PMID- 22895833 OWN - NLM STAT- MEDLINE DCOM- 20131219 LR - 20161020 IS - 1439-7609 (Electronic) IS - 1439-7595 (Linking) VI - 23 IP - 3 DP - 2013 May TI - Twenty-four-week clinical results of adalimumab therapy in Japanese patients with rheumatoid arthritis: retrospective analysis for the best use of adalimumab in daily practice. PG - 466-77 LID - 10.1007/s10165-012-0705-y [doi] AB - OBJECTIVE: We evaluated patient drug adherence to and efficacy and safety of adalimumab (ADA) based on data collected from approximately 200 patients to retrospectively examine the best use of ADA in Japanese patients with longstanding rheumatoid arthritis (RA) managed in daily practice. METHODS: For explorative comparisons, patients were stratified by prior use or no use of biologics (Bio-naive vs. Bio-switch) and concomitant use (+) or no use (-) of methotrexate (MTX) into four subgroups. The primary efficacy endpoint was extent of improvement in the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) from baseline to 24 weeks assessed as European League Against Rheumatism (EULAR) good response. Secondary endpoints included ADA treatment continuation as represented by Kaplan-Meier survival curves and percentages of patients achieving remission as defined by DAS28-ESR <2.6. RESULTS: Overall, mean DAS28-ESR significantly decreased from 5.6 +/- 1.2 at baseline to 4.1 +/- 1.7 at week 24 (p < 0.0001), and >30 % of patients achieved EULAR good response. Subgroup analyses indicated that patients in the Bio-naive and MTX (+) subgroup showed the highest EULAR good response rate of 37.3 % at week 24. The three most commonly reported adverse events (AEs) were skin allergies such as injection-site reactions, infections, and respiratory disorders such as interstitial lung lesions and organizing pneumonia. CONCLUSION: In conclusion, ADA therapy resulted in significant clinical response in established Japanese patients with RA treated in daily practice. It also demonstrated generally good safety and tolerability. It was suggested that the best use of ADA may be in biologically naive patients with concomitant administration of MTX. FAU - Kaneko, Atsushi AU - Kaneko A AD - Department of Orthopaedic Surgery and Rheumatology, National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan. a-kaneko@xj.commufa.jp FAU - Hirano, Yuji AU - Hirano Y FAU - Fujibayashi, Takayoshi AU - Fujibayashi T FAU - Hattori, Yosuke AU - Hattori Y FAU - Terabe, Kenya AU - Terabe K FAU - Kojima, Toshihisa AU - Kojima T FAU - Ishiguro, Naoki AU - Ishiguro N LA - eng PT - Journal Article DEP - 20120816 PL - England TA - Mod Rheumatol JT - Modern rheumatology JID - 100959226 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - FYS6T7F842 (Adalimumab) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM MH - Adalimumab MH - Adult MH - Aged MH - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use MH - Antirheumatic Agents/adverse effects/*therapeutic use MH - Arthritis, Rheumatoid/*drug therapy MH - Drug Therapy, Combination MH - Female MH - Humans MH - Japan MH - Longitudinal Studies MH - Male MH - Medication Adherence MH - Methotrexate/adverse effects/therapeutic use MH - Middle Aged MH - Retrospective Studies MH - Severity of Illness Index MH - Treatment Outcome EDAT- 2012/08/17 06:00 MHDA- 2013/12/20 06:00 CRDT- 2012/08/17 06:00 PHST- 2012/03/01 00:00 [received] PHST- 2012/06/04 00:00 [accepted] PHST- 2012/08/17 06:00 [entrez] PHST- 2012/08/17 06:00 [pubmed] PHST- 2013/12/20 06:00 [medline] AID - 10.1007/s10165-012-0705-y [doi] PST - ppublish SO - Mod Rheumatol. 2013 May;23(3):466-77. doi: 10.1007/s10165-012-0705-y. Epub 2012 Aug 16.