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Posts for tag: Psoriasis

Novel Psoriasis Treatment Demonstrates Safety and Efficacy

Author: Julia Ernst, MS



Ponesimod, a selective modulator of the sphingosine 1-phosphate (S1P) receptor 1 S1PR1), has been shown to be efficacious for improving both disease and quality of life markers in patients with moderate to severe chronic plaque psoriasis, according to a study published recently in The Lancet.
S1PR1 exists on the surface of T lymphocytes and controls “the egress of these cells from lymph nodes into blood,” explained Daniele D'Ambrosio, MD, PhD, Senior Director and Clinical Program Head of Autoimmunity in Clinical Science for Actelion Pharmaceuticals Ltd. in Switzerland. “There is evidence indicating that pathogenic T cells become activated in the lymph nodes and subsequently migrate through blood into the skin of patients with psoriasis to cause the formation of psoriatic plaques. By functionally blocking S1PR1, ponesimod may prevent the recruitment of pathogenic cells into the skin of patients with psoriasis, leading to resolution of the plaques.”
The phase 2, double-blind, randomized, placebo-controlled, parallel-group, multicenter study conducted by D’Ambrosio and colleagues randomized eligible patients in two periods. The first randomization period (the induction period) grouped patients in a ratio of 1:2:2 to receive oral placebo, 20 mg ponesimod, or 40 mg ponesimod. Patients who had achieved at least a 50% reduction in Psoriasis Area and Severity Index (PASI) scores from baseline by Week 16 were eligible to enter the maintenance period (Weeks 16–28). Patients in the placebo group continued to receive placebo during this time. Patients in the ponesimod 20 mg and 40 mg groups were re-randomized in blocks of four to receive ponesimod at the same dose as in the induction period or placebo, in a 1:1 ratio, according to the article on the study in The Lancet.
The primary efficacy endpoint was a 75% reduction in PASI scores from baseline, with a secondary endpoint of a score of 0 or 1 on the Physician’s Global Assessment (PGA) at Week 16, according to the article in The Lancet. Quality of life was assessed using the Dermatology Life Quality Index (DLQI). The researchers also recorded adverse events (AEs), including serious AEs.
The greatest improvements were seen among patients in the 40 mg ponesimod group, according to the results in The Lancet. At Week 16, PASI 75 was achieved by 64 patients (48.1%) in the 40 mg group, compared to 58 (46%) patients in the 20 mg group and nine (13.4%) patients receiving placebo. A higher proportion of subjects receiving the 40 mg dose of ponesimod (33 patients, or 24.8%) achieved PASI 90 by Week 16 compared to 18 (14.3%) patients in the 20 mg group and two patients (3%) on placebo. By the same time period of Week 16, PGA scores of zero or one were seen in 43 patients in the 40 mg ponesimod group (32.2%), 35 patients (27.8%) in the 20 mg group, and three (4.5%) in the placebo group. Mean change from baseline in DLQI scores, compared to placebo, were -3.4 (95% confidence interval [CI] -5.2 to -1.6) for the 20 mg ponesimod group and -3.7 (-5.6 to -1.9) for the 40 mg ponesimod group.
“Our study showed that ponesimod treatment was able to reduce skin manifestations in patients with moderate to severe psoriasis and improve patient's perception about their disease and quality of life,” D’Ambrosio explained. “The magnitude of the benefits observed with ponesimod appeared to be in the range of those seen with Enbrel, one of the most commonly prescribed injectable drugs, and compared favorably to oral therapies that are currently available or in late stage of development for psoriasis. Additionally, ponesimod seemed to improve the joint pain associated with psoriatic arthritis in the subgroup of patients in our study who had this condition. Ponesimod showed a good tolerability and a promising safety with no indications of cumulative organ toxicities or long-term risk of serious infections or malignancies, in a selected population of psoriasis patients.”
The study found that the 20 mg dose of ponesimod was significantly less effective in patients with a Body Mass Index (BMI) of 30 kg/m2 or higher than in patients with lower BMI. Obesity is a common comorbidity of psoriasis, and, according to D’Ambrosio, “A vast scientific literature suggests that obese people with psoriasis have a lower response to available therapies and higher doses of medications may be necessary for these people.” Like the existing literature, the present study found that obese psoriasis patients seemed to respond less well to ponesimod than non-obese participants.
“Whether a higher dose of ponesimod may be needed in obese patients will need to be further investigated,” Dr. D’Ambrosio notes.
According to the study results in The Lancet, most AEs were mild or moderate. Dyspnea was the most common AE seen in the group receiving a 40 mg dose of ponesimod (35 patients, or 26.3%), while an increase in alanine aminotransferase concentration was most frequent in the group receiving a 20 mg dose (18 patients, or 14.3%). Two cases of malignant disease were reported, both in the 40 mg group: one patient with basal cell carcinoma and one patient with Hodgkin’s lymphoma.
“Ponesimod is an oral, once daily, treatment that has the potential to provide a range of beneficial effects to psoriasis patients that appear comparable to those of seen with injectable therapies,” D’Ambrosio said. “The good tolerability and safety profile observed in our study suggests that ponesimod may fulfill the need for a convenient, well tolerated, and safe treatment for a defined group of patients with psoriasis.” 


