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AbbVie have presented results from new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, evaluating Skyrizi (risankizumab) in adults with active psoriatic arthritis for one year.
Source: abbvie.com
Skyrizi (risankizumab)
Quote:
AbbVie today presented results from new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, evaluating risankizumab (SKYRIZI®, 150 mg) in adults with active psoriatic arthritis for one year (52 weeks). These results were featured during the "Late Breaking News, Reviews and Updates" session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.
KEEPsAKE-1 included adult patients with active psoriatic arthritis who responded inadequately to non-biologic disease-modifying anti-rheumatic drugs (DMARDs). KEEPsAKE-2 included adult patients with active psoriatic arthritis who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). In the first phase of the studies (Period 1), patients were randomized to risankizumab or placebo until week 24. At week 24, the open label extension (Period 2) began, and all patients were treated with risankizumab.
The new long-term data from the open-label extension period showed that 70 and 58 percent of patients initially treated with risankizumab achieved American College of Rheumatology 20 (ACR20) response in KEEPsAKE-1 and KEEPsAKE-2 respectively at one year, where patients with missing data were categorized as non-responders. Among patients initially treated with risankizumab, 43 percent in KEEPsAKE-1 and 32 percent in KEEPsAKE-2 achieved ACR50 response, and 26 percent in KEEPsAKE-1 and 17 percent in KEEPsAKE-2 achieved ACR70 response at one year.
Additionally, at one year, 68 and 64 percent of patients initially treated with risankizumab and with a body surface area ≥3 percent at baseline achieved a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) in KEEPsAKE-1 and KEEPsAKE-2, respectively.
"Millions of people still suffer daily with symptoms of psoriatic arthritis, driving us to advance treatment options for these patients," said Thomas Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "These new analyses at one year support the potential of risankizumab to maintain improvements across multiple manifestations of psoriatic arthritis."
In terms of improvement in physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]), patients initially randomized to risankizumab reported mean reduction (i.e., improvement) of 0.41 and 0.26 from baseline in HAQ-DI score for KEEPsAKE-1 and KEEPsAKE-2, respectively, at week 52.
In addition, pooled results from KEEPsAKE-1 and KEEPsAKE-2 showed that 76 and 55 percent of patients achieved the resolution of dactylitis and resolution of enthesitis, respectively, at week 52.
"Dactylitis is a common symptom in psoriatic arthritis that can cause severe swelling in the fingers and toes that result in everyday tasks becoming difficult," said Lars Erik Kristensen, M.D., Ph.D., consultant and head of science at the Parker Institute Copenhagen Denmark, associate professor, Lund Sweden, SUS University Hospital. "These results provide important insights on how both biologic-naïve and experienced patients may benefit from treatment with risankizumab."
Both KEEPsAKE-1 and KEEPsAKE-2 demonstrated consistent long-term safety profiles with those shared at week 24, with no new safety findings observed from week 24 through week 52.1 Serious treatment-emergent adverse events (TEAE) occurred at 7.4 events/100 patient-years (E/100 PYs) and 9.4 E/100 PYs in KEEPsAKE-1 and KEEPsAKE-2, respectively. Rates of serious infections in KEEPsAKE-1 and KEEPsAKE-2 were 2.8 and 2.0 E/100 PYs, respectively. The rates of TEAEs leading to discontinuation of the study drug in KEEPsAKE-1 was 2.3 E/100 PYs and 1.6 E/100 PYs in KEEPsAKE-2.1 In KEEPsAKE-1, there were two deaths and both were not related to the study drug per investigator. There were no deaths reported in KEEPsAKE-2.1 In KEEPsAKE-2, three major adverse cardiac events (MACE) were reported, which were not related to the study drug per the investigator. No MACE were reported in KEEPsAKE-1.
In January 2021, AbbVie announced positive top-line results from the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, showing that risankizumab (150 mg) achieved the primary endpoint of ACR20 response versus placebo during the 24-week double-blinded, placebo-controlled, parallel-group period (period 1).
Source: abbvie.com
Skyrizi (risankizumab)
Hope it becomes available here soon
