This study looked at the Danish population and investigated the death rate of it's people with psoriasis and concluded that patients with psoriasis demonstrated a reduced lifespan.

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Background:
Psoriasis is a common chronic disease, mediated by type 1 and 17 helper T cell-driven inflammation. Epidemiological studies have demonstrated a wide range of comorbidities and increased mortality rates. However, the current evidence on psoriasis-related mortality is limited and nationwide data have not been presented previously.

Methods:
In a nationwide population-based cohort we evaluated all-cause and cause-specific death rates in patients with psoriasis as compared to the general population.

Results:
The entire Danish population aged 18 and above, corresponding to a total of 5 458 627 individuals (50.7% female, 40.9 years ± 19.7), including 94 069 with mild psoriasis (53% female, 42.0 ± 17.0 years) and 28 253 with severe psoriasis (53.4% female, 43.0 ± 16.5 years), was included. A total of 884 661 deaths were recorded, including 10 916 in patients with mild psoriasis and 3699 in patients with severe psoriasis. The age at time of death varied by psoriasis status, i.e. 76.5 ± 14.0, 74.4 ± 12.8 and 72.0 ± 13.4 years, for the general population, mild psoriasis and severe psoriasis respectively. In general, the highest death rates were observed in patients with severe psoriasis. Overall death rates per 1000 patient years were 13.8 [confidence interval (CI) 13.8–13.8], 17.0 (CI 16.7–17.3) and 25.4 (CI 24.6–26.3) for the general population, patients with mild psoriasis and patients with severe psoriasis respectively.

Conclusion:
This nationwide population-based study of cause-specific death rates in patients with psoriasis demonstrated reduced lifespan and increased rates of all examined specific causes of death in patients with psoriasis compared to the general population.

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Histone modifications are associated with Delta(9)-tetrahydrocannabinol-mediated alterations in antigen-specific T cell responses
Authors
Background: Marijuana has been shown to have an immunomodulatory activity.
Results: ChIP-seq results show genome-wide changes in histone methylation in immune cells treated with THC.
Conclusion: Histone modifications are associated with THC-mediated alterations in antigen-specific T cell response.
Significance: This study provides insights into the potential role of epigenetic changes induced by THC in gene regulation.
Abstract

Marijuana is one of the most abused drugs due to its psychotropic effects. Interestingly, it is also used for medicinal purposes. The main psychotropic component in marijuana, Δ9-tetrahydrocannabinol (THC), has also been shown to mediate potent anti-inflammatory properties. Whether the immunomodulatory activity of THC is mediated by epigenetic regulation has not been investigated previously. In this study, we employed ChIP-Seq technology to examine the in vivo effect of THC on global histone methylation in lymph node cells of mice immunized with a superantigen, staphylococcal enterotoxin B (SEB). We compared genome-wide histone H3K4, H3K27, H3K9, H3K36 trimethylation and H3K9 acetylation patterns in such cells exposed to THC or vehicle. Our results showed that THC treatment leads to the association of active histone modification signals to Th2 cytokine genes and suppressive modification signals to Th1 cytokine genes, indicating that such a mechanism may play a critical role in THC-mediated switch from Th1 to Th2. At the global level, a significant portion of histone methylation and acetylation regions were altered by THC. However, the overall distribution of these histone methylation signals among the genomic features were not altered significantly by THC, suggesting that THC activates the expression of a subset of genes while suppressing the expression of another subset of genes through histone modification. Functional classification of these histone marker associated genes showed that these differentially associated genes were involved in various cellular functions, from cell cycle regulation to metabolism, suggesting that THC had a pleiotropic effect on gene expression in immune cells. Together, the current study demonstrates for the first time that THC may modulate immune response through epigenetic regulation involving histone modifications.

This is an interesting study that looked at the effects of psoriasis on a cohabitant. We as psoriasis patients are checked for our Dermatology Life Quality Index (DLQI) but we never think of those around us who have to put up with us.

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Background:
Numerous studies have analyzed the influence of psoriasis on the quality of life and psychosocial health of patients. However, few studies have addressed the effect of this disease on individuals living with these patients (cohabitants).