October 08, 2014
Category: Drugs
Tags: Psoriasis

Novel Monoclonal Antibody Shows Promising Results for Treating Plaque Psoriasis

Author: Julia Ernst, MS



A new drug with the potential to join the existing class of monoclonal antibodies (mAbs) for plaque psoriasis has shown promising results in a Phase II study.
According to study results published in the Journal of the American Academy of Dermatology (JAAD), itolizumab is a humanized mAb to CD6, a T cell co-stimulator that “may play a role in cell proliferation, adhesion, differentiation, and survival processes,” one of the study’s authors notes. “The CD6 co-stimulatory pathway contributes to the Th1 activation and differentiation of human T cells, promoting a preferentially pro-inflammatory response.” The role of T cells in the pathogenesis of psoriasis has been described with increasingly frequency in medical literature.
For the study, a group of researchers from India and Cuba randomized patients 2:2:1 to three study arms. In Arm A (Weeks 0 to 12), patients received itolizumab at a dose of 0.4 mg/kg/wk for four weeks, followed by a dose of 1.6 mg/kg every two weeks (the induction regimen). In Arm B, patients were treated with itolizumab 1.6 mg/kg every two weeks. Patients in Arm C were the placebo group. During Weeks 12 to 28, Arms A and B received 1.6 mg/kg itolizumab every four weeks until Week 24. The placebo group (Arm C) received a dose of itolizumab 1.6 mg/kg every two weeks until Week 24. From Weeks 28 to 52, depending on Psoriasis Area Severity Index (PASI) score, arms A and B were re-randomized to itolizumab or placebo, switched to open-label itolizumab, or withdrawn, if PASI score was less than 50. Arm C progressed to maintenance itolizumab therapy.
Study outcomes included improvement in clinical markers, indicated by at least a 75% increase in PASI (PASI75) and Physician Global Assessment (PGA) scores, and quality of life via assessment with the Dermatology Life Quality Index (DLQI). Median time to achieve PASI75 was 18 weeks in Arm B, 20 weeks in Arm A, and 24 weeks in Arm C. At Week 12, according to the study results in JAAD, mean change from baseline PGA was “significantly greater than placebo (A vs C, P<.0001; B vs C, P=.0002.” DLQI scores improved across all study arms.
“The PASI50 response at week 28 was in line with most of the other biologics available – around 80%,” explains one study author. “PASI75 was lower, at around 45%-46%. However, a majority of the partial responders turned PASI75 responders after 28 weeks with continued dosing. The most exciting part of the study was [that] response was sustained for a very long time, even after stopping therapy in the randomized withdrawal phase. Median time to loss of PASI75 was around 28 weeks after stopping therapy.”
All biologic agents currently on the market for psoriasis “have to be given in maintenance dose even after complete response to avoid relapse – as frequent as every 14 days,” the author continues, adding that, if the time to relapse observed in this study holds, “We are looking at a biologic treatment which can have least frequent maintenance therapy if at all required.” The author also notes further studies are needed to confirm this finding.
The incidence of adverse events (AEs) over 52 weeks of treatment were similar across Arms A, B, and C (50%, 47.8%, and 53.5% overall, respectively). According to the study results in JAAD, over the length of the trial, there were an incidence of 352, 324, and 365 AEs per 100 person-years respectively for Arms A, B, and C. Common AEs included infusion-related reactions and pyrexia. Five serious AEs were reported in four patients in Arms A or B: exfoliative dermatitis, erythrodermic psoriasis, infusion-related reaction, adjustment disorder with anxiety, and bacterial arthritis. Seven AEs led to withdrawal from the study: lymph node tuberculosis, erythrodermic psoriasis, acute infusion-related reaction, delayed infusion-related reaction, exacerbation of psoriasis, neutropenia, and depressed mood.
In total, 35 patients were anti-drug antibody positive after treatment with itolizumab, although 20 were ADA-positive prior to the start of the study. The authors note that ADA positivity was not correlated clinically to loss of efficacy, as measured by PASI, or safety, such as infusion or injection-site reactions.
“Itolizumab is a safe biologic with a very low infection rate observed (as expected by the upstream mechanism of action) and a long median time to relapse,” one study author notes.
The JAAD study concludes: “Itolizumab has comparable efficacy to existing therapies, has excellent safety, and produces measurable improvements in quality of life.”

