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Safety and efficacy of tocilizumab as monotherapy or in combination with methotrexate in Tunisian patients with active rheumatoid arthritis and inadequate response to disease-modifying anti-rheumatic drugs in conditions close to clinical practice

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Abstract

Objectives

We aimed to assess the safety and efficacy of tocilizumab as monotherapy or in combination with methotrexate in a routine clinical practice setting in Tunisian patients with RA who did not respond to conventional treatment with disease-modifying anti-rheumatic drugs (DMARDs-IR).

Method

A total of 51 DMARDs-IR adult patients with moderate to severe RA participated in a phase IIIb, open-label clinical trial. Patients received 8 mg/kg of tocilizumab every 4 weeks in combination with a DMARD or as monotherapy during 24 weeks. The study was extended to 24 other weeks for those who had at least a moderate response at the end of the initial phase. Safety and efficacy of tocilizumab were analysed.

Results

Four patients discontinued treatment prematurely due to an adverse event. The most common AEs were hypercholesterolemia (18 cases), increased triglycerides (17 cases), increased transaminases (15 cases), rash (14 cases), neutropenia (7 cases), digestive disorders (3 cases) and respiratory disorders (3 cases). After 52 weeks, 90.5% of patients responded to treatment. At the end of the study, 61.9% of the patients had a mild RA and almost 50% of patients were in remission. Overall, 29.2, 6.3 and 4.3% of patients achieved ACR20, ACR50 and ACR70 responses, respectively. Additionally, the study showed a significant improvement in all individual parameters of ACR core data.

Conclusions

Treatment with tocilizumab was well tolerated and showed a fast and sustained efficacy in Tunisian patients with moderate to severe active RA who had an inadequate response to DMARDs.

Key Points

• Up to 40% of RA patients remain inadequate responders to a prior csDMARD or a tumour necrosis factor α inhibitor (TNFi) biological agent. A non-TNF biological agent like tocilizumab with or without methotrexate is recommended in those patients.

• In this study, tocilizumab treatment improved the number of responders, the number of patients in remission, and the evolution of disease activity. The meaningful clinical improvement seen denotes a rapid and sustained response to treatment.

• Tocilizumab presented a favourable safety profile with few withdrawals due to AEs, consistently with what was observed in other trials.

• This study provides new information about the safety and efficacy of tocilizumab in a patient population resembling that expected in clinical practice among the Tunisian population.

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Acknowledgements

The authors would like to thank Dr Emna El Hammi for providing medical writing assistance on behalf of INTO EVIDENCE, a medical communications company.

Funding

This study was funded by ROCHE Tunisia SA.

Author information

Authors and Affiliations

  1. Rheumatology Department, Farhat Hached Hospital, Sousse, Tunisia

    Elyes Bouajina

  2. Rheumatology Department, Mongi Slim Hospital, La Marsa, Tunisia

    Leith Zakraoui

  3. Rheumatology Department, Mohammed Kassab Institute, Tunis, Tunisia

    Montassar Kchir

  4. Internal Medicine Department, Habib Thameur Hospital, Tunis, Tunisia

    Samir Kochbati

  5. Rheumatology Department, Hedi Chaker Hospital, Sfax, Tunisia

    Sofiene Baklouti

Authors
  1. Elyes Bouajina
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  2. Leith Zakraoui
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  3. Montassar Kchir
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  4. Samir Kochbati
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  5. Sofiene Baklouti
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Corresponding author

Correspondence to Elyes Bouajina.

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Disclosures

None.

Ethical approval

The study was conducted according to the Declaration of Helsinki and the International Committee on Harmonisation Good Clinical Practice guidelines, together with the applicable laws in Tunisia. The protocol was reviewed and approved by regulatory authorities as well as the appropriate independent ethics committees of each participating centre.

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All patients provided written informed consent.

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Bouajina, E., Zakraoui, L., Kchir, M. et al. Safety and efficacy of tocilizumab as monotherapy or in combination with methotrexate in Tunisian patients with active rheumatoid arthritis and inadequate response to disease-modifying anti-rheumatic drugs in conditions close to clinical practice. Clin Rheumatol 39, 1449–1455 (2020). https://doi.org/10.1007/s10067-019-04815-8

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  • DOI: https://doi.org/10.1007/s10067-019-04815-8

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