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 AOU Pisana Ospedale Santa Chiara, Pisa, Italy.
  • D. Biasi AOU Integrata, Verona, Italy.
  • E. Tinazzi AOU Integrata, Verona, Italy.
  • M. Muratore Ospedale Galateo, Lecce, Italy.
  • R. Pellerito A.S.O. Ordine Mauriziano di Torino, Torino, Italy.
  • R. Russo AORN A. Cardarelli, Napoli, Italy.
  • M. Corsaro Santi Ospedale San Giovanni Bosco, Napoli, Italy.
  • P. De Sandre Ospedale San Bortolo, Vicenza, Italy.
  • O. Epis Ospedale Niguarda Ca’ Granda, Milano, Italy.
  • M. Granata AO San Filippo Neri, Roma, Italy.
  • B. Kroegler Policlinico Tor Vergata, Roma, Italy.
  • C. Meschini Ospedale Belcolle, Viterbo, Italy.
  • F. Versace Ospedale San Paolo, Savona, Italy.
  • C. Astolfi | cinzia.astolfi@roche.com Roche Italia S.p.A, Monza, Italy.

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.

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Published
2014-11-06
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Articles
Keywords:
Rituximab, Rheumatoid arthritis Anti-TNF failures, Safety.
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How to Cite
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. (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