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Safety and efficacy of ocrelizumab in rheumatoid arthritis patients with an inadequate response to methotrexate or tumor necrosis factor inhibitors: a systematic review and meta-analysis

  • Safety and Pharmacovigillance
  • Published:
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Abstract

We conducted this systematic reviews and meta-analysis to investigate the safety and efficacy of ocrelizumab in patients with active rheumatoid arthritis (RA) who exhibited resistance or intolerance to methotrexate or biological therapy. We performed a web-based literature search of PubMed, Google Scholar, EBSCO, Scopus, Embase, and Web of science for studies that compared ocrelizumab plus methotrexate versus methotrexate plus placebo in RA patients. Data were extracted from eligible studies and pooled as risk ratios (RR), using RevMan software. Pooling data from four RCTs (2230 patients) showed that ocrelizumab plus methotrexate were superior to methotrexate plus placebo at 24 weeks in terms of improvement on the American college of rheumatology (ACR20, ACR50, and ACR70) criteria (p < 0.00001), disease activity score 28-ESR (RR = 3.77, 95% CI [2.47, 5.74], p < 0.00001), and Sharp/van der Heijde radiological score (RR = 1.63, 95% CI [1.43, 1.85], p < 0.00001). These effects were consistent among all ocrelizumab doses. The rates of serious adverse events were comparable between the ocrelizumab and placebo containing groups (RR = 1, 95% CI [0.78, 1.28], p = 0.98). However, infusion related reactions were significantly higher in ocrelizumab group (RR = 2.13, 95% CI [1.69, 2.68], p < 0.00001), compared to placebo group. The combination of ocrelizumab plus methotrexate was superior to methotrexate plus placebo on all clinical and radiographic improvement scales. The incidence of adverse events, including serious adverse events, was comparable between both groups. Future trials should investigate the efficacy of ocrelizumab alone and develop strategies to alleviate its related infusion reactions.

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Abbreviations

ACR:

American college of rheumatology

DAS:

Disease activity score

DMARDs:

Disease modifying anti-rheumatic drugs

EULAR:

European League of Associations for Rheumatology

HAQ-DI:

Health Assessment Questionnaire-Disability Index

MTX:

Methotrexate

OCR:

Ocrelizumab

RA:

Rheumatoid Arthritis

RTX:

Rituximab

SHS:

Sharp/van der Heijde Score

TNF:

Tumor necrosis factor

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Authors and Affiliations

  1. Faculty of Medicine, Ain Shams University, Ramsis St, Abbasia, Cairo, 11591, Egypt

    Abdelrahman Ibrahim Abushouk

  2. NovaMed Medical Research Association, Cairo, Egypt

    Abdelrahman Ibrahim Abushouk, Ammar Ismail & Ahmed Elmaraezy

  3. Medical Research Group of Egypt, Cairo, Egypt

    Abdelrahman Ibrahim Abushouk, Hussien Ahmed, Ammar Ismail, Ahmed Elmaraezy, Ahmed Said Badr, Mohamed Gadelkarim & Mohammed Elnenny

  4. Faculty of Medicine, Zagazig University, El Sharkia, Egypt

    Hussien Ahmed

  5. Faculty of Medicine, Al-Azhar University, Cairo, Egypt

    Ammar Ismail, Ahmed Elmaraezy & Mohammed Elnenny

  6. Faculty of Medicine, Menoufia University, Menoufia, Egypt

    Ahmed Said Badr

  7. Student Research Unit, Menoufia University, Menoufia, Egypt

    Ahmed Said Badr

  8. Faculty of Medicine, Alexandria University, Alexandria, Egypt

    Mohamed Gadelkarim

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  1. Abdelrahman Ibrahim Abushouk
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Correspondence to Abdelrahman Ibrahim Abushouk.

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Abushouk, A.I., Ahmed, H., Ismail, A. et al. Safety and efficacy of ocrelizumab in rheumatoid arthritis patients with an inadequate response to methotrexate or tumor necrosis factor inhibitors: a systematic review and meta-analysis. Rheumatol Int 37, 1053–1064 (2017). https://doi.org/10.1007/s00296-017-3675-8

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