Short-Term Effectiveness of Sulfasalazine and Tofacitinib in NSAID-Refractory Reactive Arthritis: An Observational Study.

BACKGROUND

Reactive arthritis (ReA) is a lower-limb predominant oligoarthritis that follows genitourinary or gastrointestinal infection with a 2-4 week latency. Up to 40% can progress to chronicity. There is no approved disease-modifying anti-rheumatic drug for ReA yet.

METHODS

Fifty consecutive patients of ReA, defined by Braun criteria, refractory to NSAIDs were included, with 25 in each group (Sulfasalazine group, tofacitinib group). Forty-six patients completed the study. The primary endpoint was DAREA (Disease Activity Index for the Assessment of Reactive Arthritis) at week 12 between the two groups. Complete response (CR), partial response (PR) and no response (NR) were defined based on DAREA of ≤ 5, 6-10, and > 10, respectively. Secondary endpoints were pain VAS, ESR, CRP, BASFI, MASES, and ASDAS-CRP.

RESULTS

Of the 46 patients who completed the study, 70% were males, with HLA-B27 positivity in 65%. Twenty-one received sulfasalazine and 25, tofacitinib. The median DAREA at 12 weeks [3.35 (IQR: 2.77-9.18) vs. 3.05 (IQR: 2.69, 8.45), respectively)] was comparable between the two groups (p = 0.545). The decline in CRP, ESR, and DAREA was quicker in the tofacitinib group (by week 4). Change from baseline to 12 weeks in DAREA and the secondary endpoints was statistically significant within both groups (p < 0.001). 25% of patients in the tofacitinib group and 18.2% in the sulfasalazine group had NR. There were no serious adverse events in either group by week 12.

CONCLUSION

Sulfasalazine and tofacitinib showed comparable effectiveness and safety in NSAID-refractory ReA at 12 weeks, with tofacitinib exhibiting a more rapid onset of therapeutic response.