Objective:
To analyze the influence of psoriasis on the levels of anxiety, depression, and quality of life of the cohabitants of psoriatic patients.

Methods:
The study included patients, cohabitants, and controls, a total of 130 participants. Their quality of life was measured with the Dermatology Life Quality Index (DLQI) and Family Dermatology Life Quality Index (FDLQI), and their psychological state with the Hospital Anxiety and Depression Scale (HADS). Demographic data of participants and clinical characteristics of patients were also gathered.

Results:
The presence of psoriasis impaired the quality of life of 87.8% of the cohabitants. FDLQI scores of cohabitants were significantly associated with the DLQI scores of the patients (rs = 0.554; P < .001). Anxiety and depression levels did not differ between patients and cohabitants, but were significantly higher than in the controls (P < .001).

Limitations:
Additional studies with larger numbers of patients and cohabitants are required to analyze differences between groups according to psoriasis severity.

Conclusion:
Psoriasis markedly worsens the global well-being of patients and their cohabitants, who experienced an impairment of their quality of life and higher levels of anxiety and depression.

Just wondering how people deal with the redness and soreness with psoriasis in the buttcrack. Do you use moisturizers or ointments or steroid creams? Having a terrible time down there.

Strides Arcolab an Indian pharmaceutical company headquartered at Bangalore in southern India has been given FDA approval for Methoxsalen

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Strides Arcolab today announced that it has received approval from the United States Food & Drug Administration (USFDA) for Methoxsalen Capsules USP, 10 mg (Soft Gelatin Capsules).

According to IMS data, the US market for generic Methoxsalen Capsule is approximately USD 13.6 Million, with no generic player.

The product will be manufactured at the Company’s USFDA approved Oral dosage facility at Bangalore and marketed directly by Strides in the US Market.

About Methoxsalen Capsules:
Methoxsalen is a drug used to treat psoriasis, eczema, vitiligo and some cutaneous lymphomas in conjunction with exposing the skin to UVA light from lamps or sunlight.

Methoxsalen modifies the way skin cells receive the UVA radiation, clearing up the disease.

This study suggests activation of the Aryl Hydrocarbon Receptor dampens the severity of psoriasis.

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Environmental stimuli are known to contribute to psoriasis pathogenesis and that of other autoimmune diseases, but the mechanisms are largely unknown. Here we show that the aryl hydrocarbon receptor (AhR), a transcription factor that senses environmental stimuli, modulates pathology in psoriasis.

AhR-activating ligands reduced inflammation in the lesional skin of psoriasis patients, whereas AhR antagonists increased inflammation. Similarly, AhR signaling via the endogenous ligand FICZ reduced the inflammatory response in the imiquimod-induced model of skin inflammation and AhR-deficient mice exhibited a substantial exacerbation of the disease, compared to AhR-sufficient controls.

Nonhematopoietic cells, in particular keratinocytes, were responsible for this hyperinflammatory response, which involved upregulation of AP-1 family members of transcription factors.

Thus, our data suggest a critical role for AhR in the regulation of inflammatory responses and open the possibility for novel therapeutic strategies in chronic inflammatory disorders.

Hi all,
I am a soap maker by trade. I have been making soap for 22 years and counting.
I have recently been diagnosed with plaque P. I am going to be formulating a recipe for pine tar soap and am trying to decide on using hot process or cold process. Also I may try making an ointment as well. The dr has me using steroid cream right now. I would like to stay away from the steroids if at all possible. Are there any other Soapers here to bat this around with?
Thanks, Pam.

I'm a 48 year old woman. I never had psoriasis in my past. My story starts out last July when I developed a sore on my lower shin that wouldn't go away. It kept peeling and the size slowly increased. It didn't even occur to me then that it was psoriasis. I had previously had rare occurences of eczema, but this didn't feel the same. I had always had ichthyosis vulgaris, with keratosis bumps and the celophane looking legs.

