New atopic dermatitis drug approved - Crisaborole (Eucrisa) phosphodiesterase-4 inhibitor, applied topically twice daily

The FDA approved crisaborole (Eucrisa) as a treatment for eczema (atopic dermatitis) in patients aged 2 years and older in December 2016. The drug is a phosphodiesterase-4 inhibitor, applied topically twice daily.

What is crisaborole?

Crisaborole is a boron-based, small-molecule, topical phosphodiesterase-4 inhibitor. Chemically, crisaborole is a phenoxybenoxaborole. It contains a boron atom that helps penetrate the skin and is essential for its binding activity.

How effective is crisaborole?

Two trials with 1,500 patients showed that crisaborole treatment was better than placebo in achieving the primary endpoint, which was skin clearance or near clearance plus at least a two-point improvement in global assessment of disease severity after 4 weeks.

32% of patients receiving crisaborole achieved this endpoint, versus about 25% of the placebo groups.

Despite the strong placebo effect noted in these trials, crisaborole appears a promising nonsteroidal topical treatment for mild to moderate atopic dermatitis. Studies of longer duration than four weeks are needed to evaluate its long-term efficacy and safety.



Atopic Dermatitis Treatment - Illustrated (click to enlarge the image).

What are the side effects of crisaborole?

Adverse events were generally mild and included burning or stinging at the application site. Serious side effects of Eucrisa include hypersensitivity reactions.

Local Adverse Reactions range for 1% to 10%. Application site pain was reported in 4% of patients. Fewer than 1% had hypersensitivity reaction, urticaria. Hypersensitivity reactions have been reported, including contact urticaria. Severe pruritus, swelling, or erythema (at the application site or at a distant site) may be indicative of hypersensitivity. Discontinue immediately for signs of hypersensitivity.

Crisaborole is also under development by Anacor Pharmaceuticals for the topical treatment of psoriasis.

How much is the cost of crisaborole?

Eucrisa is a 2% ointment, marketed by Pfizer More info is available here: http://www.myeucrisa.com/

No pricing info is available as of 01/2017.

Hope on the horizon: monoclonal antibody dupilumab

Pfizer will have some heavyweight competition in the field of atopic dermatitis. Regeneron and Sanofi have lined up impressive Phase III data for the monoclonal antibody dupilumab, analysts are projecting a multibillion-dollar peak sales figure for the drug.

References:

Novel Eczema Drug OK'd - Medpage Today http://buff.ly/2ikBGe4
UpToDate, 2017, https://www.uptodate.com/contents/treatment-of-atopic-dermatitis-eczema
Pfizer racks up an FDA approval for eczema blockbuster hopeful crisaborole - EndPts http://buff.ly/2j84TGj

Allergy & asthma inheritance: It's In the genes (ACAAI video)

"When it comes to allergy and asthma symptoms and triggers, it's all in the family. Having both can be double the trouble". Allergic conditions often come in threes: allergic rhinitis, asthma and eczema, or even fours, if you add food allergy to the mix.

This is explained in the ACAAI video below:

Physician burnout, physician-patient communication and marketing advice your allergy practice - Twitter summary from #ACAAI16 meeting


Dr. Mark O'Hollaren spoke on: Reinvention of the Doctor-Patient relationship is key to physician-led healthcare transformation.

25% of employers in the US offer only high-deductible plans (i.e. $1200 USD). For patients on high deductible plans - 40% will choose not to get the tests recommended by their physicians. High deductible plans lead people to skip recommended testing. 40% will forego them.

A recent study asked if "my work schedule leaves me enough time for my personal/family life" - 63% of general population said yes, but only 36% of doctors.

What is burnout? "A progressive loss of idealism, energy and purpose" - involves emotional exhaustion, cynicism, ineffectiveness. 50-60% of physicians show evidence of burnout. Docs with stress burnout are increasing, it detrimentally impacts patient care.

Approximately 400 physicians per year in the US commit suicide. That's more than most graduating classes from medical school. Physician suicide rate higher than age matched controls. Men 40% above national rate. Women 130%!

Healthcare changes have caused a marked increase in physician burnout. The more burned out MDs are, the worse care they can provide. ICU outcomes worse where MDs score higher on testing for burnout.

