PMID- 21327436 OWN - NLM STAT- MEDLINE DCOM- 20121207 LR - 20221207 IS - 1437-160X (Electronic) IS - 0172-8172 (Print) IS - 0172-8172 (Linking) VI - 32 IP - 6 DP - 2012 Jun TI - Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: a sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis. PG - 1511-9 LID - 10.1007/s00296-010-1784-8 [doi] AB - The aim is to investigate the relationship of duration of rheumatoid arthritis (RA) with safety and effectiveness of etanercept (ETN) in Japan. Post-marketing surveillance data for 7,099 patients treated with ETN were analyzed. Baseline characteristics, treatment effectiveness, incidence of adverse events (AEs), and serious AEs (SAEs) in relation to duration of RA were studied. At baseline, patients with RA for longer duration were older, weighed less, had more comorbidities, allergies, and corticosteroid use, but smoked less and had less morning stiffness. By 2-5 years with RA, more than half of the patients had advanced to Steinbrocker radiographic stage III or IV. Methotrexate (MTX) was the most commonly used pre-treatment disease-modifying antirheumatic drug; however, concomitant MTX use and its dose were lower among patients with longer duration of RA. Remission rates (26.6%) were greatest among patients having RA for <2 years. Less AEs and SAEs were observed among patients with shorter duration of RA. These results suggest that RA treatment in Japan in the era pre-biologics may not have been adequate to control disease activity and prevent joint destruction. Patients with shorter duration of RA may have better physical status which allows the opportunity to treat more intensively putting a higher percentage of patients in remission and possibly decreasing exposure to SAEs. FAU - Koike, Takao AU - Koike T AD - Hokkaido University Graduate School of Medicine, Sapporo, Japan. FAU - Harigai, Masayoshi AU - Harigai M FAU - Inokuma, Shigeko AU - Inokuma S FAU - Ishiguro, Naoki AU - Ishiguro N FAU - Ryu, Junnosuke AU - Ryu J FAU - Takeuchi, Tsutomu AU - Takeuchi T FAU - Tanaka, Yoshiya AU - Tanaka Y FAU - Yamanaka, Hisashi AU - Yamanaka H FAU - Fujii, Koichi AU - Fujii K FAU - Yoshinaga, Takunari AU - Yoshinaga T FAU - Freundlich, Bruce AU - Freundlich B FAU - Suzukawa, Michio AU - Suzukawa M LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20110216 PL - Germany TA - Rheumatol Int JT - Rheumatology international JID - 8206885 RN - 0 (Antirheumatic Agents) RN - 0 (Immunoglobulin G) RN - 0 (Receptors, Tumor Necrosis Factor) RN - OP401G7OJC (Etanercept) SB - IM MH - Antirheumatic Agents/adverse effects/*therapeutic use MH - Arthritis, Rheumatoid/diagnosis/*drug therapy/ethnology MH - Asian People MH - Chi-Square Distribution MH - Drug Substitution MH - Drug Therapy, Combination MH - Etanercept MH - Female MH - Humans MH - Immunoglobulin G/adverse effects/*therapeutic use MH - Japan/epidemiology MH - Logistic Models MH - Male MH - Middle Aged MH - Odds Ratio MH - Product Surveillance, Postmarketing MH - Proportional Hazards Models MH - Receptors, Tumor Necrosis Factor/*therapeutic use MH - Risk Assessment MH - Risk Factors MH - Severity of Illness Index MH - Time Factors MH - Treatment Outcome PMC - PMC3364409 EDAT- 2011/02/18 06:00 MHDA- 2012/12/12 06:00 PMCR- 2011/02/16 CRDT- 2011/02/18 06:00 PHST- 2010/09/20 00:00 [received] PHST- 2010/12/30 00:00 [accepted] PHST- 2011/02/18 06:00 [entrez] PHST- 2011/02/18 06:00 [pubmed] PHST- 2012/12/12 06:00 [medline] PHST- 2011/02/16 00:00 [pmc-release] AID - 1784 [pii] AID - 10.1007/s00296-010-1784-8 [doi] PST - ppublish SO - Rheumatol Int. 2012 Jun;32(6):1511-9. doi: 10.1007/s00296-010-1784-8. Epub 2011 Feb 16.