Tofacitinib as AA Treatment Has High Drug Survival Rates, Manageable Side Effects

Worried woman looking at scalp | Image Credit: Pormezz - stock.adobe.com

Patients with AA participated in a single center, retrospective, observational cohort study and exhibited sustainable efficacy, safety, and satisfactory drug survival rates after taking tofacitinib (Xeljanz).

The Department of Dermatology at a hospital in Changsha, China led the study from February 2021 until December 2022. The study goal was to analyze the drug survival, efficacy, and safety in tofacitinib, an alternative treatment for refractory AA cases. The Chinese Food and Drug Administration approved Xeljanz in March 2017 to treat inflammatory diseases.

A total of 126 patients were observed. Most participants were female (61.9%) and received treatment for an average of 23 weeks. The median age was 25.5 years. Of the 126 patients, 71 included the general AA group whereas 55 made up the refractory AA group who typically endure harsher prognosis, with higher rates of therapeutic failures or relapses.

The median duration of all-cause survival was 44 weeks (95% CI, 36.3-51.7), and the all-cause retention rate came to 90%, 66.4%, and 42.3% at 12, 24, and 48 weeks, respectively. The efficacy evaluation was reduced to 80 patients with AA (median age, 26 years; female, 63.8%). Following 6 months of therapy, the complete response (CR) rate was 47.4% for the general group and 21.4% for the refractory group. In total, severe AA cases decreased from 72.5% to 7.5%.

The 126 patients compiled in the drug survival analysis experienced ineffective and adverse events (AEs) over 12, 24, and 48 weeks in 96.7%, 86.4%, and 82.8% of patients with AA, respectively. Discontinuations were mainly due to the attainment of CR or sufficient efficacy (n = 33). Overall, only 2 patients with AEs discontinued the study. It is significant to note the COVID-19 pandemic hindered return visits, drug procurements, and the risk of infections, all contributing to drug discontinuation (n = 8).

During follow-up, 70 patients reported AEs out of the 126-group total. The most common AEs were scalp seborrheic dermatitis/folliculitis (22.2%) and facial acne/acne-like rashes (12.7%). Infection-related AEs were mainly upper respiratory tract infections (10.3%) while dyslipidemia was the most common laboratory-related AE (7.9%). Menstrual disorders, Bell palsy, gastrointestinal symptoms, and headaches were other AEs reported, but only 2 patients experiencing some form of an AE discontinued from the study.

Study results concluded AEs were the only statistically possible predictor for drug survival and discontinuation, uninfluenced by patient demographics or clinical characteristics. A lower risk of discontinuation was reflected in patients who reported AEs upon experiencing them.

Study limitations involve the small sample size, based only on a singular center of clinical data. Patient size decreased by 13 after early-stage follow-up as well.

Larger cohorts conducting long-term janus kinase (JAK) inhibitor treatment has the potential to determine ideal therapy options. The authors concluded, “Further studies on the drug retention rate of other JAK inhibitors in the treatment of AA are needed to investigate the long-term outcomes of different types of JAK inhibitors and provide evidence for treatment options in real-world settings.”

Reference

Huang J, Deng S, Li J, et al. Drug survival and long-term outcome of tofacitinib in patients with alopecia areata: a retrospective study. Acta Derm Venereol. 2023;103:adv13475. doi:10.2340/actadv.v103.13475