat) n
1 Danese S et al Lancet 2022.309 2113-1128 PeerView.com

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19. Tofacitinib in Ulcerative Colitis?: Clinical Remission During
Induction and Maintenance and Symptomatic Response

OCTAVE 1! | OCTAVE 2! OCTAVE 1 and OCTAVE 2 OCTAVE SUSTAIN’

Primary endpaint Ean response moana ocomes ovr 2 weeks Primary andpoi (Wook 2)
Burma pa aay Ce Ser x SS Remon par ha lao Cine Seat
100 ® PBO (n=234)
100 100 en 8 Tora ome D (n = 605)
a

so so 3
* . Fu
És 60 do
€ ¿
3 3 . “os
= 40 40 La #43

5 185 39 à a

02 se
o o o
PO TOFAIOm PRO TOFAIOnG Torasms TOFA ona
So ES ÉS
COTES so eT oS MNM RIS
Days

‘Patents were 18 years fap older, "Resin: May Cai Sor 2 wh no inva subcor >1 and an RBS 10. Data om pst hoe anayes using
hry dary data fom OCTAVE 1 and OCTAVE 2 ngucton sodas °° P01 vo acebo "P< O01 pactos "Pe DS va placebo ñ
1. Sandbom Wd et al. N Engl J Med. 2017.376:1723-1736. 2. Hanauer S et al. Cin Gastroenterol Hepatol. 2019,17:130-147, PeerView.com

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20. Tofacitinib in Ulcerative Colitis?:
AEs of Interest at Week 521

OCTAVE Maintenance Treatment.
Week 52

Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
n=198 n=198 N=196

Serious infection 2 (1.0) 2 (1.0) 1 (0.5)
‘Opportunistic infection

‘excluding TB or HZ NB Ne IE
HZ 1(0.5) 3(1.5) 10(5.1)
Any malignancy excluding 4 o 0
NMSCP

Any NMSC® 1 o 3
Adjudicated MACE?/CV events o 1 1
Adjudicated VTE NR NR NR
Adjudicated GI perforation® o 0 o

Patents were 18 years of age o olde. * These evens were determined on the bass of external agjucaton. € These events were determined on the basis of the
Medical Detonary for Regulatory Actes preferred term .
1. Sandor Wd el al. N Engl J Med. 2017.376:1723-1736. PeerView.com

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21. Upadacitinib in Crohn’s Disease?: Clinical Remission
Primary Endpoint During Induction and Maintenance’

U-EXCEL U-EXCEED U-ENDURE MAINTENANCE

Primary endpoint (Week 12) Primary endpoint (Week 52)
GoM Cinea store ET ES
100 100 100

Clinical
responders
to UPA
45 mg QD +
maintenance
study

80

80

8

8

60

Patients, %

3
3
3

40

Patients, % (£95% Cl)
3

2

3

20

o o
PBO UPA4Smg CD PBO UPA45 mg QD
* Egle patents were 18.7 years of age. *CDAI cnial remission was dened as a CDA! score of ess than 150. P<, 001
1: EV Lofus Jr eta. N Engl J Med. 2023:388: 1966-1980, e
PeerView.com

PBO UPA15mgQD UPA30 mg QD

2. Rinvog (Upadaciinib) Presenbing Information, Itps www accessdata da govidrugsatida_docs/abel2023/211675s0 101 pt,

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22. Upadacitinib in Crohn’s Disease?: Safety at Week 5212

AE, n(n/100 PY) E O mg
‘AE possibly related to trial agent 135 (126.2) 135 (91.1) 139 (83.5)
AE leading to discontinuation of trial agent 8(75) 19 (128) 14 (8.4)
Death from any cause o o 0
AE of special interest
Serious infection 984) 96.1) 137.8)
ES o von 1.9
Herpes zoster infection 5(4.7) 6(4.0) 12(72)
Tuberculosis o 0 0
Adjudicated cardiovascular events o o 0
Adjudicated thrombotic events o 0 1(0.6)
Adjudicated gastrointestinal perforation 1(0.9) 107) 1(0.6)
Cancer of any type o 107) 2(12)
Excluding NMSC o 107) 2(1.2)

* Egle patents were 10-75 years of age
1. EV Lofus dr eta. N Engl J Med. 2023:388:1966-1980, 7
2 Rinvog (upadactinb) Presenbing Informatio. ntps www accessdata fda govidrugsatida_docsMabel2023/211675s0 101 pt. PeerView.com

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23. Upadacitinib in Atopic Dermatitis?: Rapid Pruritis Relief!

