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Clinical efficacy and safety of adalimumab versus etanercept in patients with ankylosing spondylitis and total spinal ankylosis in Croatia: a multicentre 12-month follow-up study

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Abstract

Objective

To evaluate the 12-month efficacy and safety profile of adalimumab and etanercept in patients with ankylosing spondylitis (AS) and total spinal ankylosis (TSA).

Type of study design

Case-series follow-up study.

Design

Twenty-eight patients (26 men and 2 women) with active AS (BASDAI > 4) and TSA were treated as follows: 19 patients receiving adalimumab and 9 patients receiving etanercept. Twelve-month data related to the efficacy and safety of these two TNF-alpha inhibitors were evaluated. The primary endpoint was ASAS 20 (the ASsessment in AS International Working Group criteria for 20% improvement) at weeks 12 and 52. Other measures that were evaluated were function (BASFI), disease activity (BASDAI), patient’s and physician’s global disease assessment on visual analogue scale (VAS) and C-reactive protein.

Results

In both adalimumab and etanercept groups, there was a significant improvement in all observed variables (baseline compared to weeks 12 and 52). This improvement was sustained for the whole follow-up period. In the adalimumab group, at week 12, ASAS 20 was achieved in 18/19 patients and at week 52 in 17/19 patients. In the etanercept group, at week 12 ASAS 20 was achieved in all patients and at week 52 in 6/9 patients.

Conclusion

In patients with active AS and TSA, adalimumab and etanercept treatment showed significant improvement in function and disease activity. No serious side effects or adverse effects were observed in our cohort.

Key Points

• TNF-alpha inhibitors can be effective treatment options for patients with AS and having total spinal ankylosis.

• Patients with advanced AS should not be disregarded as good candidates for treatment with biologic disease-modifying antirheumatic drugs.

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Authors and Affiliations

Authors

Contributions

All authors contributed to the study conception and design.

Material preparation was performed by FG and SG; data collection was performed by ĐBN, PP, JM-V, BA, TK, SN, MH, AGG, NLM and SG; and analysis was performed by FG.

The first draft was written by FG and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

This research has been performed in accordance with the ethical standard laid down in the 1964 Declaration of Helsinki and its later amendments.

The manuscript does not contain clinical studies or patient’s personal data.

Corresponding author

Correspondence to Frane Grubišić.

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Grubišić, F., Naglić, Đ.B., Perić, P. et al. Clinical efficacy and safety of adalimumab versus etanercept in patients with ankylosing spondylitis and total spinal ankylosis in Croatia: a multicentre 12-month follow-up study. Clin Rheumatol 41, 2417–2421 (2022). https://doi.org/10.1007/s10067-022-06177-0

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