The sore got bigger and then another sore developed on my other leg just below the knee, then it spread to my scalp. This occurred over 3-4 months. I had been on a fairly restrictive diet trying to lose weight, and then around Halloween and into the holidays I fell off the wagon and went back to eating basically anything. The sores multiplied. By the first week of December I had approximately 14 sores over my body, mostly on my upper legs and a few around my elbows. These were very swollen and red and peeled almost daily. By Christmas they had spread to the backs of my arms, I had a couple of small sores on my face, many more sores in my scalp and ears, and across the tops of my buttocks. I was horrified. I started looking at images on google and determined that this was psoriasis.

I picked up OTC psoriasis creams. Nothing was helping. The end of January my mother told me there was a research study she had heard about for psoriasis. I told her I was looking for an holistic approach. I heard the commercial twice. The second time I thought, "Well, I'll just call. Maybe they can confirm that it's psoriasis and maybe I won't qualify." So I called and talked to the research assistant. She said that I needed to have had it for 6 months, that it needed to be predominantly plaque psoriasis and that it needed to cover 10% of my body. She explained that the palm of your hand represents about 1%. Did I have 10 of those? I didn't think I did. I thought maybe 5. She said I should come in anyway and they would take a look and determine if I would qualify. So, I went in that day. It was psoriasis, plaque psoriasis. And I had it on 8% of my body, so I didn't qualify. But, they had another program---something about laser treatments. Did I want to talk to the lady in that department? Sure, I'd talk to her. So Paula came and I followed her to her office. In talking to her, I felt that this wasn't the answer either. The psoriasis was spreading so quickly that I felt that doing lasers in one spot wouldn't stop it from spreading in another spot so I told her I'd keep looking for an holistic approach. She got up and closed the door and asked me if I'd ever heard of NAET. NAET? What is NAET? It's "Nambudripad's Allergy Elimination Technique". I was intrigued. Until that point, I had never really considered my skin issues allergy related.

I started researching NAET. This protocol basically reprograms your brain/body to not react to an allergen, to look at it as a friend rather than a foe. I found a practitioner with 18 years of experience and a couple weeks later did the testing to determine what allergies I had. I had quite a few. They treat one allergen each time. Because of the many allergies, I started going 3 times per week. The psoriasis continued to spread for a time and ultimately I probably had the psoriasis over 40% of my body, but I was seeing improvement in some of the sores. Some seemed to be clearing from the inside, giving a small circle of clear skin with psoriasis bumps around the outside, but none were going away completely. The overall swelling was improving as well and the peeling was lessening, but still the sores remained. But finally, the spreading had stopped. I wasn't getting new sores. I then read something about the benefits of turmeric and how it helps with psoriasis as it's a natural anti-inflammatory. I decided to add turmeric into my routine--1000mg 2x/day. The changes were very quick at this point. The rest of the inflamation went away, the redness started to fade. I began to think that maybe the turmeric itself was the trick, but when I had a reaction to dogs a couple weeks later, I knew that it was the combination because the turmeric didn't stop the reaction, but it helped me to get past it after the flare up.

I have now been through 32 treatments, and have maybe 3 more to do. My psoriasis is healing wonderfully. Most is completely gone. I have no red swollen areas, but just a few little hard bumps that are slowly receding. They don't even peel. They account for about 1/4 palm's worth. In addition, I can eat anything I want, I can be around dogs, and I feel really good. I'm even wearing short sleeves and short pants again.

Did you know...
If you click on portal ( third item along under the green banner) which I think this is a most useful facility
A ) you can see the last ten posts
B) if you scroll down on the right hand side you can see links to polls, and other quick links
C) you can see at a glance if their are messages for you
D) at the bottom are the forum statistics if you click on full statistics you can see which are the most read posts how many hits they have had etc.
And for members that may have trouble navigating around the site there are links to these threads
E) in the main body you can read the latest threads

I just thought that the Portal was an under used facility and may help some members navigating the forum

A study published in The Journal of the American Academy of Dermatology looked at The impact of palmoplantar psoriasis on health-related quality of life (QoL) and concluded Patients with palmoplantar psoriasis experience greater health-related QoL impairment and are more likely to report heavy use of topical prescriptions than those with moderate to severe plaque psoriasis.

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Background:
The impact of palmoplantar psoriasis on health-related quality of life (QoL) is largely unknown.

