Program Faculty Scientific Committee Majed Khraishi, MD St. John's, NF Janet Pope, MD London, ON Anthony Russell, MD Edmonton, AB Participants Carole.

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Program Faculty Scientific Committee Majed Khraishi, MD St. John's, NF Janet Pope, MD London, ON Anthony Russell, MD Edmonton, AB Participants Carole Bertrand, MD Terrebonne, QC Louis Bessette, MD Quebec, QC George Ecker, MD Fredericton, NB Shahin Jamal, MD Vancouver, BC Ariel Masetto, MD Sherbrooke, QC Robert Charles Offer, MD Penticton, BC

Rheumatoid Arthritis Highlights of EULAR 2013 Compiled by: Louis Bessette, MD George Ecker, MD Shahin 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 Study Clinical 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) Burmester G, et al. Presented at EULAR 2013; Abstract #OP0067.

Proportion of Patients Achieving Low Disease Activity or Remission (DAS28[CRP]) Over Six Months: CONCERTO Study Patients achieving DAS28 < 2.6 (%) LDAS (primary endpoint)* DAS28 remission** Adalimumab + MTX 2.5 mg (n = 98) Adalimumab + MTX 20 mg (n = 98) Adalimumab + MTX 10 mg (n = 99) Adalimumab + MTX 5 mg (n = 100) *Low disease activity (LDAS): Disease Activity Score (DAS28) C-Reactive Protein (CRP) < 3.2; **Remission: DAS28(CRP) < 2.6. p values for trends: p = for LDAS, p = for remission. Burmester G, et al. Presented at EULAR 2013; Abstract #OP0067.

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 mg MTX (n = 98) Adalimumab + 5 mg MTX (n = 100) Adalimumab + 10 mg MTX (n = 99) Adalimumab + 20 mg MTX (n = 98) 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)02 (2.0)4 (4.1)9 (2.3) Serious AE5 (5.1)2 (2.0)3 (3.0)7 (7.1)17 (4.3) Severe AE3 (3.1)2 (2.0)5 (5.1)6 (6.1)16 (4.1) Infectious AE20 (20.4)17 (17.0)24 (24.2)34 (34.7)95 (24.1) Serious infections02 (2.0)002 (0.5) Anemia2 (2.0)01 (1.0)2 (2.0)5 (1.3) Leukopenia1 (1.0) 002 (0.5) Injection site reaction1 (1.0)5 (5.0)5 (5.1)3 (3.1)14 (3.5) Burmester G, et al. Presented at EULAR 2013; Abstract #OP0067.

Effect of Methotrexate Dosing on Adalimumab Efficacy, Pharmacokinetics, and Safety: CONCERTO Study Take-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 Burmester G, et al. Presented at EULAR 2013; Abstract #OP0067.

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.