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The PASI includes the severity of the three main signs of psoriasis on the skin (redness, scaliness and thickness) weighted by the coverage of the affected body part (legs, body, arms and head) . The PASI score ranges from 0 up to 72 in theory, where a higher score stands for a severer skin involvement of psoriasis. PASI 75 (a 75% improvement in PASI) is usually seen as the clinical end point in RCTs and has even been suggested as treatment goal in clinical practice .
Approved biological agents for psoriasis in Sweden at the time of analysis were adalimumab, etanercept, infliximab and ustekinumab.
Analysis of outcomes in relation to switch was limited to biological-naïve patients that had at least one assessment of PASI, DLQI and/or EQ-5D before and one assessment after switch from conventional systemic treatment to a biological agent. Observations closest in time to switch for each patient were used. The number of patients who had discontinued treatment with biological agents at the follow-up was reported. A Wilcoxon signed rank test was used to determine whether there was a difference in EQ-5D, DLQI and PASI before and after switch to a biological agent. The Wilcoxon signed rank test was used as variables were non-normally distributed and dependent.
The benefit of the biological agent, in terms of change in EQ-5D, was analysed in different subgroups of patients: subgroups of pretreatment PASI and DLQI intervals of ≤10 compared to ≥10, patients with PASI >10 and/or DLQI >10 compared to patients with PASI ≤10 and DLQI ≤10; patients with percentage change of PASI 75 compared to patients who did not achieve PASI 75; subgroups of different clinical characteristics of psoriasis (nail involvement, erythrodermia, palmoplantar non-pustular, general pustular, palmoplantar pustular and acrodermatitis continua suppurativa), and subgroups of first biological agent. The Mann-Whitney U test was used to determine whether there was a significant difference in outcomes between different patient groups.
Sex, age  and psoriatic arthropathy  are known confounders for HRQOL. Therefore, we controlled for these variables in an ordered logit regression analysis with EQ-5D change as the outcome. For the regression analysis, EQ-5D change was divided into 9 intervals of 1 to >0.75, 0.75 to >0.5, 0.5 to >0.25, 0.25 to >0, 0, 1 Efalizumab was withdrawn in 2009 and therefore excluded from analyses.
The numbers of PASI, DLQI and EQ-5D assessments differed between patients, as well as the time between assessments (table 1). About 40% had more than 4 assessments and about 15% had more than 8 assessments. Up to 60% of patients assessed PASI, DLQI and EQ-5D the same day as the biological agent was initiated. 30% had the assessment before switch to a biological agent 2 months before switch and the remaining, about 10%, had the assessment more than 2 months before switch. About 1/3 of patients had the follow-up assessment less than 2 months after switch, 1/3 had it between 2 and 3 months and 1/3 had the follow-up assessment more than 3 months after switch. (Follow-up times differed somewhat between measures where PASI had, on average, shorter and EQ-5D longer follow-up times.)
About 14% of patients had discontinued treatment with biological agents on follow-up, out of whom the majority, about 2/3 of patients, discontinued treatment more than 2 months before the follow-up assessment.
There were statistically significant differences in PASI, DLQI and EQ-5D (p 10 and/or DLQI >10 before switch to a biological agent. One patient had a pretreatment PASI of 67.8, which is explained by the presence of erythroderma. Excluding the patient from analyses only changed results marginally.
Main results: outcomes before and after switch to a biological agent
Box plots of outcomes before and after switch to a biological agent. Box plots illustrate the distribution of PASI (a, n = 261), DLQI (b, n = 251) and EQ-5D (c, n = 229) before and after switch to a biological agent. The ‘box' itself represents the lower quartile, median and upper quartile of data. The ‘whiskers' represent the furthest observation which is within 1.5 interquartile range from the sides of the box. Observations not covered by the whiskers are outliers, marked with a dot in the graph.
The difference in EQ-5D increased with higher PASI and/or DLQI values before switch (table 3).
Subgroup analysis of change in EQ-5D before switch and at follow-up, subgroups based on PASI and DLQI intervals, PASI change intervals, presence of psoriatic arthropathy and PASI >10 and/or DLQI >10
62% of patients had a PASI 50 and 38% had a PASI 75. 20% had a PASI 90. Patients who did not experience a reduction in PASI had limited change in EQ-5D.
