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OP0181 Treating to Target of Minimal Disease Activity and Normal Function in Polyarticular Juvenile Idiopathic Arthritis with Adalimumab: Analysis from A Phase 3 Clinical Trial
  1. N. Ruperto1,
  2. D. Lovell2,
  3. P. Quartier3,
  4. A. Ravelli4,
  5. M. Karunaratne5,
  6. J. Kalabic6,
  7. A. Cardoso7,
  8. A. Martini1,
  9. G. Horneff8
  1. 1Printo-IRCCS, Genova, Italy
  2. 2PRCSG, Cincinnati Children's Hospital Medical Center, Cincinnati, United States
  3. 3Hôpital Necker-Enfants Malades, Paris, France
  4. 4Istituto G. Gaslini and Università degli Studi di Genovav, Genova, Italy
  5. 5AbbVie, North Chicago, United States
  6. 6AbbVie Deutschland GmbH and Co. KG, Ludwigshafen, Germany
  7. 7AbbVie, Amadora, Portugal
  8. 8Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany

Abstract

Background The Juvenile Arthritis Disease Activity Score (JADAS)1 is becoming widely accepted in juvenile idiopathic arthritis (JIA) for defining a treat to target strategy.

Objectives To evaluate the percentage of patients (pts) treated with adalimumab (ADA) (±methotrexate [MTX]) that achieved minimal disease activity (MDA) and both MDA and normalization of function.

Methods This post hoc analysis assessed pts aged 4-17 with polyarticular JIA that were enrolled in a phase 3 clinical trial (DE038)2, which consisted of a 16 week (wk) open-label (OL) lead-in with ADA ± MTX, 32wk double-blind (DB) phase with ADA or placebo (PBO)±MTX, and OL extension (OLE) with ADA ± MTX up to 346wks. Clinical and functional outcomes were assessed by 27-joint JADAS (JADAS27), based on C-reactive protein, and Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI). MDA was defined as JADAS27<3.8 and normal function was defined as CHAQ-DI<0.5. Pts who entered the DB phase were included, and data was stratified by MTX treatment (tx) at time of study entry.

Results At baseline, 75 pts, who had prior MTX, had a mean JADAS27 of 21.2 and CHAQ-DI of 0.9, and 58 pts, who were MTX naïve or had withdrawn from MTX prior to study, had a mean JADAS27 of 23.8 and CHAQ-DI of 1.2. After 16wks of OL ADA, the mean JADAS27 was 6.1 and 6.7 and CHAQ-DI was 0.4 and 0.5 for ADA+MTX and ADA-MTX, respectively, indicating a clinically meaningful change. Clinical improvements were seen at wk48 and wk88, and the mean JADAS27 at wk88 was 2.6, 3.0, 4.3, and 5.0 for ADA+MTX, ADA-MTX, PBO+MTX, and PBO-MTX, respectively, with the greatest improvements seen in ADA continuation. No pts had MDA or normal function at baseline; however, a good proportion achieved MDA and normal function during OL ADA (Table). Fewer pts achieved MDA and normal function in the PBO tx compared with ADA continuation at both wk48 and wk88.

Table 1.

Number and percentage of patients achieving minimal disease activity and minimal disease activity with normal function

Conclusions ADA, regardless of MTX, resulted in a high percentage of pts achieving and sustaining MDA and normal function. Some improvement was seen in pts treated with PBO during the DB period; however, continued tx with ADA shows better overall clinical and functional outcomes. A target of comprehensive disease control with MDA and normal function is achievable and aligned with current goals of JIA tx.

References

  1. Consolaro A et al. Arthritis Rheum 2012.

  2. Lovell DJ et al. NEJM 2008.

Acknowledgements AbbVie sponsored the study (NCT00048542), contributed to design, participated in collection, analysis, interpretation of data, writing, reviewing, and approval of final version. Medical writing was provided by Jessica L. Suboticki, PhD, of AbbVie.

Disclosure of Interest N. Ruperto Employee of: GASLINI Hospital, which has received contributions to support the research activities of the network of PRINTO from AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharmaceuticals, Speakers bureau: Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, Janssen Biologics B.V., MedImmune, Roche, and Wyeth/Pfizer, D. Lovell Grant/research support: National Institutes of Health – NIAMS, Consultant for: Astra-Zeneca, Centocor, Amgen, Bristol Meyers Squibb, Abbott, Pfizer, Regeneron, Roche, Novartis, UBC, Forest Research Institute, Horizon, and Johnson & Johnson, Speakers bureau: Novartis and Roche, P. Quartier Grant/research support: AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum, Consultant for: AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum, A. Ravelli Grant/research support: Pfizer, Consultant for: Hoffman La-Roche, Speakers bureau: Hoffman La-Roche, Centocor, Bristol-Myers Squibb, Pfizer, Novartis and AbbVie Inc, M. Karunaratne Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie, A. Cardoso Shareholder of: AbbVie, Employee of: AbbVie, A. Martini Employee of: GASLINI Hospital, which has received contributions to support the research activities of the network of PRINTO from AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”, GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharmaceuticals, Speakers bureau: Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, and MedImmune, G. Horneff Grant/research support: AbbVie, Pfizer, and Roche, Speakers bureau: AbbVie, Novartis, Pfizer, and Roche

DOI 10.1136/annrheumdis-2014-eular.1600

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