PMID- 20483046
OWN - NLM
STAT- MEDLINE
DCOM- 20100823
LR  - 20170112
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
VI  - 28
IP  - 2
DP  - 2010 Mar-Apr
TI  - Sustained efficacy and safety, including patient-reported outcomes, with 
      etanercept treatment over 5 years in patients with ankylosing spondylitis.
PG  - 238-45
AB  - OBJECTIVES: To assess long-term safety and clinical efficacy of etanercept 25 mg 
      subcutaneously twice weekly up to 5 years in subjects with ankylosing spondylitis 
      (AS). METHODS: An open-label (OL), multicentre, phase 4, 156-week extension study 
      of subjects with AS who had completed a 12-week randomised, placebo-controlled 
      study (N=84; n=45 etanercept, n=39 placebo) followed by a 96-week OL study (n=81; 
      n=42 etanercept/etanercept; n=39 placebo/etanercept); 59 subjects who completed 
      the 96-week OL extension enrolled in the current OL trial and continued 
      etanercept 25 mg BIW for an additional 156 weeks (total duration: 264 weeks, 
      original etanercept group; 252 weeks, original placebo group). Safety was based 
      on spontaneous reports of adverse events (AEs). Last observation carried forward 
      was used for imputation of missing values. RESULTS: Thirty-seven of 59 subjects 
      (63%) completed 5 years of etanercept treatment. Serious non infectious AEs and 
      serious infections occurred at a rate of 0.17 and 0.03 events per subject years, 
      respectively; inflammatory bowel disease and uveitis (including iritis and 
      iridiocyclitis) occurred at 0.01 and 0.14, respectively. No cases of tuberculosis 
      or opportunistic infections were reported. Assessment in Ankylosing Spondylitis 
      (ASAS) responses and improvements in Bath Ankylosing Spondylitis Functional Index 
      and spinal mobility were sustained from week 108 through week 264. CONCLUSIONS: 
      Etanercept was well tolerated with no new safety signals detected in subjects 
      with AS over 5 years. Clinical efficacy and improvements in function and mobility 
      seen during the double-blind and first OL study were sustained. These results 
      support etanercept therapy for the long-term management of this chronic disease.
FAU - Martin-Mola, E
AU  - Martin-Mola E
AD  - Hospital, La Paz, Madrid, Spain. emartinmola.hulp@salud.madrid.org
FAU - Sieper, J
AU  - Sieper J
FAU - Leirisalo-Repo, M
AU  - Leirisalo-Repo M
FAU - Dijkmans, B A C
AU  - Dijkmans BA
FAU - Vlahos, B
AU  - Vlahos B
FAU - Pedersen, R
AU  - Pedersen R
FAU - Koenig, A S
AU  - Koenig AS
FAU - Freundlich, B
AU  - Freundlich B
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100513
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Receptors, Tumor Necrosis Factor)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Activities of Daily Living
MH  - Adult
MH  - Antirheumatic Agents/*administration & dosage/adverse effects
MH  - Etanercept
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/*administration & dosage/adverse effects
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Motor Activity
MH  - *Patient Satisfaction
MH  - Receptors, Tumor Necrosis Factor/*administration & dosage
MH  - Spondylitis, Ankylosing/*drug therapy
MH  - Treatment Outcome
EDAT- 2010/05/21 06:00
MHDA- 2010/08/24 06:00
CRDT- 2010/05/21 06:00
PHST- 2009/10/28 00:00 [received]
PHST- 2010/02/16 00:00 [accepted]
PHST- 2010/05/21 06:00 [entrez]
PHST- 2010/05/21 06:00 [pubmed]
PHST- 2010/08/24 06:00 [medline]
AID - 718 [pii]
PST - ppublish
SO  - Clin Exp Rheumatol. 2010 Mar-Apr;28(2):238-45. Epub 2010 May 13.