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Combination of methotrexate and sulfasalazine is an efficacious option for axial spondyloarthritis in a resource-limited, real-world clinical setting: a prospective cohort study

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Abstract

Objective

Evaluation of response to combination conventional synthetic DMARD (csDMARD) therapy with methotrexate (MTX) and sulfasalazine (SSZ) in active axial spondyloarthritis (axSpA) patients without peripheral arthritis (group 1) as compared to active axSpA with peripheral arthritis (group 2), who are economically constrained for biologicals.

Methods

A prospective, observational, single-centre, cohort study on 150 consecutive active axSpA patients who were already initiated on the above mentioned combination csDMARD therapy and satisfying the other pre-defined eligibility criteria, was conducted between July 2016 and July 2017 using ASAS20 response as primary outcome measure at 3 and 6 months post treatment.

Results

ASAS20 response at 3 months was achieved in 31/58 (53.4%) and in 24/36 (66.6%) in groups 1 and 2, respectively (p = 0.2); at 6 months, these figures were 45/76 (59.2%) and 28/44 (63.6%), respectively (p = 0.6). Similarly, there was significant reduction in mean ASAS NSAID index from 29.6 to 14 over 6 months from baseline (p = 0.001), and it was similar in both groups. Using BASDAI ≥ 4 to define active disease, a 34% reduction in requirement of biologicals was also observed.

Conclusion

In resource-limited population, treatment with combination of methotrexate and sulphasalazine over a period of 6 months is equally efficacious in patients with active axSpA with and without peripheral arthritis, as evidenced by improved ASAS20 response rates, reduction in NSAID use and fewer patients switching to biologicals.

Key Points

• Combination of MTX+SSZ was efficacious and safe in active axSpA patients who had economic hardships to use biologicals.

• This benefit in axSpA patients was similar between those without any peripheral arthritis and those with.

• MTX+SSZ combination therapy also demonstrated NSAID sparing action.

• Combination of MTX and SSZ prevented escalation to biological therapy as per a BASDAI score driven policy.

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Data availability

Study data (raw) will be made available on request.

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Acknowledgements

The authors would also like to thank the Institutional Review Board of Christian Medical College, Vellore, India.

Funding

The study was funded by the Intramural Fluid Research Grant of Christian Medical College, Vellore, India (IRB No 10207 dated 8/8/2016).

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Authors and Affiliations

  1. Department of Clinical Immunology and Rheumatology, Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu, 632004, India

    Arvind Ganapati & Debashish Danda

  2. Department of Biostatistics, Christian Medical College, Vellore, India

    Mahasampath Gowri & Belavendra Antonisamy

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  1. Arvind Ganapati
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  2. Mahasampath Gowri
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  3. Belavendra Antonisamy
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  4. Debashish Danda
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Correspondence to Debashish Danda.

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The study was approved by the Institutional Review Board and Ethics Committee, Christian Medical College, Vellore, India.

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All patients recruited for the study were provided with a written, informed consent for participation.

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Ganapati, A., Gowri, M., Antonisamy, B. et al. Combination of methotrexate and sulfasalazine is an efficacious option for axial spondyloarthritis in a resource-limited, real-world clinical setting: a prospective cohort study. Clin Rheumatol 40, 1871–1879 (2021). https://doi.org/10.1007/s10067-020-05433-5

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