Psoriasis

FDA Approves New Indication for Xeljanz, Xeljanz XR

By December 15, 2017

The new PsA approval was based on data from the Phase 3 OPAL Broaden, OPAL Beyond, and OPAL Balance studies.

Biosimilar Ixifi Gets FDA Approval for All Remicade Indications

By December 14, 2017

Ixifi is a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor.

Taltz Approved for the Treatment of Active Psoriatic Arthritis

By December 04, 2017

Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate.

Phase 3 Results Show Further Efficacy of Novel Plaque Psoriasis Tx

By December 04, 2017

At 16 weeks, 73% of risankizumab patients achieved PSAI 90 vs. 2% of the placebo patients and sPGA 0/1 was reached by 84% of riskanizumab patients vs. 7% of placebo patients (P<0.001).

Impoyz Cream Approved for Moderate to Severe Plaque Psoriasis

By December 01, 2017

Impoyz Cream will be available as a 0.025% cream in 60g and 112g tubes.

Body Surface Area Affected by Psoriasis May Be Linked to T2DM Risk

By November 20, 2017

To determine the risk of T2DM, researchers compared adults with psoriasis (n=8124), grouping them by affected BSA, to those without psoriasis (n=76,599); patients were followed for ~4 years.

Impact of Psoriasis Treatments on Depressive Symptoms Examined

By November 20, 2017

Psoriasis patients may be at increased risk for depression and suicidality.

Review Investigates Efficacy of Guselkumab for Plaque Psoriasis

By November 17, 2017

In the other Phase 3 trial, transitioning to guselkumab treatment was more effective than continued ustekinumab use in reducing IGA scores in those minimally responsive to ustekinmab.

Physician, Patient Survey Reveals Most Important Attributes of Psoriasis Tx

By November 17, 2017

The study quantifies the importance of clinical attributes of psoriasis therapies that dermatologists and psoriasis patients consider when choosing treatments.

FDA Accepts NDA for Topical Combination Treatment for Plaque Psoriasis

By November 02, 2017

The Prescription Drug User Fee Act (PDUFA) action date is June 18, 2018.

Alcohol May Contribute to Premature Mortality in Psoriasis Patients

By October 17, 2017

The researchers compared an cohort of patients with psoriasis (≥18 years of age) drawn from several databases to 20 patients without psoriasis who were matched by age, sex, and general practice (n=55,537 and 854,314 respectively).

Safety of Systemic Medications Investigated in Pediatric Psoriasis

By October 17, 2017

Methotrexate was the most commonly used agent (270 patients [69.2%]), followed by biologic agents, primarily etanercept (106 [27.2%]), acitretin (57 [14.6%]), cyclosporine (30 [7.7%]), and fumaric acid esters by (19 [4.9%]). Seventy-three patients (18.7%) used ≥1 medication.

Stelara Approved to Treat Adolescent Patients With Plaque Psoriasis

By October 16, 2017

The expanded approval was supported by data from a Phase 3 study that evaluated the safety and efficacy of subcutaneous Stelara in adolescents aged ≥12 years.

Secukinumab Efficacy Evaluated in Patients with Scalp Psoriasis

September 29, 2017

Over half of patients have 90 percent improvement on Psoriasis Scalp Severity Index score

Tremfya Sustains Long-Term Skin Clearance in Plaque Psoriasis

By September 18, 2017

Patients who were crossed over to Tremfya from Humira showed substantial improvement in PSSD scores from Week 48 to Week 100.

Topical Coal Tar: An Effective Alternative for Psoriasis?

August 17, 2017

Coal tar is one of the oldest psoriasis treatments though its exact mechanism is not known.

Psoriatic Arthritis Treatment Trends Investigated

By August 15, 2017

Researchers used claims data between 2004-2015 from a large commercial database to identify patients with psoriatic arthritis who were initiated on DMARDs.

First Interchangeability Study Initiated for Adalimumab Biosimilar

By July 27, 2017

Researchers will compare the pharmacokinetics and clinical outcomes between patients continuously receiving Humira vs. repeatedly switching between Humira and BI 695501.

Biosimilar Renflexis Now Available

July 24, 2017

Infliximab products work by neutralizing the biological activity of TNF-alpha by binding with high affinity to the soluble and transmembrane forms of TNF-alpha and inhibiting the binding of TNF-alpha with its receptors.

Tremfya Approved for Moderate to Severe Plaque Psoriasis

By July 13, 2017

In the NAVIGATE study, 31% of patients treated with Tremfya were considered cleared or almost cleared vs. 14% of patients treated with Stelara (ustekinumab; Janssen Biotech) at Week 28.

FDA Clears At-Home Light Therapy Device for Psoriasis

By July 13, 2017

A clinical trial (Pfaff S et al. 2015) of 47 individuals with mild psoriasis found significant improvement in change from baseline of Local Psoriasis Severity Index in patients receiving UV-free blue light home treatment.

Tofacitinib Assessed for Efficacy in Nail Psoriasis

June 20, 2017

The researchers found that significantly more patients receiving tofacitinib 5mg and tofacitinib 10mg versus placebo achieved a ≥50% reduction in the Nail Psoriasis Severity Index (NAPSI) score from baseline (NAPSI50)

Ixekizumab Beneficial in Psoriatic Arthritis Refractory to TNFi

May 31, 2017

Two-week and four-week ixekizumab dosing regimens improved signs and symptoms

Tildrakizumab to Be Reviewed for Moderate-to-Severe Plaque Psoriasis

By May 24, 2017

Ongoing data from two Phase 3 trials, ReSurface 1 and ReSurface 2, which enrolled over 1,800 patients, is included in the BLA.

Xeljanz Under FDA Review for Psoriatic Arthritis

By May 05, 2017

An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.

Out-of-Pocket Spending for Topical Steroids Investigated

May 02, 2017

The researchers found that patients' out-of-pocket spending for topical steroids was $333.7 million. There was a 226.5% increase in total annual spending, from $237.6 million to $775.9 million.

Biosimilar Renflexis Gets FDA Approval

By April 21, 2017

A biosimilar product must demonstrate no clinically meaningful differences in safety or efficacy from the reference product.

Certain Factors May Influence Biologic Tx Choice in Psoriasis

April 13, 2017

The researchers found that the presence of psoriatic arthritis, weight, employment status, baseline disease severity all affect selection

PASI Scores Differ Between Sexes in Psoriasis

April 03, 2017

Women had significantly lower scores in all areas of the body than men, except for the head, in itemized PASI analyses.

Humira Label Updated With Fingernail Psoriasis Data

By March 30, 2017

The safety and efficacy of Humira in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis was evaluated in a Phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study.