Issue #7, October 2021
Welcome back to The Surface, a feature of the PSOLVE+ community. This month we feature five recent publications with high clinical relevance for Canadian dermatologists. View archived issues of The Surface at psolve.org/the-surface.
Concomitant PsA and PsO results from the EXCEED study
Second-generation biologics have demonstrated increased efficacy compared to TNF inhibitors in the treatment of plaque psoriasis (PsO), however the relative efficacy in co-morbid psoriatic arthritis (PsA) is less clear. The EXCEED study compared the IL-17A inhibitor secukinumab to the TNF inhibitor adalimumab in biologic-naïve patients with PsA. The primary analysis of this monotherapy study was published in 2020, with the current publication focusing on the prespecified subset of patients with concomitant moderate-to-severe PsO.
Patients received secukinumab 300mg at baseline, weeks 1-4, then q4w until week 48; or citrate-free adalimumab 40mg q2w from baseline to week 48. Placebo injections were given to maintain blinding. Of the 853 patients enrolled in the trial, there were 211 in the PsO subset.
ACR 20 responses at week 52 were 76.4% vs 68.3%, slightly favoring secukinumab without reaching statistical significance (OR = 1.53, 95% CI 0.83-2.83). PASI 90 responses at week 52 were 68.6% vs 41.7%, favoring secukinumab (P < 0.001). The composite endpoint of ACR 50 plus PASI 100 was observed in 28.2% of secukinumab patients and 17.7% of adalimumab patients (P = 0.06). Other endpoints were consistent with these results, with rheumatology measures numerically favoring secukinumab over adalimumab. Fewer patients discontinued secukinumab compared to adalimumab (5.5% vs 17.8%). Secukinumab offers a comprehensive biologic treatment to manage the features of concomitant PsO and PsA.
Read more: [Sosido link] Gottlieb AB, Merola JF, Reich K, et al. Efficacy of secukinumab and adalimumab in patients with psoriatic arthritis and concomitant moderate-to-severe plaque psoriasis: results from EXCEED, a randomized, double-blind head-to-head monotherapy study [published online ahead of print, 2021 Apr 29]. Br J Dermatol. 2021;10.1111/bjd.20413. doi:10.1111/bjd.20413
Risk of drug exposure in PsO patients on COVID-19 outcomes in France
Penso and colleagues conducted a retrospective, national cohort study of COVID-19 outcomes in French PsO patients during the first and second waves of the pandemic. Patients were included if they had been diagnosed with PsO between 2008-2019 and had accessed healthcare within the previous 12 months. Over 1.3 million patients were included in the cohort. During the first wave, 3871 of these patients were hospitalized for COVID-19, and 759 died in hospital due to COVID-19. During the second wave, 3603 were hospitalized and 686 died.
Both unadjusted and inverse probability of treatment weighting Cox analysis revealed that the risk of hospitalization was higher in patients with exposure to topicals (n = 321,837) or non-biologics (n = 49,459) during both waves of the pandemic compared to patient with no exposure to PsO medications
(923,018). There was no association between hospitalization and exposure to biologics (n = 31,998) during the first wave, but there was an association found during the second wave, perhaps due to patients more effectively self-isolating during the early days of the pandemic. None of the exposures was associated with increased in-hospital mortality from COVID-19. The mortality results support maintaining systemic treatment during the pandemic, including with biologic agents.
Read more: [Sosido link] Penso L, Dray-Spira R, Weill A, Zureik M, Sbidian E. Psoriasis-related treatment exposure and hospitalization or in-hospital mortality due to COVID-19 during the first and second wave of the pandemic: cohort study of 1 326 312 patients in France [published online ahead of print, 2021 Jul 26]. Br J Dermatol. 2021;10.1111/bjd.20659. doi:10.1111/bjd.20659
Treatment of PsO and the natural history of PsA
The risk factors for development of PsA in PsO patients are not fully elucidated, however models suggest that chronic skin inflammation expands into the synovio-entheseal tissues, and that subclinical enthesitis might be a risk factor in PsO patients. Patient records from a university hospital were retrospectively analyzed for the effect of PsO treatments on the development of PsA. The study included 1,719 patients with PsO and a total of 14,721 patient/years.
