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A hierarchical cluster analysis for clinical profiling of tofacitinib treatment response in patients with rheumatoid arthritis

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Abstract

Tofacitinib is the first oral JAK inhibitor approved for treating rheumatoid arthritis (RA). To enhance our understanding of tofacitinib drug response, we used hierarchical clustering to analyse the profiles of patient who responded to the treatment in a real-world setting. Patients who commenced on tofacitinib treatment were selected from 12 major rheumatology centres in Malaysia. The aim was to assess their response to tofacitinib defined as achieving DAS28-CRP/ESR ≤ 3.2 and DAS28 improvement > 1.2 at 12 weeks. A hierarchical clustering analysis was performed using sociodemographic and clinical parameters at baseline. All 163 RA patients were divided into three clusters (Clusters 1, 2 and 3) based on specific clinical factors at baseline including bone erosion, antibody positivity, disease activity and anaemia status. Cluster 1 consisted of RA patients without bone erosion, antibody negative, low baseline disease activity measure and absence of anaemia. Cluster 2 comprised of patients without bone erosion, RF positivity, anti-CCP negativity, moderate to high baseline disease activity score and absence of anaemia. Cluster 3 patients had bone erosion, antibody positivity, high baseline disease activity and anaemia. The response rates to tofacitinib varied among the clusters: Cluster 1 had a 79% response rate, Cluster 2 had a 66% response rate, and Cluster 3 had a 36% response rate. The differences in response rates between the three clusters were found to be statistically significant. This cluster analysis study indicates that patients who are seronegative and have low disease activity, absence of bone erosion and no signs of anaemia may have a higher likelihood of benefiting from tofacitinib therapy. By identifying clinical profiles that respond to tofacitinib treatment, we can improve treatment stratification yielding significant benefits and better health outcomes for individuals with RA.

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Fig. 1
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Data availability

Data is available from the corresponding author on resonable request.

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Acknowledgements

We would like to thank the Director General of Health Malaysia for the approval to publish this work [NMRR-21-1423-60760 (IIR)].

Funding

This research received funding from the IMU University Research Grant [PHMS I/2021 (04)] as part of PhD project.

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Authors and Affiliations

  1. School of Postgraduate Studies, IMU University, Kuala Lumpur, Malaysia

    Sivakami Janahiraman

  2. Department of Pharmacy, Hospital Selayang, Ministry of Health Malaysia, Selangor Darul Ehsan, Malaysia

    Sivakami Janahiraman

  3. Rheumatology Unit, Department of Medicine, Hospital Putrajaya, Ministry of Health Malaysia, Putrajaya, Malaysia

    Nor Shuhaila Shahril

  4. Sector for Biostatistics & Data Repository, National Institutes of Health Complex, Ministry of Health Malaysia, Selangor Darul Ehsan, Malaysia

    Vivek Jason Jayaraj

  5. Rheumatology Unit, Department of Medicine, Hospital Selayang, Ministry of Health Malaysia, Selangor Darul Ehsan, Malaysia

    Suyin Ch’ng

  6. Rheumatology Unit, Department of Medicine, Hospital Tuanku Ja’afar Seremban, Ministry of Health Malaysia, Negeri Sembilan, Malaysia

    Liu Hong Eow

  7. Rheumatology Unit, Department of Medicine, Hospital Tengku Ampuan Rahimah, Ministry of Health Malaysia, Selangor Darul Ehsan, Malaysia

    Eashwary Mageswaren

  8. Rheumatology Unit, Department of Medicine, Hospital Pulau Pinang, Ministry of Health Malaysia, Pulau Pinang, Malaysia

    Ai Lee Lim

  9. Rheumatology Unit, Department of Medicine, Hospital Melaka, Ministry of Health Malaysia, Melaka, Malaysia

    Hwee Cheng Chong

  10. Rheumatology Unit, Department of Medicine, Hospital Raja Permaisuri Bainun, Ministry of Health Malaysia, Perak Darul Ridzuan, Malaysia

    ** Seung Ong

  11. Rheumatology Unit, Department of Medicine, Hospital Raja Perempuan Zainab II, Ministry of Health Malaysia, Kelantan Darul Naim, Malaysia

    Asmahan Mohamed Ismail

  12. Rheumatology Unit, Department of Medicine, Hospital Sultanah Nur Zahirah, Ministry of Health Malaysia, Terengganu Darul Iman, Malaysia

    Siti Mariam Ab Rahim

  13. Rheumatology Unit, Department of Medicine, Hospital Sultan Ismail, Ministry of Health Malaysia, Johor Darul Ta’zim, Malaysia

    Chun Ruh Ng

  14. Rheumatology Unit, Department of Medicine, Hospital Tengku Ampuan Afzan, Ministry of Health Malaysia, Pahang Darul Makmur, Malaysia

    Dayang Masyrinartie Suahilai

  15. Rheumatology Unit, Department of Medicine, Hospital Sultanah Bahiyah, Ministry of Health Malaysia, Kedah Darul Aman, Malaysia

    Azwarina Hanim Ramlan

  16. Immunogenetic Unit, Institute for Medical Research, National Institutes of Health Complex, Ministry of Health Malaysia, Selangor Darul Ehsan, Malaysia

    Chun Lai Too

  17. Centre for Cancer and Stem Cell Research Development and Innovation (IRDI), Institute for Research, IMU University, Kuala Lumpur, Malaysia

    Chee Onn Leong

  18. AGTC Genomics, Kuala Lumpur, Malaysia

    Chee Onn Leong

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  1. Sivakami Janahiraman
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  2. Nor Shuhaila Shahril
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Contributions

SJ conceived the research idea and developed the study methodology. SJ, NSS, TCL, and CLO made substantial contributions to the workflow design. SJ, NSS, TCL, SC, LHE, EM, ALL, HCC, PSO, AMI, SMR, CRN, DMS, and AHR carried out the study implementation and acquisition of the data. SJ and VJJ performed the statistical analysis and interpretation. SJ involved in manuscript drafting, writing and editing. NSS and TCL participated in revising the draft critically for important intellectual content. All authors contributed to the final approval of the version published.

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Correspondence to Sivakami Janahiraman.

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Key Points

• Tofacitinib is effective in alleviating RA symptoms and disease progression, but there are significant differences in how individuals respond to the drug.

• Stratifying risk based on clinical factors can help identify patients who are most likely to benefit from treatment.

• Rheumatologists can utilise risk stratification in develo** effective treatment plans for RA patients who do not respond to tofacitinib.

• Seronegative patients with low disease activity, absence of bone erosion and no evidence of anaemia may respond better to tofacitinib therapy.

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Janahiraman, S., Shahril, N.S., Jayaraj, V.J. et al. A hierarchical cluster analysis for clinical profiling of tofacitinib treatment response in patients with rheumatoid arthritis. Clin Rheumatol (2024). https://doi.org/10.1007/s10067-024-07035-x

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