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 Table of Contents  
Year : 2019  |  Volume : 14  |  Issue : 1  |  Page : 77-78

No impact of seronegativity on the efficacy of a biosimilar rituximab in biologic-naïve patients with active rheumatoid arthritis

1 Department of Rheumatology, National Hospital, Kozhikode, Kerala, India
2 Department of Rheumatology, National Hospital; Centre for Rheumatology, Kozhikode, Kerala, India

Date of Web Publication14-Mar-2019

Correspondence Address:
Dr. Vinod Ravindran
Centre for Rheumatology, Kozhikode - 673 009, Kerala
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/injr.injr_158_18

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How to cite this article:
Jamshid NP, Ravindran V. No impact of seronegativity on the efficacy of a biosimilar rituximab in biologic-naïve patients with active rheumatoid arthritis. Indian J Rheumatol 2019;14:77-8

How to cite this URL:
Jamshid NP, Ravindran V. No impact of seronegativity on the efficacy of a biosimilar rituximab in biologic-naïve patients with active rheumatoid arthritis. Indian J Rheumatol [serial online] 2019 [cited 2021 Jan 18];14:77-8. Available from:

Dear Editor,

Rituximab (RTX) is widely used in the treatment of rheumatoid arthritis (RA). It is an anti-CD20 monoclonal antibody and has proven efficacy and safety in the treatment of RA, including the biologic-naïve patients.[1],[2] Previously, we had shown that a more affordable biosimilar version of RTX was efficacious in seropositive RA.[3] However, the strategy to use RTX only in seropositive patients excludes several who would potentially benefit from its long-term efficacy. In this prospective study, we appraised the usefulness of a biosimilar RTX (Mabtas™ RA) in seronegative RA.

All willing consecutive adult patients with RA who continued to have active disease (disease activity score,[4] DAS28-erythrocyte sedimentation rate [ESR] ≥5.1) despite standard combination disease-modifying antirheumatic drug therapy for more than 3 months (including oral or subcutaneous methotrexate at 15–25 mg/week and low dose, i.e., <7.5 mg/day prednisolone equivalent glucocorticoids) and were infused two doses of 1000 mg of biosimilar RTX (Mabtas™ RA) 2 weeks apart were prospectively screened. Only those patients who were seronegative for both rheumatoid factor and anti-citrullinated peptide antibodies were included in the analysis. All patients were assessed in the standard care, which comprised follow-up once every 3 months and assessments of disease activity (by DAS28) and disability (by Health Assessment Questionnaire [HAQ]-Indian version)[5] and recording of any adverse events at any time. At each visit, the number of patients who were either in remission (i.e., DAS28-ESR of <2.6) or low disease activity (LDA; DAS28-ESR ≤3.2 to >2.6) was recorded.

Seventeen patients (mean age, 55 ± 4.4 years; 12 females, disease duration range 12–68 months) were included. They had a follow-up range of 9–14 months. Two patients had interstitial lung disease (ILD). At 24 weeks, compared to the baseline, both DAS28-ESR (5.44 ± 0.18 vs.2.58 ± 0.76, P < 0.0001) and HAQ (1.83 ± 0.56 vs. 1.12 ± 0.29, P < 0.0001) showed significant improvement. Sustained remission (mean range, 8 months) was noted in 15 and 2 achieved LDA. This response was sustained, and none of them required retreatment with RTX in the follow-up period. De-escalation of existing therapy including glucocorticoids was possible in 14 patients. No worsening of ILD was documented in those two patients. Infusion reactions were none, and no serious adverse events were observed.

Notwithstanding the obvious limitations of this study, including lack of a control arm and small numbers of patients, it is noteworthy that seronegativity did not have any impact on the efficacy of biosimilar RTX (Mabtas™ RA) in our cohort of biologic-naïve patients with active RA. Further, we have had the same results using a lower dose of the same biosimilar RTX using two doses of 500 mg, given 2 weeks apart (unpublished data). In conclusion, the results of our study underscores the importance of considering all patients with RA for RTX therapy irrespective of their serological status. Such a strategy may lessen the tremendous burden of RA on patients with this disease and the society.

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Conflicts of interest

There are no conflicts of interest.

  References Top

Rubbert-Roth A, Tak PP, Zerbini C, Tremblay JL, Carreño L, Armstrong G, et al. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: Results of a phase III randomized study (MIRROR). Rheumatology (Oxford) 2010;49:1683-93.  Back to cited text no. 1
Emery P, Deodhar A, Rigby WF, Isaacs JD, Combe B, Racewicz AJ, et al. Efficacy and safety of different doses and retreatment of rituximab: A randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study evaluating rituximab's efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis 2010;69:1629-35.  Back to cited text no. 2
Roshique KK, Ravindran V. Efficacy and safety of a biosimilar rituximab in biologic naïve patients with active rheumatoid arthritis. Clin Rheumatol 2015;34:1289-92.  Back to cited text no. 3
Prevoo ML, Van't Hof MA, Kuper HH, van Leeuwen MA, Van de Putte LB, Van Riel PL, et al. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44-8.  Back to cited text no. 4
Kumar A, Malaviya AN, Pandhi A, Singh R. Validation of an Indian version of the health assessment questionnaire in patients with rheumatoid arthritis. Rheumatology (Oxford) 2002;41:1457-9.  Back to cited text no. 5


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