Objective:
We sought to compare clinical characteristics and patient-reported outcomes between patients with palmoplantar psoriasis and moderate to severe plaque psoriasis.

Methods:
We conducted a cross-sectional study of patients with plaque psoriasis (N = 1153) and palmoplantar psoriasis (N = 66) currently receiving systemic or light treatment for psoriasis.

Results:
Patients with palmoplantar psoriasis were more likely to report Dermatology Life Quality Index scores that correspond to at least a moderate impact on QoL (odds ratio [OR] 2.08; 95% confidence interval [CI] 1.20-3.61); problems with mobility (OR 1.98; 95% CI 1.10-3.58), self-care (OR 3.12; 95% CI 1.24-7.86), and usual activities (OR 2.47; 95% CI 1.44-4.22) on the European Quality of Life-5 Dimensions questionnaire; and heavy topical prescription use of at least twice daily in the preceding week (OR 2.81; 95% CI 1.63-4.85) than those with plaque psoriasis.

Limitations:
Our assessment tools may not account for all dimensions of health-related QoL affected by palmoplantar disease, and these results may not be generalizable to patients with milder forms of psoriasis.

Conclusion:
Patients with palmoplantar psoriasis experience greater health-related QoL impairment and are more likely to report heavy use of topical prescriptions than those with moderate to severe plaque psoriasis.

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What are your thoughts guys? I know this is a little out there

This study set out to identify pathways and mechanisms affected by Fumaric acid esters (FAE) treatment and to compare them with pathways affected by treatment with the anti-TNF-α biologic Enbrel (etanercept)

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Background:
Fumaric acid esters (FAE) are widely used in Europe for the treatment of psoriasis because of their clinical efficacy and favourable safety profile. However, the mechanisms of action by which FAE improve psoriasis remain largely unknown.

Objectives:
To identify pathways and mechanisms affected by FAE treatment and to compare these with pathways affected by treatment with the anti-TNF-α biologic etanercept.

Methods:
In a prospective cohort study, 50 patients with plaque psoriasis were treated with FAE for 20 weeks. Nine patients were randomly selected for gene expression profiling of plaque biopsies from week 0 and week 12. The groups consisted of FAE responders (>PASI-75 improvement) and non-responders (<PASI-50 improvement). Changes in gene expression profiles were analyzed using Ingenuity Pathway Analysis (IPA) and the outcome was compared with gene expression affected by etanercept.

Results:
Response to FAE treatment was associated with a ≥2-fold change (P<0.05) in the expression of 458 genes. In FAE responders the ‘role of IL17A in psoriasis’ pathway was most significantly activated. Glutathione and Nrf2 pathway molecules were specifically induced by FAE treatment and not by etanercept treatment, representing a FAE specific effect in psoriatic skin. In addition, FAE treatment specifically induced the transcription factors PTTG1, NR3C1, GATA3 and NFκBIZ in responding patients.

Conclusions:
FAE treatment induces glutathione and Nrf2 pathway genes in lesional skin of patients with psoriasis. In responders FAE specifically regulates the transcription factors PTTG1, NR3C1, GATA3 and NFκBIZ, which are important in normal cutaneous development, Th2 and Th17 pathways, respectively.

This Danish nationwide cohort study looked at the Risk of thromboembolism and fatal stroke in patients with psoriasis

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Objectives:
Psoriasis is a chronic inflammatory disease that is associated with a prothrombotic state and cardiovascular disease, including atrial fibrillation and thromboembolism. We therefore evaluated the impact of psoriasis in patients with atrial fibrillation and the performance of the CHA2DS2VASc score in these patients.

Design, setting, and participants:
The study comprised all Danish patients hospitalized with non-valvular atrial fibrillation in the period 1997-2011 (n=99,357). Follow-up started 7 days from discharge and excluded subjects treated with anticoagulation. Poisson regression adjusted for CHA2DS2VASc score were used to estimate the incidence rate ratios and 95% confidence intervals.

Main outcome measure:
Hospitalization or death from thromboembolism.

