Article Text

PDF
FRI0171 Achieving long-term comprehensive disease control with adalimumab and methotrexate in patients with early rheumatoid arthritis in the optima study
  1. P. Emery1,
  2. J.S. Smolen2,
  3. R. Fleischmann3,
  4. R. van Vollenhoven4,
  5. S. Florentinus5,
  6. S. Santra5,
  7. H. Kupper6,
  8. L. Redden5,
  9. A. Kavanaugh7
  1. 1Univ of Leeds, Leeds, United Kingdom
  2. 2Medical Univ of Vienna & Hietzing Hospital, Vienna, Austria
  3. 3U of Texas Southwestern Med Center, Dallas, United States
  4. 4Karolinska Univ Hospital, Stockholm, Sweden
  5. 5Abbott, Abbott Park, United States
  6. 6Abbott GmbH, Ludwigshafen, Germany
  7. 7UCSD, La Jolla, United States

Abstract

Background The goals of the treat-to-target strategy for rheumatoid arthritis (RA) are to reduce inflammation, prevent structural damage, and to normalize function.

Objectives To compare the percentage of RA patients (pts) achieving comprehensive disease control (CDC) after obtaining stable DAS28<3.2 at wks 22 and 26 (target) with adalimumab (ADA)+methotrexate (MTX) or placebo (PBO)+MTX (responders, R) to the percentage of pts achieving CDC with open-label (OL) ADA+MTX in PBO+MTX pts not achieving target (inadequate responders, IR). CDC was defined as low disease activity (DAS28<3.2)+no radiographic progression (ΔmTSS≤0.5)+normal function (HAQ<0.5).

Methods MTX-naïve pts ≥18 yr with RA <1 yr, active disease [DAS28(CRP)>3.2, ESR≥28 mm/hr or CRP≥1.5 mg/dL], and either >1 erosion, RF+, or anti-CCP+ were randomized to ADA+MTX or PBO+MTX for 26 wks (Period 1, P1). ADA+MTX-R pts were randomized to withdraw ADA or continue ADA+MTX for an additional 52 wks (P2). PBO+MTX-R pts continued on MTX and pts with IR received OL ADA+MTX in P2. This post-hoc analysis examines the proportion of pts achieving CDC at wks 26, 52, and 78. For MTX IR pts the proportion of pts achieving CDC at wk 52 was compared with CDC response for ADA+MTX at wk 26 in P1. Baseline characteristics were compared for pts achieving CDC vs. non-achievers at wk 78.

Results At wk 26, 30% and 16% of pts achieved CDC with ADA+MTX and PBO+MTX, respectively (P <.001, table). At wk 78, high DAS28<3.2 response rates were seen in ADA+MTX(R)→ADA+MTX and PBO+MTX(R)→PBO+MTX pts (91%/81%); ΔmTSS≤0.5 response was 89%/78%; HAQ<0.5 was the most difficult to achieve, in 67%/64%. CDC at wk 78 was similar for ADA+MTX(R)→ADA+MTX and PBO+MTX(R)→PBO+MTX pts (P=.10). Using wk 26 as baseline for ΔmTSS, 24% (80/332) of PBO+MTX(IR)$→ $ADA+MTX pts achieved CDC after 26 wks of OL ADA+MTX, similar to pts on ADA+MTX in P1.

Table 1. Number (%) pts achieving CDCa

Although some baseline patient/disease characteristics differed between CDC achievers and non-achievers at wk 78, they were not consistent across treatment groups.

Conclusions Comprehensive disease control is an achievable goal for many early RA pts who respond initially to MTX or ADA+MTX. Introducing ADA in MTX-IR pts resulted in a similar proportion of pts achieving CDC as observed in all pts with initial ADA+MTX therapy.

Disclosure of Interest P. Emery Consultant for: Abbott, Pfizer, Merck, Roche, BMS, UCB, J. Smolen Grant/Research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB, Consultant for: Abbott, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB, R. Fleischmann Grant/Research support from: Abbott, Consultant for: Abbott, R. van Vollenhoven Grant/Research support from: Abbott, GSK, Merck, Pfizer, Roche, UCB, Consultant for: Abbott, GSK, Merck, Pfizer, Roche, UCB, S. Florentinus Shareholder of: Abbott, Employee of: Abbott, S. Santra Shareholder of: Abbott, Employee of: Abbott, H. Kupper Shareholder of: Abbott, Employee of: Abbott, L. Redden Shareholder of: Abbott, Employee of: Abbott, A. Kavanaugh Grant/Research support from: Abbott, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB, Consultant for: Abbott, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.