Measure Up 1 Measure Up 2

3
3

Upadacitinib 30 mg Upadacitinib 30 mg
80 (n= 280)

3

3

Upadacitinib 15 mg

3

(n=274)

B

From Baseline, %

* Upadacitnib 15 mg
(n=270)

8

Placebo (n = 272) Placebo (n = 274)

Proportion of Patients With 24-Point
Improvement in Weekly WP-NRS

01234567 8 9 10111213141516 0123 4 5 6 7 8 9 1011 12 13 14 15 16
Time, weeks Time, weeks

Eile patients were aged 12-75 years. PS 001 based on nominal P value. S
1. Gutiman-Yassky E etal Lancet 2021397 2151-2160. PeerView.com

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24. Upadacitinib in Atopic Dermatitis?:
Efficacy in Measure Up 1 and 2!

onary andoi | egos ata et

u — En
= 2
Eee ze
ES ae +e
22 (02274) $
gk e 5 ©
3 £9 Trace 15 m9
33 « SI. we)
5
sú FE
gE > 332
de dE,
< "024 8 TE 2% 40 3 2 024 8 2 10 © 2 = 70 A
Time, weeks Time, weeks
u oa nm = as A | m
E DD UNS mm OO
prunes ne
a etes .
4, Simpson EL et al. JAMA Dermatol, 2022:158:404-413. PeerView.com

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25. Abrocitinib in Atopic Dermatitis: Efficacy in JADE Extend’

EASI-75 IGA 0/1 PP-NRS 0/1
cs 100g Anan 20009 rs 00 mg tre 200 9 = arc 100 mg Astin 200 mg
rim "Sans Lion Tarn Lions "Time
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so m «o
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Fo do io
E E E
|. ul a.” Zo
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ES ix HA
ha E i
a »
& É é
o 03 of
REA
Time, weeks
xj pots von qu 2 pa .
A PeerView.com

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26. Upadacitinib in Atopic Dermatitis?: TEAEs Through Week 521

UPAtSma UPA om
PETITE)
oy TEAE 1288 0824) 114 108) 2402 2820) 1688 0909) 128902708) 2951 2017)
Bern 2065) son se ano) 569 ses
Mir donna zus zus sus ses ses 102
Dra A o o 103 D 160
assis
states wan new ne zus nes ses
[ cceeengioyonst peered 509) nen 1309) 1500) 509) ze
pes ur vos ven zo 269 #62 se
Act rc 102 o on o 103 109
muse 102) 308) “on so 102) “om
Conca ter an SE 269 o 202 204 308) sos
a o o o o 103 160
apte der 269 zen 269) 200 209 “os
Aust patron A o A o A A
Auca NACE 102, o 109 o ° D
Autant TE 102 o on o 102) 10)
mp EL eo JANA Dermat! 202168404413 PeerView.com

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27. Tofacitinib? and Upadacitinib? Monotherapy
in Rheumatoid Arthritis: ACR 20/50/7012

©
ls E
25 ag « 2g
: E 3 3 ” : a cs
25 33 » 28
El 55. $5
El 2 El
¿> é
E zw
E gx
2 :
2 go
é ¿ o
$ Bn
2 2

9 2 4 y
Time, weeks Time, weeks Time, weeks

of age or older. °P 5.0001 vs continued methotrexate group. P < 001. %P< 01.*P< 08. a

'N Eng J Med. 2012:367:495-507. 2. Smolen JS etal. Lancet 2010:303:2303-2311. PeerView.com

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28. Upadacitinib in Rheumatoid Arthritis?:
SELECT-MONOTHERAPY Safety Summary at Week 141

Continued Methotrexate,

‘Any AE 102 (47) 103 (47) 105 (49)
Serious AE $) 1166) 6(3)
Adverse event leading to
discontinuation of study drug ae Ee sel
Infection 57 (26) 42(19) 54 (25)

Serious infection 161) 161) o
Opportunistic infection 10) 0 31
Herpes zoster 11) 3 56)
Tuberculosis 0 0 0
Hepatic disorder 40) 40) 50)
Gastrointestinal perforation 0 0 o
Malignancy 4 (<1) 20) o
NMSC 1(<1) 0 o
Lymphoma 0 1) 0

VIE (adjudicated) 0 1(<1) o
MACE (adjudicated) 0 1) 2m
Death 0 11) 0

Iman JS ein Lancet 2102892309 2911 PeerView.com

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29. Baricitinib in Rheumatoid Arthritis?:

Safety Summary in RA-BEACON!

