FRI0121 Characteristics of patients with early rheumatoid arthritis who have a delayed response to treatment with methotrexate in monotherapy or in combination with adalimumab

Background In patients (pts) with rheumatoid arthritis (RA), treat-to-target recommendations call for adjustment of treatment if a target is not met within 3–6 months of initiation. While some pts continue therapy beyond 3–6 months despite not achieving the target, it’s unclear if they still can achieve the target, and how the timing of target attainment impacts long-term outcomes. Objectives To evaluate clinical, functional, and radiographic outcomes on the basis of initial time to low disease activity (LDA) attainment among early RA pts who are naive to MTX, or are MTX-insufficient responders (MTX-IR). Methods This post hoc analysis included pts receiving MTX in monotherapy or in combination with adalimumab (ADA) in 2 randomised, controlled trials (RCTs) of MTX-naive pts with early RA: PREMIER included a 104 week (wk) RCT1; OPTIMA included a 26 wk RCT followed by treatment adjustments based on a target of LDA at wks 22 and 262. Pts not achieving stable LDA received open-label (OL) ADA +MTX for an additional 52 wks (MTX-inadequate responders, IR). Pts were subgrouped by treatment and time to first LDA event [SDAI ≤11: 0- 6-≤12 mths]. The following were summarised for each subgroup: mean values and change from baseline in SDAI, HAQ-DI and modified total Sharp score (mTSS). The proportions of pts achieving SDAI remission (REM) at 1 year (yr) were assessed. Results Roughly equal proportions of pts on MTX alone experienced their first LDA response between 0- 6-≤12 mths (17%). More pts on ADA+MTX experienced LDA within 3 mths (0- 6-≤12 mths groups (14% and 4% for MTX-naive and MTX-IR backgrounds). Approximately 50% of the 0– Among MTX-naive pts, pts on ADA+MTX had greater ΔHAQ and smaller ΔmTSS than pts on MTX alone at Wks 26 and 52 (table 1). Regardless of their time to first SDAI LDA response, pts on MTX monotherapy or ADA+MTX experienced comparable improvements in SDAI, HAQ-DI and comparable ΔmTSS at Wks 26 and 52. Table 1 Mean Values at Baseline and Change From Baseline in Clinical, Functional, and Structural Parameters in Patients with Early RA Receiving MTX or ADA+MTX, on the Basis of First Achievement of Low Disease Activity by SDAI. Conclusions Pts on ADA+MTX achieved a first SDAI LDA response earlier than pts on MTX monotherapy, regardless of whether they were MTX-naive or MTX-IR. More pts with a very early response went on to achieve SDAI REM at 1 year. However, pts with a longer time (>6 mths) to their first SDAI LDA response had comparable clinical, functional and radiographic outcomes compared to pts who responded earlier (within 3 or 6 mths). Therefore, achieving a clinical response in the direction of the treatment target, even if not yet achieving it, may be sufficient to continue therapy in appropriate pts. References [1] Breedveld, et al. Arthritis & Rheum2006;54:26. [2] Smolen, et al. Lancet2014;383:321. Acknowledgements AbbVie: study sponsor, contributed to design, data collection, analysis, interpretation; and writing, reviewing, approval of final version. Medical writing: Naina Barretto of AbbVie. Disclosure of Interest J. Smolen Grant/research support from: AbbVie, Consultant for: AbbVie, X. Bu Shareholder of: AbbVie, Employee of: AbbVie, X. Wang Shareholder of: AbbVie, Employee of: AbbVie, J. Suboticki Shareholder of: AbbVie, Employee of: AbbVie, A. Kavanaugh Grant/research support from: AbbVie Inc., Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB., Consultant for: expert advice to AbbVie Inc., Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB