Tofacitinib provides sustained dactylitis improvement in psoriatic arthritis
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Patients with psoriatic arthritis who receive tofacitinib demonstrate “sustained improvements” in dactylitis compared with those who did not receive tofacitinib, according to data published in BMC Rheumatology.
“Dactylitis is considered a core domain of musculoskeletal symptoms in PsA and is important for both patients and physicians when developing treatment strategies,” Ana-Maria Orbai, MD, MHS, of the Johns Hopkins University School of Medicine, and colleagues wrote. “However, effective therapies to treat dactylitis in patients with PsA are still needed.”
To evaluate the impact of tofacitinib (Xeljanz, Pfizer) on dactylitis and patient-reported outcomes in PsA, Orbai and colleagues conducted an ad hoc analysis of data from two phase 3 trials. In the first trial, OPAL Broaden, patients with PsA who demonstrated a suboptimal response to conventional synthetic disease-modifying antirheumatic drugs (DMARDs) received tofacitinib 5 mg or 10 mg, or placebo, twice daily for 3 months. One cohort in this study also received adalimumab (Humira, AbbVie) 40 mg injections every 2 weeks. Meanwhile, in OPAL Beyond, patients received tofacitinib 5 mg or 10 mg twice daily, or placebo, for 3 months.
Patients were categorized at baseline based on the presence of dactylitis in hands or feet. The number of impacted digits was evaluated by a blinded evaluator, and each digit with dactylitis was scored on a scale of 0 to three, denoting no to extreme tenderness, according to the researchers.
Endpoints for this analysis included the number of digits exhibiting dactylitis for each patient, as well as the proportion of patients with dactylitis at months 1, 3 and 6. The change from baseline in dactylitis severity score in patients with dactylitis at baseline, and the development of dactylitis in those with no dactylitis at baseline were also evaluated.
The researchers additionally assessed dactylitis scores, patient-reported outcomes at months 1, 3 and 6. These evaluations included the Health Assessment Questionnaire-Disability Index scores, the Functional Assessment of Chronic Illness Therapy-Fatigue total score and Work Limitations Questionnaire.
The analysis included 373 patients with a baseline dactylitis severity score (DSS) greater than 0, and 337 patients with a DSS of 0. Patients with a DSS of more than 0 demonstrated greater improvement in DSS from month 1 when receiving tofacitinib, compared with patients receiving placebo, according to the researchers.
In addition, patients receiving either dose of tofacitinib experienced a lower presence of dactylitis at 6 months. In patients with a DSS greater than 0, the presence of dactylitis was 15% or less for all digits. For patients with a DSS of zero, the presence of dactylitis was less than 2% for all digits at 6 months, the authors wrote.
“This post-hoc analysis of pooled data from two phase III studies, treatment with tofacitinib resulted in lasting improvements in dactylitis, with minimal emergence of new dactylitis up to month 6, irrespective of dactylitis location,” Orbai and colleagues wrote. “These results suggest that tofacitinib treatment may benefit those patients with PsA experiencing dactylitis, thus further supporting the use of tofacitinib as a treatment for PsA. Further analyses of data collected over longer time periods are required to further assess the effects of tofacitinib on dactylitis in patients with PsA.”
References:
Orbai AM, et al. Ann Rheum Dis. 2017;doi:10.1136/annrheumdis-2016-210242
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