There were no statistically significant differences between patients with or without nail involvement, in the change of EQ-5D (p = 0.922), or in EQ-5D, before (p = 0.899) or after switch (p = 0.799). For uncommon clinical characteristics, the general tendency was that patients did not respond as well to biological agents, but results were not statistically significant which is likely to be due to limited sample size. The small sample of patients with erythroderma (n = 10), however, showed a tendency (p = 0.081) of a better EQ-5D change (-0.23).
There were no significant differences in the change of outcomes between different biological agents, which may be due to limited sample size.
The regression analysis with EQ-5D change as outcome variable showed that sex (p = 0.775), age (p = 0.115) and psoriatic arthropathy (p = 0.102) were not statistically significant, whereas PASI (p = 0.017) and DLQI (p 10 and/or DLQI >10 before switch experienced the greatest benefit in HRQOL.
The Swedish national registry PsoReg allowed for an analysis of the effectiveness of biological agents in clinical practice. The strength of this study is the real-world data, which made it possible to analyse benefits in different subgroups of patients. Published RCTs have assessed the efficacy of biological agents in selected trial populations in psoriasis. Our evaluation of real-world effectiveness adds new results in patient groups where characteristics may be different.
Since the study was not protocol driven and there were no mandatory follow-up visits in PsoReg, patients had different follow-up times. Some patients had even discontinued biological treatment on follow-up. This is a weakness which comes with an observational design as these factors, naturally, influenced outcomes; some patients may not have reached the full treatment effect, and some may have had a relapse of disease after discontinuing treatment. Furthermore, as psoriasis is a chronic disease with varying episodes of more or less severity, assessment of outcomes at one point in time may be misleading. Nonetheless, sensitivity analyses with a longer follow-up and excluding patients who had discontinued treatment showed that the main results were robust. However, a positive effect of a longer follow-up time in the sensitivity analyses may be offset due to an increasing number of patients discontinuing treatment.
A recent review study concluded that there is a lack of large-scale real-world studies of psoriasis patients, particularly involving patient utility . Observational studies including utility are mainly limited to cross-sectional analyses . However, a number of RCTs have included EQ-5D. The EQ-5D change was between 0.12 and 0.21 and the DLQI change was 7.7-11.5 with follow-ups between 12 and 54 weeks [4,28,29], compared to changes of 0.12 and 5.9 for EQ-5D and DLQI, respectively, in the present study. The EQ-5D change was in the lower end of previous RCTs, and the DLQI was slightly lower than RCT values. However, DLQI and EQ-5D changes of 2.3-5.7 and 0.09-0.22, respectively, have shown to be the minimum important difference . Our results were within these ranges. In a clinical trial of 50 mg etanercept once weekly, 37.5% of patients achieved PASI 75 after 12 weeks , which was similar to our study. In the clinical trial 71% had PASI 75 at week 24 . Whereas the treatment goal in RCTs is often PASI 75, the treatment goal in clinical practice may be individual for each patient. There is no measure of patient treatment satisfaction available in PsoReg.
There are several reasons why we cannot expect that results in register-based studies match those in RCTs. One previously mentioned reason is different follow-up times; another is differences in patient characteristics. RCTs normally exclude comorbidities, and most trials demand a pretreatment PASI >10. Furthermore, some RCTs exclude patients because of adverse events, unsatisfactory response or because of protocol violation. Our study included patients with comorbidities and with other clinical characteristics of psoriasis than plaque psoriasis. 37% of patients did not have a pretreatment value of PASI >10. Mean PASI scores at baseline in the studies mentioned above were between 14.5 and 21.4. It should also be acknowledged that the PASI can be affected by observer variation. In RCTs the assessment is made by a few trained physicians, whereas the PASI assessed in a national register of everyday clinical practice is dependent on several assessing physicians.
