Risankizumab effectively treats patients with active psoriatic arthritis (PsA), and improves functional status and quality of life compared with placebo, according to findings published in Journal of the European Academy of Dermatology and Venereology.
Researchers conducted 2 randomized, placebo-controlled phase 3 clinical trials (KEEPsAKE-1 and -2) that compared the responses of patients with PsA who received risankizumab 150 mg versus placebo for 24 weeks. Beginning at week 24, all patients received risankizumab 150 mg until week 52.
The researchers used the Patient’s Global Assessment of Disease Activity (PtGA), the Patient’s Assessment of Pain, the Health Assessment Questionnaire-Disability Index (HAQ-DI), the Short-Form 36 Physical and Mental Component Summary scores (PCS and MCS, respectively), the 5-Level EQ-5D (EQ-5D-5L), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), and the Work Productivity and Activity Impairment to measure patient response to treatment.
In KEEPsAKE-1, between 54% and 67% of all patients receiving risankizumab achieved minimal clinically important differences (MCIDs) in outcomes measuring physical functioning, overall quality of life, fatigue, pain, and global assessment after 24 weeks compared with the placebo group.
Patients in the risankizumab group scored better than those in the placebo group in the following measures:
- HAQ-DI (odds ratio [OR]: 2.7; 95% confidence interval [CI], 2.0-3.6; P <.01);
- EQ-5D-5L (OR: 2.2; 95% CI, 1.7-2.9; P <.01);
- Both the SF-36 PCS (OR: 2.0; 95% CI, 1.5-2.6; P <.001) and MCS (OR: 1.5; 95% CI, 1.2-2.0; P <.01);
- FACIT-Fatigue (OR: 1.9; 95% CI, 1.4-2.5; P <.001);
- Patient’s Assessment of Pain (OR: 2.2; 95% CI, 1.6-2.9; P <.001); and
- PtGA (OR: 2.0; 95% CI, 1.5-2.7; P <.001).
In KEEPsAKE-2, the researchers observed similar trends. Between 59% and 76% of all patients treated with risankizumab achieved MCIDs after 52 weeks.
Limitations of the study include possible recall bias on the patient-reported outcomes measures and a lack of consideration for regional political policies or socioeconomic factors influencing the results.
The study authors conclude, “These studies demonstrated the robust beneficial impact of [risankizumab] treatment in patients with active PsA. A majority of patients reported MCID in most [patient-reported outcomes] as early as week 24 and continued improving through week 52.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Kristensen LE, Soliman AM, Papp K, Barcomb L, Eldred A, Östör A. The effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: Results from KEEPsAKE 1 and 2. J Eur Acad Dermatol Venereol. Published online August 3, 2022. doi:10.1111/jdv.18475