Weeks 0-12
Variable

Baricitinib 2 mg Dally

Baricitinib 4 mg Dally | — Placebo
(n=177) (n= 176)

Treatment exposure,

Eoin 304 206 400 658 69
Safety data, n (%)

Serious AE 7 3@) 16) m 70
Any AE after

ern 96 (65) 107 61) 11967) 11264) 123719)
withdrawal from study

rs “0 74) 96) 74) 714)
Infections 35 20) 6135) 48(27) son 76 (44)
Herpes zoster 161) 2m 4@ 2m 2m
‘Serious infections 30) 30) 3@) so 10
Cancers o o o o o
nwsc o o o o o
Major adverse a

cardiovascular event e a EN ña °
perforation o o o o o

Baricitinib 2 mg Dally,
(n= 174)

Weeks 0-24

Baricitinib 4 mg Dally
(12177)

733

18 (10)

187 (7)

16)
70 (40)
7
6a)
20
20
20

o

ates were 18 years of age o older
(Genovese MC et al. Eng J Med. 2016:374:1243-1252.

PeerView.com/VEX827

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Copyright © 2000-2024, PeerView

30. Upadacitinib in Psoriatic Arthritis?:
ACR 20 in SELECT-PsA 1 and SELECT-PsA 212

Inadequate Response or Intolerance to Previous BDMARDs

Inadequate Response or Intolerance to Previous Non-bDMARDS
ACR20 Response

100

8

Patients Achieving
ACR20, % (95% Cl)

Patents were 18 years of age or older. P 5.05 for comparison of upadactin 30 mg once per day versus placebo.

© P's.05 for comparison of upadactin 15 mg once per day versus placebo. N
1 Melnnes 18 e al Now Engl J Med. 2021384°1227-1230, 2 Mease Pet al. Ann Rheum Dis 2021:20:312-320, PeerView.com

PeerView.com/VEX827 Copyright © 2000-2024, PeerView

31. Tofacitinib in Psoriatic Arthritis?:
ACR20 in OPAL BROADEN and OPAL BEYOND‘?

Inadequate Response or Intolerance to Previous csDMARDS _ Inadequate Response or Intolerance to Previous TNFi

ACR20 Response ® Tofaeiinib 5 mg 810
100 wo
so
Tot 10 mg 810
Rn Totatins 5 mg D had Le
Aw gio pt
Sis si
2 sa 23 %
ge 0 aceso wit ich 28
¿q 0 co otcino § mg ds»
E ee „
2 so 2
o o
E 678 E EE ° 7 7 y 7 y s
Time, Time, mo

Patents were 18 year ol age or oder. * Unadjusted P < 0001 compared wi placebo. P< 05 according tothe prespecified step-down testing procedure for type | error contro within the ACR20
response time course. Unadusted P < 01 compared wih placebo. UnadjustedP 5.05 compared wih placebo. P05 compared with placebo for bal type 1 error cont,

“accoróng tothe prespecified sep-down tesing procedure nee.
F'Mease Petal N Eng J Med. 2017.377:1537-1880, 2. Gladman D et al N Eng J Med. 2017:377:1525-1598 PeerView.com

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32. Upadacitinib in Axial Spondyloarthritis?:
ASAS 40 at Week 14 in SELECT-Axis 212

Radiographic axSpA Nonradiographic axSpA
Inadequate Response or Intolerance to 22 NSAIDs and Inadequate Response or Intolerance to 22 NSAIDs and
Inadequate Response to bDMARD Therapy Inadequate Response to One bDMARD in 33%

3

so 1
so H
® = 1
E = 70 t
z
E Zo
$ Es
5 patectn 15 m0
E de
Tpadacin 15 m9 Bn
QD (n= 211), &
“m
13__(n=209) - vo
o
Sir 4 H De
Time, weeks Time, weeks .
Patents were 18 years of geo er. P< 05; P oblaned tough Nominal es. <P 2 A00 P bla rag nominal sate estr Frees
Poot, agitan muay conroto ana, 7
1. Van der Heide D et al. Ann Rheum Dis, 2022:81: 1515-1523, 2. Van den Bosch F et al. Ann Rheum Dis. 2023:82(Suppl 1}361.362. PeerView.com

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33. My Patient Has at Least One IMID
How Do | Customize Their Treatment?