Despite the limitations of real-world data, results provide important knowledge about how treatment works in real-world practice. About a fourth of patients in this study who switched to a biological agent had pretreatment PASI ≤10 and DLQI ≤10. These patients did not benefit, on average, as much concerning HRQOL from biological agents as patients with severer psoriasis (PASI >10 and/or DLQI >10). This suggests that society could gain health (QALYs) by re-allocating resources from currently treated patients with low gains (low pretreatment PASI and DLQI scores) to untreated patients with potentially high gains (patients with high PASI and DLQI scores). Let us assume that about 25% of the approximately 1,500 patients currently treated with biological agents for psoriasis in Sweden would have PASI ≤10 and DLQI ≤10 with a utility (EQ-5D gain) of approximately 0.02. By re-allocating resources and treating patients with PASI >10 and/or DLQI >10 and potential utility of 0.14, we would gain 45 QALYs (0.25·1,500·0.12 = 45). This naïve estimate assumes that patients with PASI >10 and/or DLQI >10 currently treated with conventional treatments would respond as patients in our study and that utility would be constant over a year. Even though individual patients with low PASI and DLQI values may suffer from their disease, this study shows that, on average, patients with PASI >10 and/or DLQI >10 tend to have the highest benefits, suggesting that this patient group would be most cost-effective to treat.
When new treatments are introduced in clinical practice, it may be challenging to target the unselected patient groups for which these treatments are effective. Future research should investigate potential over- and undertreatment of biological agents in patients with moderate to severe psoriasis in clinical practice.
The authors wish to thank all those who helped to create PsoReg, all patients and all health care personnel and the PsoReg steering board. We wish to thank our reviewers for the beneficial comments on the manuscript.
PsoReg has received financial support from Swedish Board of Health and Welfare, Swedish Association of Local Authorities and Regions, Västerbotten County Council, Abbott, Jansen-Cilag, Leo Pharma, MSD and Pfizer. This research has, in addition, received financial support from Abbott, Jansen-Cilag, Leo Pharma and Pfizer. The sponsors had no access to data. Data collection, study design, interpretation, and analysis have been carried out with authors' independence. None of the authors has a conflict of interest to declare.
Arvelig hudsygdom, der viser sig som tørre, rødlige velafgrænsede plamager med lyse skæl i større eller mindre områder. Specielt findes udslættet ved ydersiden af albuerne, på knæene samt i hovedbunden.
Navnet på denne sygdom stammer fra det græske ord psorao, der betyder udslæt. Psoriasis giver normalt ikke kløe.
- Dårlig fordøjelse - særlig af proteiner. Et tilstand som med tiden kan udvikle en mangfoldighed af helbredsproblemer.
- Overvægt og fedme: Har vist sig at være en stærk risikofaktor hos kvinder
- Vækst af Candidasvampen i tarmen, hvorved der optages en masse svampetoksiner i blodet.
- Nedsat leverafgiftning. Leveren kan overbelastes af forskellige giftstoffer fra tarmen, bl.a. de nævnte svampetoksiner, visse mediciner og af alkohol. Indtagelse af alkohol er kendt for at kunne forværre psoriasis-symptomer.
- Allergi overfor forskellige metaller
- Beskadigelse af huden - også fordi man kradser sig pga. kløe.
- Psykiske ubalancer: Huden er særlig påvirkelig over for emotionelle ubalancer - og herunder for stress.
- Øget risiko for hjerteanfald. Yngre personer med svær psoriasis har en let forøget risiko i forhold til raske for på et tidspunkt at få et hjerteanfald.
Der er flere varianter af psoriasis. Den mest almindelige form kaldes Psoriasis vulgaris. Symptomerne begynder som et udslæt med små røde knopper på huden som efterhånden breder sig. Det angrebne område danner store mængder skæl. Det er de øverste skæl, som er grå-hvide og fedtede, der falder af. De nederste skæl sidder fast. Det er karakteristisk for psoriasis, at hvis man skraber dem af, vil huden bløde lidt.
Generelle kostråd for syge og raske samt råd til sygdomsforebyggende livsstil findes i biblioteket. Klik her
- A-vitamin: Tag 50.000 i.e dgl. i en måned. Herefter tages 10-20.000 i.e. og altid sammen med zink.