The risk of developing PsA in patients with PsO treated with biologics was significantly lower compared with topicals (incidence rate ratio (IRR)=0.26; 95% CI 0.03 to 0.94; p=0.0111), but not compared with conventional DMARDs (IRR=0.35; 95% CI 0.035 to 1.96; p=0.1007). Regression analysis showed that male sex, nail involvement and higher body mass index were associated with increased risk of developing PsA, while biologics use was protective (HR: 0.19; 95% CI 0.05 to 0.81). These results suggest that managing the skin inflammation with biologics can have a positive effect on the natural history of PsA.
Read more: [Sosido link] Acosta Felquer ML, LoGiudice L, Galimberti ML, Rosa J, Mazzuoccolo L, Soriano ER. Treating the skin with biologics in patients with psoriasis decreases the incidence of psoriatic arthritis [published online ahead of print, 2021 Jul 19]. Ann Rheum Dis. 2021;annrheumdis-2021-220865. doi:10.1136/annrheumdis-2021-220865
PASI-HD – a solution for BSA <10%
Papp and colleagues propose a new measure to be used in assessing PsO disease severity and clinical trials, the Psoriasis Area and Severity Index-high discrimination (PASI-HD). Using PASI, if the affected body surface area (BSA) is < 10%, a non-granular score of 1 is applied regardless of the actual extent of affected area. The PASI-HD generates a linear score in these cases, while maintaining the anatomical component of the PASI. To calculate the PASI-HD, small areas of psoriasis can be estimated using the thumb (0.1% of BSA), thumb nail (0.02%), and fifth-finger nail (0.01%). In clinical trials, PASI-HD will more precisely capture disease flaring from and within areas with < 10% involvement.
Read more: [Sosido link] Papp KA, Lebwohl MG, Kircik LH, et al. The Proposed PASI-HD Provides More Precise Assessment of Plaque Psoriasis Severity in Anatomical Regions with a Low Area Score. Dermatol Ther (Heidelb). 2021;11(4):1079-1083. doi:10.1007/s13555-021-00572-2
Survey on the potential impact of a biomarker patch in PsO treatment selection
Strober and colleagues designed a survey investigating trial-and-error to select biologic therapy for PsO patients and how incorporation of a predictive biomarker patch could impact selection. Forty-three dermatologists completed the web-based survey. Overall, they reported that over 75% of their psoriasis patients were being treated with biologics.
The top factors influencing first-line biologic selection were response rates (88% of respondents), presence of PsA (86%), comorbidities (82%), side effects (81%), and formulary coverage (77%). Patients are typically assessed for non-response at 12 weeks and switched out of class if required. Participants were required to view a webinar describing response rates for biologics, loss of response over time, estimated costs to society relating to lack of/loss of therapeutic response, and an overview of a proprietary dermal patch designed to use mRNA captured from plaques to predict biologic response. After viewing this information, 93% indicated they would use the results of such a device to select a firstline therapy. It should be noted there were no references to the specificity or sensitivity of the dermal patch mentioned in the publication; and that both the survey and rapid publication of results were supported by the company developing the patch.
Read more: [Sosido link] Strober B, Pariser D, Deren-Lewis A, Dickerson TJ, Lebwohl M, Menter A. A Survey of Community Dermatologists Reveals the Unnecessary Impact of Trial-and-Error Behavior on the Psoriasis Biologic Treatment Paradigm [published online ahead of print, 2021 Jul 18]. Dermatol Ther (Heidelb). 2021;10.1007/s13555-021-00573-1. doi:10.1007/s13555-021-00573-1
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