Safety of rituximab in the routine treatment of rheumatoid arthritis in italy in patients refractory to anti-tnfa drugs: Results from the observational retrospective-prospective rubino study

L. Bazzichi, D. Biasi, E. Tinazzi, M. Muratore, R. Pellerito, R. Russo, M. Corsaro Santi, P. De Sandre, O. Epis, M. Granata, B. Kroegler, C. Meschini, F. Versace, C. Astolfi, Bombardieri Stefano, Lunardi Claudio, Adami Silvano, Mathieu Alessandro, Pistone Giovanni, Sinigaglia LuigiConcesi Claudia, Del Sante Giovanni, Di Giuseppe Paolo, Fusaro Enrico, Laganà Bruno, Malavolta Nazzarena, Marasini Bianca, Mazzone Antonino, Romeo Nicoletta, Leardini Gianni, Martin Martin Luis Severino, Migliore Alberto

Research output: Contribution to journalArticle

Abstract

The paper reports the results from the observational retrospective-prospective RUBINO study conducted in Italy to assess the safety of rituximab in the treatment of rheumatoid arthritis (RA) in routine clinical practice. The percentage of patients who manifested at least one grade 3 or 4 adverse event (AE) assessed by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v.3) during the observation period (primary objective) was evaluated. The percentage of patients manifesting a severe AE (SAE), clinical response to rituximab treatment, clinical remission according to disease activity score for 28 joints (DAS28) criteria, markers of disease and quality of life were also assessed.

Fifty-three Italian rheumatology centers took part in the study. Patients with a diagnosis of RA and inadequate response to anti-tumor necrosis factor b (anti-TNFa) drugs were enrolled. Participating patients had previously received at least one cycle of rituximab, and treatment was still ongoing at the time of recruitment.

Out of 205 patients enrolled, 60% manifested no form of AE, 14.2% had at least one grade 3 or 4 AE, and 11.2% patients reported an SAE.

The overall percentage of patients manifesting AEs (40%) was lower compared to the DANCER (81% and 85%), REFLEX (85%) and RESET (85% and 69%) studies, but higher than that observed in the CERERRA registry (from 10.2% to 13.9%). This difference may be due to the shorter observation period applied in the CERERRA registry (only 12 months) compared to the RUBINO study (up to 3 years). All parameters of RA activity (erythrocyte sedimentation rate, C-reactive protein, health assessment questionnaire score, DAS28) improved significantly during the study.

Original languageEnglish
Pages (from-to)224-232
Number of pages9
JournalReumatismo
Volume66
Issue number3
DOIs
Publication statusPublished - 2014

Keywords

  • Rheumatoid arthritis Anti-TNF failures
  • Rituximab
  • Safety

ASJC Scopus subject areas

  • Rheumatology

Fingerprint Dive into the research topics of 'Safety of rituximab in the routine treatment of rheumatoid arthritis in italy in patients refractory to anti-tnfa drugs: Results from the observational retrospective-prospective rubino study'. Together they form a unique fingerprint.

  • Cite this

    Bazzichi, L., Biasi, D., Tinazzi, E., Muratore, M., Pellerito, R., Russo, R., Corsaro Santi, M., De Sandre, P., Epis, O., Granata, M., Kroegler, B., Meschini, C., Versace, F., Astolfi, C., Stefano, B., Claudio, L., Silvano, A., Alessandro, M., Giovanni, P., ... Alberto, M. (2014). Safety of rituximab in the routine treatment of rheumatoid arthritis in italy in patients refractory to anti-tnfa drugs: Results from the observational retrospective-prospective rubino study. Reumatismo, 66(3), 224-232. https://doi.org/10.4081/reumatismo.2014.748