Tofacitinib was beneficial for dactylitis in patients with psoriatic arthritis (PsA) who demonstrated sustained improvements after 6 months, according to study findings published in BMC Rheumatology.

Dactylitis is a painful inflammatory condition characterized by swelling in the phalangeal joints and tendons that can occur in patients with PsA. Patients with PsA with an inadequate response to tumor necrosis factor inhibitors (TNFi) may receive treatment with an oral Janus kinase inhibitor such as tofacitinib.

Researchers at Johns Hopkins conducted a post hoc analysis pooling data from 2 phase 3 studies to analyze the effects of tofacitinib on dactylitis in PsA.


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In the OPAL Beyond and OPAL Broaden trials (ClinicalTrials.gov Identifiers: NCT01877668 and NCT01882439, respectively), patients with active PsA received tofacitinib at 5 or 10 mg twice a day compared with placebo or subcutaneous injections of 40 mg of adalimumab every 2 weeks.

The researchers used the Dactylitis Severity Score (DSS) to confirm the presence (DSS>0) or absence (DSS=0) of dactylitis in patients with PsA.

The effects of tofacitinib were determined using the following outcome measures:

  • DSS
  • Multiple components of the Short Form-36 Health Survey (SF-36)
  • Psoriatic Arthritis Disease Activity Score (PASDAS),
  • Health Assessment Questionnaire-Disability Index (HAQ-DI),
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
  • Arthritis pain
  • Work Limitations Questionnaire (WLQ)

Of a total of 710 patients with PsA who were included in the analysis, 373 had dactylitis. After 1 month of treatment with tofacitinib, patients receiving 10 mg vs those receiving placebo showed improvements in severity of dactylitis on the DSS.

Tofacitinib was shown to improve the presence and severity of symptoms of dactylitis. After 6 months, dactylitis occurred in up to 15% of patients who received 5 or 10 mg of tofacitinib. At baseline, dactylitis was present in 35.4% and 38.4% of patients who were receiving 5 and 10 mg of tofacitinib, respectively.

However, the researchers noted that tofacitinib vs placebo did not prevent onset of dactylitis. After 6 months of tofacitinib treatment, dactylitis occurred in fewer than 2% of patients without dactylitis at baseline although similar rates also occurred in the placebo group as well.

Tofacitinib vs placebo also reduced overall PsA disease activity, as seen on PASDAS, after 3 months of treatment. Dactylitis location did not impact changes in patient-reported outcomes compared with baseline measurements.

Study limitations included the post hoc design using pooled data, the small number of patients in the dactylitis groups, lack of formal statistical testing to assess changes from baseline using the patient-reported outcome measures, and short-term follow-up of only 6 months of tofacitinib treatment. Additionally, the method used to clinically assess for dactylitis is known to have poor inter- and intraobserver reliability.

“Dactylitis should be considered when treatment options are being evaluated for PsA,” the study authors said. “Tofacitinib resulted in sustained improvements in dactylitis irrespective of location, with minimal emergence of new dactylitis.”

Reference

Orbai AM, Mease PJ, Helliwell PS, et al. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022;6(1):68. doi:10.1186/s41927-022-00298-4