Psoriatic arthritis (PsA) places a great burden on sufferers and many of them do not respond satisfactorily to the treatments available to date [2]. Now patients with moderate to severe PsA can benefit from an additional effective and tolerable biologic therapy option [1].
Of the 1 to 3% of people suffering from psoriasis in Switzerland, about one in three is also affected by PsA [2, 3]. Typical clinical manifestations of chronic inflammatory systemic disease include arthritis, enthesitis, dactylitis, axial symptoms, and skin and nail psoriasis [4]. If PsA progresses unchecked, it can lead to joint destruction and consequent disability and increased risk of mortality. Frequently occurring concomitant diseases, such as cardiovascular disease, metabolic syndrome, obesity, diabetes, or psychiatric disorders, further impair the physical functionality and quality of life of those affected [2]. Risankizumab (Skyrizi®) has offered an additional therapeutic option since March 17, 2022 [1].
Indication expansion of risankizumab [1]
Nearly three years after its approval in moderate-to-severe plaque psoriasis in April 2019, risankizumab (150 mg) can now be used as monotherapy or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs) to treat adults with active PsA who have had an inadequate response or intolerance to one or more DMARDs [1, 5]. One of the features of the selective IL-23 inhibitor is a patient-friendly 3-month treatment interval after 2 initial injections at weeks 0 and 4 [1, 6]. Its long-term efficacy and beneficial and stable safety profile in psoriasis have been demonstrated in multiple Phase III studies [6-9]. The results of the randomized, placebo-controlled, phase III studies KEEPsAKE 1 and 2 [2, 4] show that risankizumab can also positively influence the course of the disease in patients with active PsA.
Proven efficacy and good tolerability in PsA. [2, 4]
In KEEPsAKE 1 and 2, a total of 1408 adult PsA patients with inadequate response or intolerance to conventional synthetic (cs) DMARDs (KEEPsAKE 1) and/or biological (b) DMARDs (KEEPsAKE 2) randomized to 24 weeks of double-blind treatment with risankizumab (150 mg) or placebo. In the subsequent open-label extension (OLE), all patients received risankizumab. After 24 weeks, significantly more patients achieved the primary endpoint of a 20% response according to the American College of Rheumatology criteria (ACR 20) with risankizumab than with placebo in both studies(Table). Significantly better results were also obtained in the risankizumab arm with regard to ACR 50 and ACR 70 response and improvement in enthesitis, dactylitis, fatigue, and physical functionality [2, 4]. According to recent data presented at the 2021 EADV Congress, the efficacy of risankizumab in OLE continued to increase numerically. For example, the ACR 20 response rate in patients continuously treated with risankizumab at 52 weeks was 70.0% in KEEPsAKE 1 and 58.5% in KEEPsAKE 2, which included patients with inadequate response to previous bDMARDs [10]. Overall, risankizumab was well tolerated and the safety profile was comparable to that observed in patients with psoriasis [2, 4].
Table: Response of patients with active psoriatic arthritis taking RISA at 24 weeks in the PBO-controlled, randomized phase III KEEPsAKE 1 and 2 trials. Patients in KEEPsAKE 1 had previously responded inadequately to or failed to tolerate ≥ 1 csDMARDs. Patients in KEEPsAKE 2 had previously responded inadequately to or failed to tolerate ≤ 2 bDMARDs and/or ≥ 1 csDMARD. Non-responder imputation (NRI) with multiple imputations if data are missing due to COVID-19, or NRI if no data are missing due to COVID-19. *p<0.05; **p<0.01; ***p< 0.001.
◾ Defined as Leeds Enthesitis Index (LEI)=0 in patients with LEI>0 at baseline . ◽ Defined as Leeds Dactylitis Index (LDI)=0 in patients with LDI>0 at baseline. RISA: 150 mg risankizumab at weeks 0, 4, and 16; PBO: placebo; ACR 20/50/70: 20/50/70% improvement in American College of Rheumatology criteria; HAQ-DI: Health Assessment Questionnaire-Disability Index; FACIT-Fatigue: Functional Assessment of Chronic Illness Therapy Fatigue Questionnaire. Adapted from [2, 4]
Conclusion
The indication expansion of risankizumab in March 2022 now allows adult patients with active PsA to benefit from this long-term effective treatment option with a stable safety profile and patient-friendly use [1, 6]. As shown by the results of KEEPsAKE 1 and 2, treatment with the IL-23 inhibitor can significantly alleviate PsA-associated symptoms [2, 4].
Literature
The references can be requested by professionals at medinfo.ch@abbvie.com.
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Brief technical information Skyrizi®
CH-SKZD-220042_03/2022