Alexis Ogdie, MD, MSCE
Associate Professor Associate Professor of Medicine and Epidemiology
Perelman School of Medicine

University of Pennsyivania
Philadelphia, Pennsyivania

‘Sakshi Khattr, MBBS, MD, FAAD, FACR

Board Certified in Internal Medicine, Rheumatology,
Dermatology

lcahn School of Medicine at Mount Sinai

New York, New York

Marla Dubinsky, MD
Professor of Pediatrics and Medicine

(Chief, Division of Pediatric Gastroenterology and Nutrtion
Co-Director, Susan and Leonard Feinstein IBD Cinical Center
Mount Sinai Kravis Children's Hospital

cahn Schoo! of Medicine, Mount Sinai New York

New York, New York

Emma Guttman-Yassky, MD, PhO
Waldman Professor and System Chair

“The Kimberly and Eric J. Waldman Department of Dermatology
Director, Center of Excellence in Eczema

Director, Laboratory of inflammatory Skin Diseases

Ieahn School of Medicine at Mount Sinai

New York, New York

Go online to access full CME/AAPA information,

, including faculty disclosures.

Zachary Jackson

Patient Actor

Franklin Newton

Patient Actor

Gina Ostmann
Patient Actor

Jaymirra Taylor

Copyri

Patient Actor

ht © 2000-2024, Peerview

34. STRIDE Il: Treat-to-Target Management Approach in IBD‘

inlcal response Clinical remission Normalization of Endoscopic healing
nue ROZ (rectal = ‘pie
atleast 50% in 1g = 0 and

PRO? (rectal co

bleeding and stoo! Io score In children

frequency), and in 1), and in children Normalized QOL
chidren decrease PUCAI <10 pot

in PUCAI of at

Feast 20 points CRP <ULN

Normal growth Et points

Therapy
ding
to risk

Active

18D

argets notre

Short es
1. Tumer D et al. Gastroenterology, 2021:160:1570-1583, PeerView.com

PeerView.com/VEX827 Copyright © 2000-2024, Peerview

35. Treat-to-Target in Rheumatoid Arthritis’

‘Adapt therapy according
to disease activity"

‘Adapt therapy
if state is lost®
(Consider comorbdties
‘and other patient factors)

‘Adapt therapy according
to disease activity"

(Consider comorbidities
_and other patient factors)

1. Smolen JS et al Ann Rheum Die. 2016753-15.

2 Shared decision with patient

PeerView.com/VEX827

‘Adapt therapy
if state is lost

(Consider comorbidities
‚and other patient factors)

PeerView.com

Copyright © 2000-2024, PeerView

36. A Different Way to Treat Immune-Mediated Inflammatory
Diseases: Target Signature Cytokine’

Organ-Based Concept

Reframing Immune-Mediated Inflammatory
Diseases through Signature Cytokine Hubs

TNFa

1.Schett G et al N Engl J Med. 2021:385.628-630. PeerView.com
PeerView.com/VEX827 Copyright © 2000-2024, Peerview

37. FDA-Approved Targeted Systemic
Therapy Classes for IMIDs'

1. hips accessdata Ida govseripts/ederldatindex.ctm. PeerView.com

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38. Faculty/Planner Disclosures

All relevant conflicts of interest have been mitigated prior to the commencement of
the activity.

Co-Chair/Planner

Saakshi Khattri, MBBS, MD, FAAD, FACR

Associate Professor

Board Certified in Internal Medicine, Rheumatology, Dermatology
Icahn School of Medicine at Mount Sinai

New York, New York

Saakshi Khattri, MBBS, MD, FAAD, FACR, has a financial interest/relationship or affiliation in the form of:

Consultant and/or Advisor for AbbVie Inc.; Arcutis Biotherapeutics, Inc.; Janssen Pharmaceuticals, Inc.;
Lilly; Regeneron Pharmaceuticals Inc./Sanofi; and UCB, Inc.

Grant/Research Support from AbbVie Inc. and Pfizer.

Speaker for AbbVie Inc.; Arcutis Biotherapeutics, Inc.; Janssen Pharmaceuticals, Inc.; Lilly; Pfizer;
Regeneron Pharmaceuticals Inc./Sanofi; and UCB, Inc.

PeerView.com/VEX827

39. Faculty/Planner Disclosures

All relevant conflicts of interest have been mitigated prior to the commencement of
the activity.

Co-Chair/Planner

Marla Dubinsky, MD

Professor of Pediatrics and Medicine

Chief, Division of Pediatric Gastroenterology and Nutrition
Co-Director, Susan and Leonard Feinstein IBD Clinical Center
Mount Sinai Kravis Children’s Hospital

Icahn School of Medicine, Mount Sinai New York

New York, New York

Marla Dubinsky, MD, has a financial interest/relationship or affiliation in the form of:

Consultant and/or Advisor for AbbVie Inc.; Abivax; AstraZeneca; Bristol Myers Squibb; Janssen
Pharmaceuticals, Inc.; Lilly; Merck & Co., Inc.; Pfizer; Prometheus Biosciences, Inc.; Prometheus
Laboratories; and Takeda Pharmaceutical Company Limited.

