Drug outcome survey to evaluate anti-TNF treatment in rheumatoid arthritis: an Italian observational study (the DOSE study)

Clin Exp Rheumatol. Nov-Dec 2015;33(6):779-87. Epub 2015 Nov 17.


Objectives: The aim of this paper is to analyse the use of anti-TNF drugs in current Italian practice, evaluate clinical responses to treatment, and identify possible predictors of negative response in patients with rheumatoid arthritis (RA).

Methods: DOSE is a non-interventional, prospective study of patients with active RA treated for the first time with anti-TNF agents in 21 Italian hospitals. Demographic and clinical characteristics of patients, treatments and outcome measures were assessed. Outcome measures used were EULAR response, DAS28 remission and HAQ remission at 12 months. A stepwise logistic regression model was used to study the predictors of non-response.

Results: Of 299 RA patients (mean 53.8 ± 12.8 years, 76.1% female), DAS28 was >5.1 in 60.5% of patients and HAQ was >1 in 65.9%. Etanercept was the most prescribed anti-TNF. DMARDs were used in 77.6% of patients (methotrexate in 59.2%). Significant improvements in clinical and laboratory parameters were observed at 12 months. The proportion of patients classed as non-responders remained high, and varied according to assessment criteria. The main predictors independently and significantly associated with a high risk of non-response were: age and female gender for all outcome criteria; high DAS28 value for disease remission; and HAQ >1 for disability remission.

Conclusions: In Italian anti-TNF treatment for RA, age, gender, and high values of both disease activity and disability were predictors of non-response to first-line therapy with anti-TNF drugs. Future studies should consider optimal second-line therapies for RA patients who do not achieve remission to their first anti-TNF treatment.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab* / administration & dosage
  • Adalimumab* / adverse effects
  • Adult
  • Age Factors
  • Aged
  • Antirheumatic Agents* / administration & dosage
  • Antirheumatic Agents* / adverse effects
  • Arthritis, Rheumatoid* / diagnosis
  • Arthritis, Rheumatoid* / drug therapy
  • Arthritis, Rheumatoid* / epidemiology
  • Disability Evaluation
  • Drug Monitoring
  • Drug Resistance
  • Drug Therapy, Combination
  • Etanercept* / administration & dosage
  • Etanercept* / adverse effects
  • Female
  • Humans
  • Infliximab* / administration & dosage
  • Infliximab* / adverse effects
  • Italy / epidemiology
  • Male
  • Middle Aged
  • Prospective Studies
  • Severity of Illness Index
  • Sex Factors
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*


  • Antirheumatic Agents
  • Tumor Necrosis Factor-alpha
  • Infliximab
  • Adalimumab
  • Etanercept