Results:
Mean follow-up was 3.5, 3.1, and 2.8 years for patients with no psoriasis, mild psoriasis, and severe psoriasis, respectively. Patients with psoriasis were younger compared to patients without psoriasis, but CHA2DS2VASc score did not differ between the 3 groups. Thromboembolism rates per 100 patient years (95% confidence intervals) were 4.8 (4.7-4.9), 4.8 (4.2-5.4), and 6.1 (5.0-7.5) for patients with no psoriasis, mild psoriasis, and severe psoriasis, respectively. Importantly, the observed thromboembolism rates in patients with severe psoriasis were markedly higher (2.6–3.4 fold) than predicted by the CHA2DS2VASc score. Relative to no psoriasis, incidence rate ratios were 0.99 (0.87-1.11) and 1.27 (1.02-1.57) for mild and severe psoriasis, respectively. Correspondingly, incidence rate ratios for fatal stroke were 0.97 (0.80-1.12) and 1.51 (1.12-2.05).

Conclusions:
In patients with non-valvular atrial fibrillation not treated with oral anticoagulation severe psoriasis was associated with increased risk of thromboembolism. In these patients CHA2DS2VASc underestimated the risk of thromboembolism.

This study looked at latent tuberculosis infection in psoriasis patients using biological therapy, and compares them with patients with crohn's disease, rheumatoid arthritis, and healthcare workers.

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Background:
Screening for latent tuberculosis infection (LTBI) is mandatory in patients with psoriasis prior to biological therapy.

Objective:
Investigate the prevalence of LTBI in patients with psoriasis candidate to biological therapy.

Methods:
LTBI was investigated in patients with moderate-to-severe psoriasis (n=243), Crohn's disease (n=64) or rheumatoid arthritis (n=56) (RA) and in healthcare workers (n=1683). LTBI diagnosis was based on positive QuantiFERON-TB-Gold in tube (QFT) in vitro assay without any clinical, radiological or microbiological evidence of active tuberculosis.

Results:
LTBI was diagnosed in 8.2% of patients with psoriasis, 6.5% with Crohn's disease, 8.9% with RA and in 8.8% healthcare workers (p=0.9). Psoriatic patients with LTBI (n=20) received a 9-months prophylaxis with isoniazid (5 mg/kg/day) and no one developed active tuberculosis infection after receiving biological therapy (etanercept, adalimumab, infliximab or ustekinumab) for 37 ± 32 weeks (mean ± SD). All psoriatic patients were re-tested for LTBI after 31 ± 1.7 months. Five patients out of 20 with LTBI presented QFT reversion and 2 patients out of 243 (0.8%) had QFT conversion and received antibiotic prophylaxis.

Conclusions:
Prevalence of LTBI in patients with psoriasis is similar to patients with Crohn's disease, RA and healthcare workers. Prophylaxis with isoniazid is effective in preventing tuberculosis reactivation in patients with LTBI receiving biological therapy.

This study was published in The British Journal of Dermatology and looks at the pattern of response in patients with moderate-to-severe psoriasis treated with Enbrel (etanercept)

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Background:
Etanercept (ETN) 50 mg once-weekly (QW) or 50 mg twice-weekly (BIW) for 12 weeks, followed by 50 mg QW in all subjects through week 24 improved psoriasis in patients with concomitant psoriatic arthritis in the PRESTA trial. Data from PRESTA were used to evaluate the effect of ETN in the treatment of psoriasis by Psoriasis Area Severity Index (PASI) body-region and component, and determine if PASI responses correlate with the Dermatology Life Quality Index (DLQI).

Methods:
Median time to 75% improvement in PASI (PASI75), body-specific and component-specific subscales over 24 weeks was estimated. Pearson correlation coefficients determined the association between DLQI score and PASI total score, body- and component-specific subscales with ETN treatment at baseline and up to Week 24.

