title: Adverse events of anti-tumor necrosis factor α therapy in ankylosing spondylitis.
abstract: OBJECTIVE
  This study aims to investigate the prevalence of short-term and long-term adverse events associated with tumor necrosis factor-α (TNF-α) blocker treatment in Chinese Han patients suffering from ankylosing spondylitis (AS).
  
  
  METHODS
  The study included 402 Chinese Han AS patients treated with TNF-α blockers. Baseline data was collected. All patients were monitored for adverse events 2 hours following administration. Long-term treatment was evaluated at 8, 12, 52 and 104 weeks follow-up for 172 patients treated with TNF-α blockers.
  
  
  RESULTS
  Short-term adverse events occurred in 20.15% (81/402), including rash (3.5%; 14/402), pruritus (1.2%; 5/402), nausea (2.2%; 9/402), headache (0.7%; 3/402), skin allergies (4.0%; 16/402), fever (0.5%; 2/402), palpitations (3.0%; 12/402), dyspnea (0.5%; 2/402), chest pain (0.2%; 1/402), [corrected] abdominal pain (1.0%; 4/402), hypertension (2.2%; 9/402), papilledema (0.5%; 2/402), laryngeal edema (0.2%; 1/402) and premature ventricular contraction (0.2%; 1/402). Long-term adverse events occurred in 59 (34.3%; 59/172) patients, including pneumonia (7.6%; 13/172), urinary tract infections (9.9%; 17/172), otitis media (4.7%; 8/172), tuberculosis are (3.5%; 6/172) [corrected], abscess (1.2%; 2/172), oral candidiasis (0.6%; 1/172), elevation of transaminase (1.7%; 3/172), anemia (1.2%; 2/172), hematuresis (0.6%; 1/172), constipation (2.3%; 4/172), weight loss (0.6%; 1/172), exfoliative dermatitis (0.6%; 1/172). CRP, ESR and disease duration were found to be associated with an increased risk of immediate and long-term adverse events (P<0.05). Long-term treatment with Infliximab was associated with more adverse events than rhTNFR-Fc (P<0.01).
  
  
  CONCLUSIONS
  This study reports on the prevalence of adverse events in short-term and long-term treatment with TNF-α blocker monotherapy in Chinese Han AS patients. Duration of disease, erythrocyte sedimentation rate, and c-reactive protein serum levels were found to be associated with increased adverse events with anti-TNF-α therapy. Long-term treatment with Infliximab was associated with more adverse events than rhTNFR-Fc.
authors.affiliation: Department of Rheumatology and Immunology, Changhai Hospital Second Military Medical University, Yangpu District, No.168 Changhai Road, Shanghai-200433, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Tong
authors.affiliation: Department of Rheumatology and Immunology, Changhai Hospital Second Military Medical University, Yangpu District, No.168 Changhai Road, Shanghai-200433, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Cai
authors.affiliation: Department of Neurosurgery, Mayo Clinic, Rochester Minnesota, 55902, United States of America.
authors.forename: Tristan
authors.initials: T
authors.lastname: de Mooij
authors.affiliation: Department of Rheumatology and Immunology, Changhai Hospital Second Military Medical University, Yangpu District, No.168 Changhai Road, Shanghai-200433, China.
authors.forename: Xia
authors.initials: X
authors.lastname: Xu
authors.affiliation: Department of Rheumatology and Immunology, Changhai Hospital Second Military Medical University, Yangpu District, No.168 Changhai Road, Shanghai-200433, China.
authors.forename: Shengming
authors.initials: S
authors.lastname: Dai
authors.affiliation: Dep. of Physical Medicine & Rehabilitation, Mayo Clinic, Rochester, Minnesota, 55902, United States of America; Department of Anesthesiology Pain Division, Mayo Clinic, Rochester, Minnesota, United States of America.
authors.forename: Wenchun
authors.initials: W
authors.lastname: Qu
authors.affiliation: Department of Rheumatology and Immunology, Changhai Hospital Second Military Medical University, Yangpu District, No.168 Changhai Road, Shanghai-200433, China.
authors.forename: Dongbao
authors.initials: D
authors.lastname: Zhao
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002681:China; D000068800:Etanercept / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013167:Spondylitis, Ankylosing / Q000188:drug therapy / Q000503:physiopathology*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068800:Etanercept