Patients taking the JAK inhibitor had better disease activity and immune regulation, hinting at a possible new treatment.
Sjögren’s Disease patients who took oral tofacitinib saw improvements to their disease activity and immune regulation, alongside lower follicular helper T (Tfh) cells and peripheral helper T (Tph) cell levels.
The results suggest that the JAK inhibitor may be a potential new treatment candidate for Sjogren’s patients, according to the Australian, Chinese and US authors.
The researchers undertook two studies, one retrospective and one prospective, to evaluate the changes in disease activity, laboratory test results and effector Tfh and Tph cells.
In the first study, 112 adults with SjD were treated with oral tofacitinib 5mg twice daily for six months. They found the drug improved symptoms, particularly in patients with arthritis, cutaneous involvement and hyperglobulinemia.
“We also noted a significant reduction in IgG, ESR, CRP and C4 levels. The proportion of ESSDAI responders and the degree of improvement in ESSDAI were higher in the high disease activity group than in the moderate and low disease activity groups,” the authors wrote.
The second study included 10 Chinese patients with moderate or high disease activity, defined by an ESSDAI score of at least five. These patients received the same 5mg twice daily dose for 12 months, with assessments at months 0, 1, 3, 6, 9 and 12.
“By the sixth month, there were clinically meaningful and statistically significant reductions in ESSPRI scores from baseline. Additionally, patients receiving tofacitinib experienced substantial decreases in ESSDAI scores at month six, consistent with the findings from our retrospective study,” the authors wrote.
“The higher proportion of patients responding to ESSDAI in the prospective phase 2 trial at six months than in the retrospective study may be related to the higher ESSDAI scores of patients. Moreover, levels of IgG significantly decreased by month six, and the efficacy of tofacitinib remained sustained up to month 12.”
Related
The researchers found several side effects, such as higher liver enzyme levels, small increases in serum creatinine and lower blood cell counts (including white blood cells, neutrophils, lymphocytes and platelets). Some hair loss was also found.
None of the participants withdrew for serious events, but four out of 112 stopped for non-serious events such as headache, slight creatinine elevation, increased blood pressure and chest distress.
“The data gleaned from our investigation imply that tofacitinib’s therapeutic impact on SjD may stem from its ability to regulate Tfh and Tph cells, achieved through the suppression of pSTAT3. These mechanisms may contribute to the potential induction of disease remission.
