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4CPS-151 Optimisation programme of biological therapies in rheumatoid arthritis: results of create registry after 3 years
  1. S de la Fuente Ruiz1,
  2. P Font Ugalde2,
  3. M Cárdenas Aranzana1,
  4. MC Castro Villegas2,
  5. M Romero Gómez2,
  6. R Ortega Castro2,
  7. J Calvo Guitiérrez2,
  8. D Ruiz Vílchez2,
  9. E Colllantes Estévez2
  1. 1Reina Sofia University Hospital, Pharmacy Unit, Cordoba, Spain
  2. 2Reina Sofia University Hospital, Rheumatology Unit, Cordoba, Spain


Background Dose optimisation (dose reduction or dose spacing) is a therapeutic strategy applied in patients with rheumatoid arthritis (RA) who have managed to maintain clinical remission. This strategy reduces the frequency of adverse effects and promotes cost savings.

Purpose Evaluate effectiveness of dose optimisation after 3 years.

Evaluate effectiveness of restoring standard dosing after optimised dose failure.

Explore if it is possible to identify any difference in effectiveness regarding type of biological therapy used (anti-TNF versus non-anti-TNF drugs).

Material and methods Patients with RA (Criteria American College of Rheumatology 1987) of the CREATE registry (patients treated in real-life conditions) who had clinical remission (Disease-Activity-Score 28 (DAS28) <2.6) of at least 6 months of duration in November 2013, constituted the cohort of patients who were optimised.

Optimisation protocol meant reduction of 20% to 50% of the dose.

A multidisciplinary team (rheumatologists and pharmacists) was involved in decision-making, which included the application of protocols and review of patients at least every 2 months.

Data regarding patients’ characteristics and disease activity were collected at evaluations and recorded on the CREATE registry database.

Results A cohort of 70 patients with RA received optimised doses and were prospectively followed-up for 3 years, with a mean age of 56.9 (13.7) years, 78.6% were females, 68.8% were positive rheumatoid factor and 66.7% ACPA +.

Twenty-six patients (37.3%, 95% CI: 26.72 to 49.28) with optimised dose maintained criteria for clinical remission throughout follow-up, with an average DAS28 of 1.99 (1.07).

The median survival time of the optimisation regimen was 15.24 (4.65) months (95% CI: 4.66 to 25.83).

All patients who relapsed were switched to a standard dose. In our cohort, all these patients managed to reach clinical remission (DAS28 <2.6, p<0.05).

No statistically significant differences were found when comparing patients regarding type of optimised drug (anti-TNF versus non-anti-TNF) (test log. rank: 0.239, P 0.625).

Conclusion Dose optimisation strategy of biological therapies in patients with established RA that achieved sustained remission were possible in 37.3% of cases in real clinical practice (CREATE Registry) and it was maintained for 3 years.

This strategy is possible when the disease is persistently controlled and it is independent of type of drug administered (anti-TNF versus non-anti-TNF).

When relapse occurs, switching to standard dose allows reaching the therapeutic goal again.

No conflict of interest

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