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. 2023 Jun 1;25(1):91.
doi: 10.1186/s13075-023-03076-w.

Real-life drug retention rate and safety of rituximab when treating rheumatic diseases: a single-centre Swiss retrospective cohort study

Alexandre Dumusc  1   2 , Fahad Alromaih  3 , Matthieu Perreau  4   5 , Thomas Hügle  3   4 , Pascal Zufferey  3   4 , Diana Dan  3   4
Affiliations

Real-life drug retention rate and safety of rituximab when treating rheumatic diseases: a single-centre Swiss retrospective cohort study

Alexandre Dumusc et al. Arthritis Res Ther. .

Abstract

Background: In Switzerland, rituximab (RTX) is licenced for the treatment of rheumatoid arthritis (RA) and ANCA-associated vasculitis (AAV) but is frequently used off-label to treat other auto-immune diseases (AID), especially connective tissue diseases (CTD). We aimed to characterise the use of RTX in AID in a real-life Swiss setting and compare RTX retention rates and safety outcomes between patients treated for RA, CTD and AAV.

Methods: A retrospective cohort study of patients who started RTX in the Rheumatology Department for RA or AID. The RTX retention rate was analysed using Kaplan-Meier survival curves. Occurrences of serious adverse events (SAE), low IgG levels and anti-drug antibodies (ADA) were reported.

Results: Two hundred three patients were treated with RTX: 51.7% had RA, 29.6% CTD, 9.9% vasculitis and 8.9% other AIDs. The total observation time was 665 patient-years. RTX retention probability at 2 years (95%CI) was similar for RA and CTD 0.65 (0.55 to 0.73), 0.60 (0.47 to 0.72) and lower for vasculitis 0.25 (0.09 to 0.45). Survival curves for RTX retention matched closely (p = 0.97) between RA and CTD patients but were lower for patients with vasculitis due to a higher percentage of induced remission. Patients with vasculitis (95%) and CTD (75%) had a higher rate of concomitant glucocorticoid use than RA (60%). Moderate to severe hypogammaglobulinaemia was observed more frequently in patients with vasculitis (35%) than with RA (13%) or CTD (9%) and was associated with an increased risk of presenting a first infectious SAE (HR 2.01, 95% CI 1.04 to 3.91). The incidence rate of SAE was 23.3 SAE/100 patient-years (36% were infectious). When searched, ADAs were observed in 18% of the patients and were detected in 63% of infusions-related SAE. 10 patients died during RTX treatment and up to 12 months after the last RTX infusion, 50% from infection.

Conclusion: RTX retention rates are similar for patients with RA and CTD but lower for those with vasculitis due to more frequent remission. Patients treated with RTX for vasculitis present more SAE and infectious SAE than patients with RA and CTD, potentially due to a higher use of concomitant glucocorticoids and the occurrence of hypogammaglobulinaemia.

Keywords: Auto-immune diseases; Connective tissue disease; Drug retention rate; Off-label; Rheumatoid arthritis; Rituximab; Vasculitis.

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Conflict of interest statement

The authors declare no competing interests concerning this study.

Figures

Fig. 1
Fig. 1
Rituximab retention rate. Kaplan–Meier curve showing the retention probability of rituximab treatment by indication with 95% CI
See this image and copyright information in PMC

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References

    1. Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793–806. doi: 10.1002/art.22025. - DOI - PubMed
    1. Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaître O, Cohen P, et al. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014;371(19):1771–1780. doi: 10.1056/NEJMoa1404231. - DOI - PubMed
    1. Terrier B, Pagnoux C, Perrodeau É, Karras A, Khouatra C, Aumaître O, et al. Long-term efficacy of remission-maintenance regimens for ANCA-associated vasculitides. Ann Rheum Dis. 2018;77(8):1150–1156. doi: 10.1136/annrheumdis-2017-212768. - DOI - PubMed
    1. Charles P, Perrodeau É, Samson M, Bonnotte B, Néel A, Agard C, et al. Long-Term Rituximab Use to Maintain Remission of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Trial. Ann Intern Med. 2020;173(3):179–187. doi: 10.7326/M19-3827. - DOI - PubMed
    1. Smith RM, Jones RB, Specks U, Bond S, Nodale M, Aljayyousi R, et al. Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis. Ann Rheum Dis. 2020;79(9):1243–1249. doi: 10.1136/annrheumdis-2019-216863. - DOI - PMC - PubMed

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