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MARCH 2019    A Monthly Review of Articles of Interest for the Clinical Community

..This Month's Clinical Focus:  DERMATOLOGY..

 

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  BE ABLE 2 Extension Study Shows Long-Term Maintenance of Disease Resolution for Psoriasis Patients

The results are the longest-term data so far on bimekizumab

There are now available positive data from the Phase 2b BE ABLE extension study of bimekizumab in patients with moderate-to-severe chronic plaque psoriasis, which showed nearly all BE ABLE 1 responders completing 60 weeks of bimekizumab treatment maintained complete or almost complete skin clearance. The results further highlight the potential value of the molecule's unique dual mechanism of action, which potently and selectively neutralizes IL-17F in addition to IL-17A, two key cytokines driving inflammatory processes.
 

Clinic-tools-checklist-3222079_1920 by rawpixel PIXABAY Free Lic CC0

"The long-term results observed in the BE ABLE 2 Phase 2b study suggest the meaningful difference that IL-17F inhibition, along with IL-17A inhibition, can make for psoriasis patients who need significant, long-term skin clearance," said Andrew Blauvelt, MD, MBA, an investigator in the trial and President of Oregon Medical Research Center in Portland, Oregon. "The results add to a growing body of evidence supporting the molecule's unique dual neutralization of both IL-17A and IL-17F cytokines across multiple inflammatory diseases, suggesting exciting potential."
 

In the BE ABLE 1 study, up to 79% of patients achieved at least 90% skin clearance (PASI90) as soon as week 12, based on a dose range of 64mg, 160mg, 160mg with a 320mg loading dose, 320mg, or 480mg, administered every four weeks. Among these BE ABLE 1 responders, defined as achievement of PASI90 at week 12, 80-100% maintained the rigorous PASI90 measure for up to an additional 48 weeks based on a dose range of 160mg or 320mg, administered every 4 weeks, in the BE ABLE 2 extension study. Further, 70-83% and 78-100% of BE ABLE 1 responders maintained PASI100 and the Investigator's Global Assessment of response, respectively. The safety profile was consistent with previous studies, with no new safety findings observed. The most frequent treatment-emergent adverse events were oral candidiasis and nasopharyngitis. No cases of suicidal ideation/behavior, major adverse cardiac events, or inflammatory bowel disease were reported.
 

Bimekizumab is an investigational novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17A and IL-17F have similar pro-inflammatory functions and independently cooperate with other inflammatory mediators to drive chronic inflammation and damage across multiple tissues.  Previous early phase clinical studies in psoriasis and psoriatic arthritis have suggested that bimekizumab's unique dual neutralization of both IL-17A and IL-17F may provide a new targeted approach for the treatment of immune-mediated inflammatory diseases.
 

BE ABLE 1 included 250 patients with chronic plaque psoriasis with an affected body surface area of at least 10% and PASI of at least 12. Patients were randomized into six dosing regimens to receive either placebo or bimekizumab every four weeks subcutaneously. Randomization was balanced across treatment groups.  BE ABLE 2 included 217 responders and non-responders from BE ABLE 1. Responders receiving placebo or bimekizumab 64mg, 160mg, 160mg (320mg loading dose [LD]) remained on the same dose. Non-responders, defined as <PASI90 at week 12, were reassigned from placebo/bimekizumab 64mg to 160mg, or 160mg/160mg (LD) to 320mg. Patients previously receiving bimekizumab 320mg/480mg received 320mg.
 

SOURCE: Used by Permission of PRNewswire
 


New Data Reveals Benefits of Combining Oral and Topical Treatment in Severe Papulopustular Rosacea

 

Results of the ANSWER study see more than double the number of patients reach 'clear' (100% lesion clearance) at 12 weeks

 

First randomized clinical trial comparing the efficacy and safety of combined doxycycline 40 mg modified release (DMR) and ivermectin 1% cream (IVM), versus ivermectin 1% cream plus placebo in adults with severe papulopustular rosacea highlights a superior reduction of inflammatory lesions with combination doxycycline 40 mg modified release capsules (DMR) and ivermectin 1% cream (IVM), compared to IVM plus placebo, in adults with severe papulopustular rosacea (IGA 4*) at 12 weeks are now available.

Kids-hands-art2-227585_1920 by stux PIXABAY Free Lic CC0Clinicians often use a combination of topical and oral therapies for the treatment of rosacea. A previous study confirmed the increased benefits of combination therapy. More recently, once daily IVM has been shown to be more effective than twice daily metronidazole 0.75%.[2] The ANSWER study is the first to evaluate the combination of IVM and DMR, which is the only approved oral treatment for inflammatory rosacea lesions.
 

ANSWER is a multicenter (US, EU, CAN), randomized, vehicle-controlled, investigator-blinded, parallel-group, comparison study treating patients with severe rosacea (IGA 4) with concomitant use of topical ivermectin 1% cream (IVM) and doxycycline 40 mg modified-release (DMR) capsules. The aim of the study was to evaluate if IVM + DMR association is more efficient than IVM + placebo alone. Patients received either IVM + DMR (n= 135) or IVM + placebo once daily for 12 weeks (n= 138). Subjects were =18 years, with >20 to max. 70 inflammatory lesions (papules and pustules) on the face.
 

According to the results, the combination treatment was associated with 2.5 times more patients achieving 100% lesion clearance already at 12 weeks compared with IVM plus placebo (17.8% vs. 7.2%). DMR and IVM also worked significantly faster than IVM plus placebo, with significant differences seen as early as week 4. The safety profile of both treatment arms was generally well tolerated with no significant differences between the arms. Results showed a consistent outcome in doubling the number of patients achieving 'clear' (IGA 0) which is defined as 100% clearance in inflammatory lesions and erythema (redness) at 12 weeks using combination therapy (11.9% vs 5.1%) in this severe population.Monitoring

 

SOURCE: Used by Permission of PRNewswire


Image credits: Clinical Trial courtesy of rawpixel; Multi-hands courtesy of stux; both via PixaBay.com Free Lic CC0

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