Efficacy of Iguratimod-based therapy for the treatment of SAPHO syndrome: a prospective cohort study.

OBJECTIVE

Due to the rarity and unknown pathogenesis of SAPHO syndrome, there is no consensus on its treatment. This study aimed to evaluate the effectiveness of Iguratimod-based therapy-monotherapy or combined with alendronate-for treating SAPHO syndrome patients.

METHODS

We conducted a prospective cohort study at Beijing Jishuitan Hospital from August 2022 to August 2024. Consecutively recruited patients diagnosed with SAPHO syndrome received Iguratimod monotherapy (Group A), combination therapy with Iguratimod and alendronate (Group B), or NSAIDs alone (Group C). Patients were followed for 6 months. Outcome measures included changes in Health Assessment Questionnaire (HAQ), Visual Analogue Scale (VAS), and Physician's Global Assessment of Disease Activity (PGDA) scores.

RESULTS

Seventy-two patients (52 females, 20 males) were enrolled. Forty-seven patients completed follow-up: 19 received Iguratimod monotherapy (Group A), 26 received combination therapy (Group B), and 2 received NSAIDs monotherapy (Group C). At 6 months, both Group A and Group B showed significant reductions in HAQ, VAS, and PGDA scores compared to baseline [Group A-HAQ: 0.01 ± 0.05 vs. 0.26 ± 0.39, 95%CI(0.06, 0.43), p = 0.014; VAS: 1.42 ± 1.92 vs. 6.68 ± 1.86, 95%CI(4.16, 6.36), p < 0.001; PGDA: 1.26 ± vs. 5.74 ± 2.10, 95%CI(3.30, 5.64), p < 0.001; n = 19; Group B-HAQ: 0.01 ± 0.06 vs. 0.35 ± 0.38, 95%CI(0.18, 0.49), p < 0.001; VAS: 1.54 ± 1.65 vs. 7.04 ± 2.52, 95%CI(4.36, 6.64), p < 0.001; PGDA: 1.27 ± 1.25 vs. 5.92 ± 2.65, 95%CI(3.49, 5.82), p < 0.001; n = 26]. Significant improvements were also observed at the first month. In Group C, 66.7% (4/6) of patients required additional medications within the first month.

CONCLUSION

Iguratimod-based therapy may be a potential treatment for SAPHO syndrome patients, providing rapid and sustained symptom relief over 6 months. Key Points • This is the first prospective cohort study to evaluate the efficacy of iguratimod based treatment for SAPHO syndrome. • Iguratimod may lead to rapid symptom relief for SAPHO syndrome. • The combination of iguratimod and alendronate may achieve persistent symptom improvement for SAPHO syndrome.