By J Michael Maloney MD
October 08, 2014
Category: Scientific Studies
Tags: Psoriasis   treatment   arthritis  

Study Shows that numerous treatments are used in an attempt to control psoriatic arthritis



Patients with Psoriatic Arthritis Tend to Quickly Modify or Abandon Initial Treatment

Author: HCPLive staff



The majority of patients with psoriatic arthritis treated with disease-modifying antirheumatic drugs (DMARDs) will switch medications, discontinue treatment, or add an additional medicine, usually within a few months of initiating treatment.
To gain a better understanding of how often patients alter their therapy, the authors of “Treatment Patterns in Psoriatic Arthritis Patients Newly Initiated on Oral Nonbiologic or Biologic Disease-Modifying Antirheumatic Drugs,” published in Arthritis Research & Therapy, the authors conducted a retrospective study of treatment patterns using data from the US-based Truven Health Analytics MarketScan Research Database for adult patients with psoriatic arthritis who initiated treatment with oral nonbiologic DMARDs or biologic DMARDs. All participants had continuous insurance coverage for at least six months prior to starting treatment, and for at least 12 months after their first prescription fill date.
For the study, 1,698 patients initiated treatment with an oral nonbiologic DMARD and 3,263 patients were initiated on a biologic DMARD. The majority of patients initiating with a nonbiologic DMARD were prescribed methotrexate (71%, n = 1,217).
Other oral nonbiologic DMARDs used included cyclosporine, leflunomide, mycophenolate, gold compounds, antimalarials, minocycline, penicillamine, azathioprine, and sulfasalazine.
Biologic DMARDs in the study included etanercept, infliximab, golimumab, certolizumab pegol, adalimumab, anakinra, abatacept, and rituximab.
When analyzing treatment events and patterns, the authors defined therapy change as “the discontinuation of the index treatment (that is, the nonbiologic or biologic DMARD initiated at the index date), a switch from the index treatment to another treatment, or a therapy add-on.”
Treatment discontinuation was defined as “the first occurrence of a treatment interruption of at least 60 consecutive days between the end of the drug supply for a prescription of the index treatment and the beginning of a next prescription for the index treatment, or the end of the one-year study period, whichever occurred first.”
Treatment switch was defined as “the initiation of a treatment other than the index DMARD within 60 days of the interruption of the index treatment.” Therapy add-on was defined as “the use of a DMARD treatment other than the treatment used at the index date for at least 28 consecutive days before the discontinuation of the index therapy.”
The authors reported that 69% of patients initiated on an oral nonbiologic DMARD had at least one therapy change during the 12-month study period (including 65% of the patients initiated with methotrexate). The median time to the first therapy change was 85 days for patients initiated on an oral nonbiologic DMARD (93 days for methotrexate patients).
Among nonbiologic DMARD users who had at least one therapy change, 83% discontinued treatment (median time: 89 days), 29% switched (median time: 113 days), and 25% had a therapy add-on (median time: 116 days).
Forty-six percent (46%) of patients initiated on a biologic DMARD had at least one therapy change during the 12-month study period. Median time to first therapy change for this group was 110 days.
Among biologic DMARD users who had at least one therapy change, 100% discontinued treatment (median time: 122 days), 25% switched treatment (median time: 173 days), and 7% had a therapy add-on with a nonbiologic DMARD (median time: 59 days).
