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Take a look at a selection of our recent media coverage:
17th March 2022
Psoriasis patients report using more analgesics than members of the general public without the disease and this is largely because of an increased level of joint pain. This was the finding of a study by researchers from the Department of Dermatology and Allergy, Copenhagen University Hospitale-Herlev and Gentofte Hospital, Copenhagen, Denmark.
Psoriasis is best defined as a chronic, immune-mediated inflammatory disease and which varies in prevalence around the world ranging from 30.3 per 100 000 person years to 321.0 per 100 000 person years. Although psoriasis presents clinically as an inflammatory skin condition, it has become recognised that 1 in 4 patients with psoriasis also have an associated and painful inflammatory joint condition, termed psoriatic arthritis. While the dry, flaky skin elevated psoriatic plaques are often highly pruritic, over recent years, it has become more apparent that skin pain is a frequently reported and bothersome symptom among people with psoriasis. Indeed, one retrospective analysis of over 4,500 psoriasis patients clearly showed how patients experience pain, finding that two-thirds were co-prescribed non-steroidal anti-inflammatory drugs, 59.5% other analgesics and 45.9% opioids.
What remains unclear however, is why people with psoriasis take analgesics and so for the present study, the Danish team turned to data contained within the Danish Skin Cohort to assess disease burden and the use of analgesics among psoriasis patients with and without psoriatic arthritis (PsA) and for comparative purposes, included a control group without either condition.
Psoriasis patients and use of analgesics
A total of 3169 patients with psoriasis only and a mean age of 59 years (55.8% female) were included along side, 3490 controls and 847 individuals with both psoriasis and PsA.
The median skin and joint pain in the general population was 0 and 2 respectively. In contrast, moderate-to-severe skin pain was reported by 30% of those with PsA and 21% with psoriasis alone (p < 0.0001). In addition, moderate-to-severe joint pain was reported by 69% of those with PsA and 45% of those with only psoriasis (p < 0.0001).
The use of opioid analgesics in the last 12 months was reported by 9% of the control group, 14.2% of those with psoriasis alone but 22.7% of those with both psoriasis and PsA. Using multivariable regression, the authors calculated that only joint pain was significantly associated with the use of analgesics (odds ratio, OR = 3.72, 95% CI 2.69 – 5.14, p < 0.001).
The authors concluded that physicians should pay increased attention to those with psoriasis who report any joint pain in order to further improve their clinical management.
Loft N et al. Disease burden, symptoms, and use of analgesics in patients with psoriasis with or without psoriatic arthritis: A cross-sectional study J Am Acad Dermatol 2022
2nd December 2021
Skyrizi (risankizumab) has been approved by the UK regulator, the MHRA, for the use in adults with active psoriatic arthritis. This follows the EMA approval earlier this month.
The Summary of Product Characteristics (SPC) of the drug has been updated to reflect this change, stating that it is indicated either ‘alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).’
Skyrizi is a monoclonal antibody and blocks the action of interleukin 23, (IL-23), which is believed to play an important role in psoriatic arthritis. The approved dose for risankizumab is 150mg, administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter.
The approval was based on data from two clinical studies, KEEPsAKE-1 and KEEPsAKE-2 and although both of the trials included patients with moderate to severe PsA, the populations were slightly different. For example, KEEPsAKE-1 included patients who had with an inadequate respond to one or more DMARDs whereas KEEPsAKE-2 recruited those with an inadequate response to other biologicals. However, both studies had the same primary endpoint of an ACR20 response at week 24. In addition, secondary outcomes included improvements in several clinical manifestations of psoriatic arthritis such as physical functioning (as assessed by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) and both the primary and secondary endpoints were assessed after 24 weeks of therapy.
In KEEPsAKE-1 57.3% of patients receiving risankizumab achieved the primary endpoint at week 24 compared to 33.5% in the placebo group (p < 0.001). Similarly, in KEEPsAKE 2, 51.3% achieved the primary endpoint compared with 26.5% in the placebo arm (P< 0.001).
There were also significantly greater improvements in the secondary outcomes for risankizumab-treated patients. For example, in KEEPsAKE-1, there was a -0.31 change in HAQ-DI compared to -0.11 (placebo) and in KEEPsAKE 2, a change of -0.22, compared to -0.05 in the placebo group (for both differences, p <0.001).
22nd November 2021
The European Medicines Agency (EMA) has approved the use of risankizumab (brand name Skyrizi) for the treatment of patients with active psoriatic arthritis (PsA) who have failed to adequately response to one or more disease modifying anti-rheumatic drugs (DMARDs) or who are intolerant to DMARDs.
Psoriatic arthritis is an inflammatory arthritis affecting the joints and connective tissue which is associated with psoriasis and which is present on the skin or nails. While the prevalence of psoriasis in the general population is low, at around 3%, at least 20% of psoriasis patients have PsA which is a progressive disease that ranges from mild synovitis to severe erosive arthropathy. Sufferers of PsA experience joint inflammation which causes swelling and pain and which has a negative impact on their quality of life.
The treatment of PsA starts with non-steroidal anti-inflammatories and as the disease progresses, escalates to oral corticosteroids, DMARDs and finally biologic agents. There are currently several biologics approved for the management of PsA including ixekizumab and guselkumab. Skyrizi was previously approved by the EMA in 2019 for the treatment of plaque psoriasis but that has been extended to include PsA.
The EMA approval of Skyrizi (risankizumab) was based the findings of two Phase III clinical trials, KEEPsAKE-1 and KEEPsAKE-2. Both trials were placebo-controlled trials in patients with moderate to severe PsA although KEEPsAKE-1 included patients with an inadequate respond to one or more DMARDs whereas KEEPsAKE-2 recruited those with an inadequate response to other biologicals. In both trials patients received skyrizi at subcutaneous dose of 150 mg and the primary outcome for both studies was the ‘percentage of Participants Achieving at least 20% Improvement in American College of Rheumatology (ACR20)‘.
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
In both trials, the ACR20 response was set as the primary endpoint and assessed after 24 weeks. Secondary endpoints included the Health assessment questionnaire disability index (HAD-DI), which represents a measure of physical function and the proportion of patients achieving minimal disease activity (MDA).
In KEEPsAKE-1 (KS1) and KEEPsAKE-2 (KS2), 57.3% and 51.3% of patients respectively, given risankizumab achieved the primary endpoint compared to 33.5% and 26.5% receiving placebo (p<0.001).
Similarly, improvements in HAQ-DI of -0.31 (KSI) and -0.22 (KS2) compared with -0.11 and -0.05, in the respective placebo groups was seen at week 24 (p<0.001). Finally, 25% (KS1) and 25.6% (KS2) of Skyrizi patients achieved MDA, compared to 10.2% (KS1) and 11.4% (KS2) of those on placebo (p<0.001).
In terms of safety, serious adverse events occurred in 2.5% (KS1) and 4% (KS2) of patients given Skyrizi although this was comparable to the placebo rate (3.7% and 5.5%, KSI and KS2).
According to the EMA approval, Skyrizi can be used either alone or in combination with methotrexate.
Source. Abbvie press release. 17th November 2021