Results:
748 patients from PRESTA were included (ETN 50 mg QW/QW, n = 371; BIW/QW, n = 377). Patients achieved PASI75 total score and 75% improvements in all body regions and components faster on ETN 50 mg BIW/QW than QW/QW (all P <0.05). Median time to 75% improvement was faster for the head and trunk followed by upper and lower extremities, and for induration and desquamation followed by erythema and total area. Weak to moderately positive correlations between improvements in DLQI and PASI total score (range, r=0.223–0.463), all PASI body-specific (r=0.114–0.432) and component-specific (r=0.178–0.478) subscales were observed over 24 weeks.

Conclusions:
Etanercept treatment-response appears to occur in a body- and component-specific manner. Changes in quality of life are not captured by either PASI or its subscales.

This study suggests the use of ultrasonography to the Achilles’ tendon in early diagnosis of psoriatic arthropathy with the aim of preventing the progression of the pathology could be beneficial.

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Background:
Psoriatic Arthropathy is a progressive and debilitating disease which involves a reduction of the functional activity of the articulations with consequent deterioration of the patient's quality of life. The entheses represent the initial site of articular inflammation and the enthesis of the Achilles’ tendon is the first to be affected. In some patients with psoriasis, enthesitis may not be diagnosed because it is still asymptomatic.

Objective:
To evaluate whether ultrasonography may allow early diagnosis in a larger population and identify significant alterations of enthesitis beyond increased of thickness of the Achilles tendon.

Materials and Methods:
The study was undertaken on 59 patients (16 women, 43 men), affected by chronic plaque psoriasis and 59 patients suffering from other dermopathies. The patients underwent echographic evaluation, adopting Voluson, utilizing 12-MHz linear transducer on the Achilles’ heel. The severity of the psoriasis was evaluated by PASI, the enthesitis by the Glasgow Ultrasound Enthesitis Scoring System (GUESS).

Results:
The GUESS score resulted higher in those patients with psoriasis compared to patients suffering from other dermopathies. 22.03% of psoriatic patients (13 out of 59) presented over 5.29 mm tendon thickness and irregular tendon structure. In 12 patients there were also other abnormalities affecting the tendon. In seven patients (11.9%) bursitis was also revealed.

Conclusions:
Our data confirm that ultrasonography is a sensitive technique which reveals enthesitis more frequently than clinical examination in patients affected by psoriasis. We, therefore, suggest the use of ultrasonography to the Achilles’ tendon in early diagnosis of psoriatic Arthropathy with the aim of preventing the progression of the pathology.

This study published in The British Journal of Dermatology looks at treatment goals that have been developed to optimize daily clinical practice psoriasis care for patients using biologics.

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Background:
Treatment goals have been developed to optimize daily clinical practice psoriasis care, but have not yet been studied in real life.

Objectives:
To investigate to what extent treatment decisions made by dermatologists for psoriasis patients on biologics in daily clinical practice are already in accordance with the treatment goals without the active application of the treatment goals algorithm.

Methods:
Data were extracted from a prospective daily practice cohort of psoriasis patients on biologics. Analysis was done on effectiveness (Psoriasis Area and Severity Index score) and quality of life (Dermatology Life Quality Index questionnaire). Treatment decisions such as dosage adjustments, combination treatments, or switching therapy were compared to the treatment goals algorithm.

Results:
In 64% (253 of 395) of visits, physicians followed treatment goals algorithm. There were 162 (41%) visits in which there should have been a treatment modification according to treatment goals (group Modify) and a modification was indeed made in 59 of these 162 visits (36%). In 233 (59%) visits no treatment modification was necessary (group Continue) and therapy was indeed not modified in 194 of 233 visits (83%).

Conclusions:
Physicians acted in accordance with treatment goals in the majority of patient visits. In the patient group not achieving these goals, physicians should have modified therapy according to treatment goals but continued the same therapeutic regimen in the majority of visits. Optimizing therapy and defining barriers in the latter group might increase treatment results in daily practice psoriasis care.

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Pfizer Inc. announced today detailed results from the Oral treatment Psoriasis Trial (OPT) Retreatment study (A3921111), a Phase 3 study investigating tofacitinib for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. This three-period study showed that tofacitinib, as a 5 mg or 10 mg pill taken twice daily, met its two primary efficacy endpoints. The safety profile of tofacitinib in OPT Retreatment was consistent with previous studies and there were no new safety findings in this trial.