In their discussion of these results, the authors wrote that “patient persistence with treatment was generally low and relatively brief” among patients who initiated treatment with an oral nonbiologic DMARD, with most patients who switched treatment or had a therapy add-on opting for a biologic DMARD. In fact, “only 31% of the patients persisted uninterruptedly with their initial nonbiologic DMARD therapy after one year, and slightly more than half (56%) persisted uninterruptedly with any nonbiologic or biologic DMARD after one year.”
For patients who initiated treatment with a biologic DMARD, 54% persisted with their initial therapy throughout the entire 1-year study period and 70% persisted on some form of therapy. More than 90% of patients who switched therapy opted for another biologic DMARD. This, combined with the fact that only 7% of patients had a therapy add-on with a nonbiologic DMARD, suggests that “patients initiated on a biologic DMARD tend to remain on this form of therapy and do not switch back to nonbiologic DMARDs.”
Potential reasons for therapy change from initial treatment suggested by the authors include lack of effectiveness at controlling patient symptoms and slowing disease progression, tolerability or safety issues, adverse events, and insurance-related factors (for example, the authors noted that many plans require patients to first use at least one to two nonbiologic DMARDs prior to using a biologic DMARD).
The authors conclude that the results “suggest that the majority of patients treated with nonbiologic or biologic DMARDs change therapy early after treatment initiation, with many switching to a biologic DMARD therapy or, in nonbiologic users, adding on a biologic DMARD. Among the initial biologic DMARD patients who end up switching therapies, the majority do so with another biologic DMARD (as opposed to a non-biologic DMARD).”


By J Michael Maloney MD
October 07, 2014
Category: Skin News
Tags: Psoriasis   Drugs   drug   treatment  

New Drug for Psoriasis:

Apremilast approval expanded to include plaque psoriasis

By: ELIZABETH MECHCATIE, Skin & Allergy News Digital Network

September 24, 2014

The oral phosphodiesterase-4 inhibitor apremilast is now indicated for the treatment of moderate to severe plaque psoriasis.

On Sept. 23, the manufacturer, Celgene, announced that the Food and Drug Administration had approved the expanded indication for apremilast, which was initially approved in March 2014 for treating psoriatic arthritis. The new indication is for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Approval was primarily based on the results of two multicenter, randomized, double-blind, placebo-controlled studies of adults with moderate to severe plaque psoriasis, according to Celgene. At 16 weeks, 33% and 29% of those randomized to the 30-mg, twice daily dose of apremilast had achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), compared with 5%-6% of those on placebo, according to the prescribing information.

Celgene markets apremilast as Otezla.The most common adverse events reported in studies, which affected at least 1% of treated patients and were more common than in patients on placebo, included diarrhea in 17% and nausea in 17%; other adverse events included upper respiratory infection, tension headache, and headache. The warnings and precautions section of the label includes the recommendation to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes in patients treated with the drug, and to monitor weight regularly for significant weight loss. In studies, treatment with apremilast has been associated with an increase in reports of depression and significant weight loss.


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