Hervé Bachelez, MD, PhD

Credit: International Psoriasis Council

Tofacitinib may lead to patients with psoriasis and history of psoriatic arthritis (PsA) to see improvement by Week 16 in disease, joint pain, pruritus, morning stiffness, and depressive symptoms, according to new findings, with doses being 5 and 10 mg twice per-day.¹

These findings were the conclusion of a recent research letter in which investigators assessed tofacitinib among this specific patient population, primarily due to the known worse health outcomes observed among psoriasis patients with PsA and joint/skin symptoms as opposed to only joint symptoms.²

This new research was led by Hervé Bachelez, MD, PhD, from the department of dermatology at AP-HP Hôpital St. Louis in Paris, France.

“Using pooled data from two global/52-week/Phase III studies, OPT Pivotal 1 and 2…this post hoc analysis examined the efficacy/PROs/safety of tofacitinib in patients with moderate to severe plaque psoriasis and history of PsA, and explored the role of itch/joint pain/morning stiffness in reducing depressive symptoms,” Bachelez and colleagues wrote.

Background and Findings

The investigators explored the use of the oral Janus kinase (JAK) inhibitor in a pooled analysis of data drawn from two phase 3 studies, OPT Pivotal 1 and 2. These studies spanned 52 weeks and were carried out globally.

The research team used a post-hoc analysis of this data to assess the patient-reported outcomes (PROs), efficacy, and safety profile of tofacitinib in those with moderate-to-severe psoriasis and a history of psoriatic arthritis.

The team randomized subjects in their research to be given tofacitinib 5 or 10 mg twice-per-day or a placebo, having the placebo-treated subjects switching to the drug at the 16-week mark. They looked into the effects of joint pain, itch, and morning stiffness on helping to mitigate symptoms of depression.

By 16 weeks, those in the 5 and 10 mg BID treatment arms were shown by the team to have major improvements in Itch Severity Item (ISI) scores, rates of response in their Psoriasis Area and Severity Index (PASI)75/PASI90 scores, and diminished joint pain as opposed to subjects in the placebo arm.

The investigators also noted that there was a large portion of participants in the treatment arm who ended up achieving a Hospital Anxiety and Depression Scale Depression (HADS-D) subscale score <8 by the 16-week mark, suggesting there were reductions in their depressive symptoms.

The improvements the research team observed were shown to be generally sustained through to Week 52, and the team’s mediation analysis suggested that mitigation of pruritus played a substantial role in the decreased symptoms of depression among those treated with the drug. The team’s assessment of safety led to a profile consistent with that of previously-observed adverse events (AEs).

Overall, the investigators concluded that the pooled OPT Pivotal 1 and 2 trial data indicated improvements in itch, skin condition, morning stiffness, pain in joints, and mental health compared to those given a placebo by Week 16 and that these were sustained through to 52 weeks.

The reduction in itch emerged as the key mediator in alleviating mental health struggles, the team noted, and the findings may contribute insights for clinical decision-making as well as scientific understanding, especially when it comes to management of PsA among patients with joint and skin manifestations.

“As patients with PsA experiencing joint/skin symptoms use more healthcare resources than patients with joint symptoms alone, these data can further inform clinical practice/scientific community,” they concluded.

References

1. ^{Bachelez, H., Griffiths, C.E.M., Papp, K.A., Hall, S., Merola, J.F., Feldman, S.R., Khraishi, M., Tan, H., Fallon, L., Cappelleri, J.C., Bushmakin, A.G. and Young, P. (2024), Tofacitinib efficacy, patient-reported outcomes and safety in patients with psoriasis and a medical history of psoriatic arthritis: Pooled analysis of two Phase III studies. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.19701.}
2. ^{de Vlam K, Merola JF, Birt JA, Sandoval DM, Lobosco S, Moon R, et al. Skin involvement in psoriatic arthritis worsens overall disease activity, patient-reported outcomes, and increases healthcare resource utilization: an observational, cross-sectional study. Rheumatol Ther. 2018; 5: 423–436.}