Other Financial or Material Support in the form of licensing fees for Takeda Pharmaceutical
Company Limited.

PeerView.com/VEX827

40. Faculty/Planner Disclosures

All relevant conflicts of interest have been mitigated prior to the commencement of

the activity.

Co-Chair/Planner
Emma Guttman-Yassky, MD, PhD

Waldman Professor and System Chair

The Kimberly and Eric J. Waldman Department of Dermatology
Director, Center of Excellence in Eczema

Director, Laboratory of Inflammatory Skin Diseases

Icahn School of Medicine at Mount Sinai

New York, New York

Emma Guttman-Yassky, MD, PhD, has a financial
interest/relationship or affiliation in the form of:

Consultant and/or Advisor for AbbVie Inc; Almirall, S.A.; Amgen
Inc.; AnaptysBio, Inc.; Apogee Therapeutics, Inc.; Apollo
Therapeutics; Artax Biopharma; AstraZeneca; Boehringer
Ingelheim International GmbH; Bristol Myers Squibb; Cara
Therapeutics; Centrexion Therapeutics; Connect Biopharm
Enveda Biosciences; Escient Pharmaceuticals; Fairmount Funds
Management LLC; Forest Laboratories Inc.; Galderma
GateBioscience; Google Ventures (GV); GSK; Horizon

PeerView.com/VEX827

Therapeutics USA, Inc.; Incyte; Inmagene; Janssen
Pharmaceuticals, Inc.; Japan Tobacco Inc.; Jasper Therapeutics,
Inc.; JT Central Pharmaceutical Research Institute; Kyowa Kirin
Inc.; Leo Pharma A/S; Lilly; Merck & Co., Inc.; Nektar; Novartis
Pharmaceuticals Corporation; NUMAB Therapeutics AG:
OrbiMed; Otsuka America Pharmaceutical, Inc.; Pfizer; Pharmaxis
Lid.; Pioneering Medicine VII, Inc.; Proteologix US, Inc.; RAPT
Therapeutics, Inc.; Regeneron Pharmaceuticals Inc.; Ribon
Therapeutics; Sanofi; SATO PHARMACEUTICAL

CO.,LTD.; Schrödinger, Inc.; SPARC; Teva Pharmaceutical
Industries Ltd.; and UCB, Inc.

Grant/Research Support from Amgen Inc.; AnaptysBio, Inc.; Aslan
Pharmaceuticals; Boehringer Ingelheim International GmbH:
Bristol Myers Squibb; Cara Therapeutics; Concert
Pharmaceuticals Inc.; GSK; Incyte; Janssen Pharmaceuticals,

Inc.; Kyowa Kirin, Inc.; Leo Pharma A/S; Pfizer; RAPT
Therapeutics, Inc.; Regeneron Pharmaceuticals Inc.; Sanofi; and
UCB, Inc. All research is paid to institution.

41. Faculty/Planner Disclosures

All relevant conflicts of interest have been mitigated prior to the commencement of
the activity.

Co-Chair/Planner

Alexis Ogdie, MD, MSCE

Associate Professor of Medicine and Epidemiology
Perelman School of Medicine

University of Pennsylvania

Philadelphia, Pennsylvania

Alexis Ogdie, MD, MSCE, has a financial interest/relationship or affiliation in the form of:

Consultant and/or Advisor for AbbVie Inc.; Amgen Inc.; Bristol Myers Squibb; Celgene Corporation;
CorEvitas, LLC; Gilead Sciences, Inc.; Janssen Pharmaceuticals, Inc.; Kopa/Twill Inc.; Lilly; Novartis
Pharmaceuticals Corporation; Pfizer; Takeda Pharmaceutical Company Limited; and UCB, Inc.
Grant/Research Support from AbbVie Inc.; Amgen Inc.; Forward Databank; National Institutes of Health
(NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Psoriasis
Foundation; Novartis Pharmaceuticals Corporation; Pfizer; and Rheumatology Research Foundation

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42. Planning Committee and Reviewer Disclosures

Planners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education,
the Crohn's and Colitis Foundation, the National Eczema Association, and the Spondylitis
Association of America do not have any relevant financial relationships related to this CE
activity unless listed below.

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