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MARCH 2017    A Monthly Review of Articles of Interest for the Clinical Community

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<This Month's Clinical Focus:>

<DERMATOLOGY>

 

New Head-to-Head Data Shows Significantly Higher Response Rates for Lilly's Taltz® (ixekizumab) Compared to Stelara® (ustekinumab)


Lilly presented 24-week data at AAD comparing the efficacy and safety of Taltz and Stelara for the treatment of moderate-to-severe plaque psoriasis.

Patients with moderate-to-severe plaque psoriasis treated with Taltz ® (ixekizumab) demonstrated superior efficacy at 24 weeks compared to patients treated with Stelara ®* (ustekinumab). Detailed results from the IXORA-S study were presented during the American Academy of Dermatology (AAD) Annual Meeting March 3-7 in Orlando, Fla.

At 24 weeks, patients treated with Taltz achieved significantly higher response rates compared to patients treated with Stelara, including 83 percent of patients who achieved Psoriasis Area Severity Index (PASI) 90—the study's primary endpoint—compared to 59 percent of patients who achieved PASI 90 after treatment with Stelara.  "For many years, achieving PASI 75 – or 75 percent improvement in skin plaques – has been the standard treatment goal for moderate-to-severe plaque psoriasis," said Kristian Reich, M.D., Ph.D., lead author and professor, Georg-August-University Göttingen and Dermatologikum Hamburg, Hamburg, Germany. "With the introduction of treatments like Taltz, dermatologists can offer treatment options that allow more patients to achieve PASI 90 or PASI 100 [1].

Psoriasis Rx shutterstock_274834217 PAID LIC

The data of the IXORA-S study is significant, as it demonstrates both high levels of skin improvement for patients treated with Taltz, consistent with pivotal Phase 3 trials, as well as higher response rates over Stelara, which is one of the most frequently used biologics in the treatment of moderate-to-severe plaque psoriasis."

In the IXORA-S study, patients were randomized to receive either Stelara (45 mg or 90 mg weight-based dosing per label) or Taltz (80 mg every two weeks for 12 weeks followed by 80 mg every four weeks), following a 160-mg starting dose, for a total of 52 weeks.

At 24 weeks, patients treated with Taltz achieved significantly higher response rates compared to patients treated with Stelara, as demonstrated by the following:
•91.2 percent of patients treated with Taltz achieved PASI 75 compared to 81.9 percent of patients treated with Stelara (p=0.015);
•83.1 percent of patients treated with Taltz achieved PASI 90 compared to 59.0 percent of patients treated with Stelara (p<0.001);
•49.3 percent of patients treated with Taltz achieved PASI 100 compared to 23.5 percent of patients treated with Stelara (p=0.001).

Additionally, 86.6 percent of patients treated with Taltz achieved sPGA 0 or 1 compared to 69.3 percent of patients treated with Stelara after 24 weeks (p<0.001).

The majority of treatment-emergent adverse events were mild or moderate. There were no statistically significant differences between treatment groups in overall treatment-emergent adverse events. The safety profile for Taltz was consistent with previous clinical trials. "The approval of Taltz in the U.S., Canada and Europe nearly one year ago introduced a treatment option that could help patients with moderate-to-severe plaque psoriasis achieve virtually clear or completely clear skin," said Dr. Lotus Mallbris, global brand development leader, Taltz, Eli Lilly and Company.

Results from Phase 3 trials evaluating Taltz for the treatment of active psoriatic arthritis are expected to be presented later this year. Taltz is also in Phase 3 trials for the treatment of axial spondyloarthritis.


Reprinted with permission from PR Newswire via RePubHub
Source: Eli Lilly and Company; [1] Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64:ii65-ii68. http://ard.bmj.com/content/64/suppl_2/ii65.full. Accessed March 1, 2017.
 


BioPharmX Society of Toxicology Poster Suggests Promise of BPX-01 as Topical Acne Therapy

 

Studies suggest drug is well tolerated and a promising advance in topical acne therapy, novel topical gel BPX-01 delivers acne-fighting medication to the target area safely without systemic side effects.

A poster on the research, titled " BPX-01 Toxicological Evaluation of 1% Topical Minocycline Gel," was presented at the 55th Annual Meeting of the Society of Toxicology (SOT) meeting. The SOT meeting is one of the world's largest gatherings of toxicologists.

Oral minocycline is a routinely prescribed antibiotic for the treatment of acne , but because it delivers the active drug systemically, there can be undesirable side effects, such as upset stomach, diarrhea, dizziness and headache. BPX-01 [1] is the first fully solubilized and stable topical gel formulation of minocycline, which had previously been demonstrated to penetrate the skin and to the pilosebaceous unit where acne develops. BPX-01 may improve bioavailability and enable the use of a lower dosage of the drug, which pre-clinical and clinical studies suggest thus far does not enter the blood system in measurable quantities.

Acne Tx shutterstock_445272361 sm_web PAID LIC

"One of the issues that concerns me the most with our current treatment options for moderate-to-severe acne is the systemic exposure to antibiotics, which can lead to antibiotic resistance and other unwanted side effects," said Dr. Joely Kaufman, board certified dermatologist and investigator for the BioPharmX Phase 2b study of BPX-01. "In my practice I try to minimize the length of time a patient is on oral antibiotics to avoid systemic side effects."

"The research to date suggests that BPX-01 topical gel delivers low but potentially efficacious dosages of minocycline to target areas," said Kin F. Chan, executive vice president of research and technology at BioPharmX. "BPX-01 offers promise to millions of people who cannot take oral minocycline to treat their acne, including young children, pregnant women and the many people who are intolerant of systemic antibiotic treatments."

This is the second year BioPharmX is appearing at the SOT meeting. Last year, company researchers shared non-clinical safety and toxicokinetic data for BPX-01.  This year's presentation provides an overview of the non-clinical program with special focus on the study data from longer drug exposures with comparisons to the earlier data.

BioPharmX is currently conducting the OPAL (tOPicAL Minocycline Gel) study – a Phase 2b dose finding clinical trial to assess the efficacy and safety of BPX-01 for the treatment of acne vulgaris. The 12-week, multi-center, randomized, double-blind, three-arm, vehicle-controlled study involves 225 individuals, aged 9 to 40, who have moderate-to-severe inflammatory, non-nodular acne vulgaris.


Reprinted with permission from PRNewswire via RePubHub;
Source: BioPharmX Corporation
; [1] Caution: BPX-01 is a new drug limited by U.S. law to investigational use.


Image credits: provided by paid license from Shutterstock


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