The first primary endpoint of OPT Retreatment evaluated the maintenance of clinical response in patients who remained on tofacitinib after an initial treatment phase compared to patients who were switched to placebo (withdrawal phase). The second primary endpoint examined patients who lost half of their original clinical response during the withdrawal phase, and measured the proportion of these patients who regained their original clinical response after restarting treatment with tofacitinib. Throughout the study, the efficacy response was measured by the proportion of subjects achieving a Physician’s Global Assessment (PGA) response of “clear” or “almost clear” skin and the proportion of subjects achieving at least a 75% reduction in the Psoriasis Area and Severity Index (PASI75), two commonly used measures of efficacy in psoriasis.

“Psoriasis is a chronic disease that affects approximately two-to-three percent of people worldwide, and there are times when patients with psoriasis may need to stop and restart therapy for medical or non-medical reasons, such as elective surgery or receipt of live immunizations,” said lead investigator Robert Bissonnette, M.D., Innovaderm Research, Montreal, QC, Canada. “The OPT Retreatment data showed that patients who stayed on therapy with tofacitinib maintained their rates of response and for those who stopped therapy, a proportion of patients were able to regain their original clinical response when retreated with tofacitinib.”

Tofacitinib, an oral Janus kinase (JAK) inhibitor, is part of a new class of medicines in development for the treatment of moderate-to-severe plaque psoriasis. Top-line results from OPT Retreatment were previously announced in October 2013, and the detailed results of this study were shown today in an oral presentation during the 11th European Academy of Dermatology and Venereology (EADV) Spring Symposium in Belgrade, Serbia.

OPT Retreatment was a Phase 3 randomized, double-blind, three-period, parallel group, placebo-controlled 56-week study. This study evaluated the efficacy and safety of the withdrawal and retreatment with tofacitinib 5 mg and 10 mg twice daily compared to placebo in 674 adult patients with moderate-to-severe chronic plaque psoriasis. During the first period (24 weeks), which was a secondary endpoint of this study, patients were treated with either tofacitinib at a dose of 5 mg or 10 mg twice daily in a blinded manner. During this initial 24 weeks of treatment: 44% and 68% of patients who received tofacitinib 5 mg and 10 mg twice daily achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI75), respectively, and 42% and 63% of patients who received tofacitinib 5 mg and 10 mg twice daily achieved a PGA response of “clear” or “almost clear” skin, respectively.

The patients who achieved a PASI75 and PGA response were then randomized to either continue tofacitinib or switch to placebo for 16 weeks or until they lost half of their original PASI response to treatment, whichever occurred first. During this withdrawal period: A statistically significantly greater proportion of patients who remained on both doses of tofacitinib maintained PASI75 and PGA responses relative to patients who were switched to placebo, and no patients experienced psoriasis rebound (rapidly spreading psoriasis after treatment withdrawal).

In the retreatment period, all patients resumed their original tofacitinib dose until week 56. After 16 weeks of restarting therapy with tofacitinib, the efficacy response was evaluated in the proportion of patients who lost half of their original PASI or PGA response during the withdrawal phase and showed that: 36.8% and 61.0% of patients who received tofacitinib 5 mg and 10 mg twice daily, respectively, achieved a PASI75; and 44.8% and 57.1% of patients who received tofacitinib 5 mg and 10 mg twice daily, respectively, achieved a PGA of “clear” or “almost clear” skin.

The most common adverse events for all study periods were nasopharyngitis and upper respiratory tract infection. There was one cardiac-related death that occurred during the OPT Retreatment study at the 5 mg dose. However, in the opinion of the investigator, there was not a reasonable possibility that this death was related to tofacitinib.

OPT Retreatment is one of five studies from the Phase 3 OPT Clinical Trial Program, one of the largest global clinical trial programs in moderate-to-severe chronic plaque psoriasis to date. The results from this study will be included in the planned tofacitinib psoriasis submission package to regulatory authorities in various markets. Pfizer currently intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of tofacitinib for the treatment of adults with moderate-to-severe chronic plaque psoriasis by early 2015.

Is it common to have liver damage from the use medication?