Program Faculty Scientific Committee Majed Khraishi, MD St. John's, NF Janet Pope, MD London, ON...

Program Faculty

Scientific Committee• Majed Khraishi, MD

St. John's, NF

• Janet Pope, MDLondon, ON

• Anthony Russell, MDEdmonton, AB

Participants• Carole Bertrand, MD

Terrebonne, QC

• Louis Bessette, MDQuebec, QC

• George Ecker, MDFredericton, NB

• Shahin Jamal, MDVancouver, BC

• Ariel Masetto, MDSherbrooke, QC

• Robert Charles Offer, MDPenticton, BC

Rheumatoid Arthritis

Highlights of EULAR 2013

Compiled by:Louis Bessette, MDGeorge Ecker, MDShahin Jamal, MD

Majed Khraishi, MD Robert Charles Offer, MD

Anthony Russell, MD

Burmester G, et al. Presented at EULAR 2013; Abstract #OP0067.

Effect of Methotrexate Dosing on Adalimumab Efficacy, Pharmacokinetics,

and Safety: CONCERTO StudyClinical Question: What is the effect of methotrexate (MTX) dose in combination with adalimumab in patients with early rheumatoid arthritis (RA)?

Methods: 26-week, double-blind, trial in MTX and biologic-naïve patients with active RA of < 1 year duration in the Study to Determine the Effects of Different Doses of MTX When Taken With Adalimumab in Subjects With Early RA (CONCERTO)

– Patients were randomized 1:1:1:1 to weekly oral MTX (2.5, 5, 10, or 20 mg) and received open-label adalimumab 40 mg every other week (EOW)


Proportion of Patients Achieving Low Disease Activity or Remission (DAS28[CRP]) Over Six Months: CONCERTO Study

0

40

30

70

Pa

tient

s ac

hiev

ing

DA

S2

8 <

2.6

(%

)

60

50

LDAS (primary endpoint)*

43

6057

44

20

10

DAS28 remission**

28

45

3732

Adalimumab + MTX 2.5 mg (n = 98)

Adalimumab + MTX 20 mg (n = 98)



*Low disease activity (LDAS): Disease Activity Score (DAS28) C-Reactive Protein (CRP) < 3.2;**Remission: DAS28(CRP) < 2.6. p values for trends: p = 0.005 for LDAS, p = 0.008 for remission.


Which Dose of MTX? CONCERTO: Safety Summary

Additional safety results:• Only the proportion of patients experiencing infectious AEs increased with increasing

MTX dose; serious infectious events did not increase • All other AEs occurred in < 2% of all randomized patients • No obvious trends existed pertaining to liver function tests • Infections and abnormal hair loss increased with increasing MTX dose

Treatment-Emergent Events

Adalimumab + 2.5 mg MTX(n = 98)

Adalimumab + 5 mg MTX(n = 100)



Total(n = 395)

Any adverse event (AE) 61 (62.2) 59 (59.0) 66 (66.7) 68 (69.4) 254 (64.3)

AE leading to discontinuation 3 (3.1) 0 2 (2.0) 4 (4.1) 9 (2.3)

Serious AE 5 (5.1) 2 (2.0) 3 (3.0) 7 (7.1) 17 (4.3)

Severe AE 3 (3.1) 2 (2.0) 5 (5.1) 6 (6.1) 16 (4.1)

Infectious AE 20 (20.4) 17 (17.0) 24 (24.2) 34 (34.7) 95 (24.1)

Serious infections 0 2 (2.0) 0 0 2 (0.5)

Anemia 2 (2.0) 0 1 (1.0) 2 (2.0) 5 (1.3)

Leukopenia 1 (1.0) 1 (1.0) 0 0 2 (0.5)

Injection site reaction 1 (1.0) 5 (5.0) 5 (5.1) 3 (3.1) 14 (3.5)


Effect of Methotrexate Dosing on Adalimumab Efficacy, Pharmacokinetics,

and Safety: CONCERTO StudyTake-home Messages:• In combination with adalimumab, higher dosages

of MTX (> 10 mg) are better• If there are side effects on 20 mg and/or the

patient is in remission/LDAS, it may be appropriate to reduce the MTX dose to 10 mg


Gaujoux-Viala C, et al. Presented at EULAR 2013; Abstract #THU0221.

Optimization of MTX: Data from the French ESPOIR Cohort

Clinical Question: What is the symptomatic and structural impact of MTX optimization in early arthritis (EA) in daily clinical practice over two years?

Methods:• Patients were considered “optimized” if started

> 10 mg MTX per week and > 20 mg by six months

Gaujoux-Viala C, et al. Presented at EULAR 2013; Abstract #THU0221.

Program Faculty Scientific Committee Majed Khraishi, MD St. John's, NF Janet Pope, MD London, ON...

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