- B-vitaminkur: 1000-3000 µg B12 daglig og 50-150 mg B9 (folinsyre) daglig i 2-3 måneder.
- D-vitamin i form af D3
- E-vitamin: 400 i.e. dgl.
- Zink: 30 - 50 mg dgl.
- Sporstoffer: Små doser nikkel og brom i letoptagelig homøopatisk form har vist sig at kunne bedre psoriasis hos mange. Ikke til nikkelallergikere.
- Aloe vera: Tag det indvortes hver dag og kombinér med Aloe vera salve udvortes efter behov.
- Bittersød Natskygge (Solanum dulcamara): Bruges indvortes til behandling af psoriasis og andre hudlidelser.
- Burre, glat (Arctium lappa): Fjerner affaldsstoffer og virker bakteriehæmmende ved eksem, psoriasis og hudinfektioner.
- Gyldensegl (Hydrastis canadensis):
- Kamille (Chamomilla recutita): Både ud- og indvortes. Leverstyrkende og betændelseshæmmende.
- Lakridsrod (Glycyrrhiza glabra): Har nogle kortisonlignende virkninger på psoriasis og kan forstærke effekten af hydrokortison-creme.
- Lavendel (- Lavandula): Udvortes.
- Mahonie (Mahonia aquifolium): Indeholder alkaloider der virker bakteriehæmmende og fordøjelsesfremmende. Har i cremer brugt mod psoriasis vist gode resultater i løbet af 3 måneder.
- Marietidsel (Silybum marianum): Styrker leveren og fremmer fordøjelsen.
- Sarsaparil (Smilax officinalis): Virker blodrensende og er et traditionelt middel mod hudlidelser
- Omega 3 fedtsyrer (fiskeolie - hørfrøolie): Har vist god effekt på psoriasis. Tages med E-vitamin.
- Omega 6 fedtsyrer (Kæmpenatlysolie): Kan gavne på ud- og indvortes.
- Rapsolie: Kan bruges udvortes på udslæt.
- Lecithin: Godt til leveren og cellemembranerne
- Carnitin: Der er gode erfaringer med at tage aminosyren Carnitin mod psoriasis og psoriasisgigt. Det virker sandsynligvis ved at gribe regulerende ind i fedtsyrestofskiftet. Dosering er 2,5 g daglig forskudt for måltider.
- Fordøjelsesenzymer: Hjælper mod en mangelfuld nedbrydning af proteiner, fedtstoffer og kulhydrater.
- Mælkesyrebakterier: Hjælper til at genoprette en dårlig tarmflora.
- Kefir: Et glas Kefirmælk daglig har hjulpet nogle.
- Tjærepræparater: Kan gavne, men brug dem ikke på sår.
- Sol og lysbehandling: Er meget benyttet. Beskyt den ikke-angrebne hud med masser af solcreme.
- Kurrejser til Det døde Hav: Gerne i 4 uger - hjælper mange. Der er masser af sol, og vandet har et højt indhold af salt og mineraler. Man kan også prøve at rekonstruere Det døde Hav hjemme i badekarret ved hjælp af en pose havsalt og nogle sporstoffer.
- Manuelle behandlinger: F.eks. zoneterapi og akupunktur kan være en hjælp.
Det vil ofte være en god idé at rådføre sig med en erfaren behandler der kan sammensætte et individuelt tilpasset program.
- Multivitamin-mineraltilskud: "VitaMax" 2 tbl morgen og aften. Til maden.
- Ekstra Krom: "Chromium GTF 200" 1 kpsl dgl. Til maden.
- Ekstra A-vitamin (i en kort periode ved udbrud, men ikke til gravide): 20.000 i.e.
- Fibertilskud: 5 g vandopløselige fibre om aftenen.
- Carnitin: 2,5 g daglig. Tages med vand 1 time før et måltid.
- Aloe vera creme
- Creme med dødehavssalt
Bittersød Natskygge, Solanum dulcamara er giftig i for store doser. Bør kun bruges indvortes under vejledning af kyndig urtespecialist.
Se også Autoimmune sygdomme her og Hudproblemer her