Most doctors blame EMR for increased stress in practice. 73% of time on EHR only 27% with the patient! 73% of physician time spent on administrative tasks.

"Pajama time" is when physicians complete their documentation and other work at home in front of the computer. And the # 1 reason for physician stress is.....the electronic medical record. Docs spend on average 1-2 hrs at home/night with documentation.

The percentage of US physicians who have elected to work part time rather than full time increased from 13% to 17% from 2008-2014 (20,000 MDs).

Medical students start medical school with stronger mental health profiles than peers, but this reverses after 2 years of medical education.

@drstanfineman: Dr O'Hollaren shows Doctor-Patient relationship is still key even with healthcare delivery changes: https://t.co/Nrm9O0dh2i

Professional Happiness is an antidote to Burnout. Needs to come from within. Internal change is the solution. External change is unfortunately not optional, but internal change certainly is.

"External change is the cause, internal change is the solution." Dr O'Hollaren speaking on physician burnout.

Incremental process improvement will not be effective in a response to a non-linear disruptive change, it must be transformative. A sustainable health care system results in healthy patients and healthy providers. "Physician quality of life" is as important as "patient quality of life".

A burnout immunization program: Learn to say “No”, prioritize what you value, actually take vacations, acknowledge your good work. Look at what is right, look out for your team. Use your team to decrease administrative burdens. Remember to care for your 'work family' as well; craft your team to focus on wellbeing, work to connect personally with each patient.

Next step? Become aware of your local, regional & national healthcare environments, see how you as an MD can engage to steer change. We should be a student of change. Work where you can influence change.

Evidence-based recommendations on patient greeting by health care providers in this slide: https://t.co/YtPqjRVoHu

Great talk on marketing for your allergy practice by @DrStanFineman: https://t.co/N9WUnBe5dr

A/I compensation by geography from MGMA data: https://t.co/J9LPIp2K7f

Salary discrepancy among female and male allergists: https://t.co/BQWxXBrdaY

This is a Twitter summary from #ACAAI16 meeting. The post is a part of series. See the rest here: http://allergynotes.blogspot.com/search/label/#ACAAI16

Several allergists did a great job posting updates on Twitter from the 2016 meeting of ACAAI, the hashtag was #ACAAI16. I used the website Symplur to review the tweets:

@docalergias @dranneellis @drsilge @davidshulanmd @dryesimdem @allergykidsdoc @mrathkopf

http://www.symplur.com/healthcare-hashtags/acaai16/

Presentation handouts are available from the ACAAI website: http://annualmeeting.acaai.org/session_presentations.cfm

Coding and legislation issues for US allergists - Twitter summary from #ACAAI16 meeting

Helpful lecture on coding (US) for reimbursement: T48.6X6S --> underdosing Z91.120 --> financial hardship https://t.co/5okCQeWxkE

USP requirements for allergy IT in this slide: https://t.co/lE0uq36Ord

What MACRA means to allergists - timeline in this slide: https://t.co/2EgW1tqhZv

MACRA exempt for allergists for now - less than 30K in Medicare claims OR less than 100 Medicare patients: https://t.co/sNMPqK6bXd

Preparing for MACRA, slide: https://t.co/9lzYOa3ZcS

Medicare physician fee schedule 2017, increase 9 cents per RVU https://t.co/PJFuRl0bSB

Dr Kagen on working with the USP, USP was founded by physicians in 1820 in DC. USP standards: https://t.co/1MTXXDtn3b

USP goals: https://t.co/FunBPB9GxN

No contamination in 78,000 extracts prepared on countertop: https://t.co/R8tRkE4XQR

@choirdoc: After 2017, ABAI will no longer have secure "high-stakes" exam every 10 years. Will send articles, followed by test. Rational.

This is a Twitter summary from #ACAAI16 meeting. The post is a part of series. See the rest here: http://allergynotes.blogspot.com/search/label/#ACAAI16

Several allergists did a great job posting updates on Twitter from the 2016 meeting of ACAAI, the hashtag was #ACAAI16. I used the website Symplur to review the tweets:

@docalergias @dryesimdem

http://www.symplur.com/healthcare-hashtags/acaai16/

Presentation handouts are available from the ACAAI website: http://annualmeeting.acaai.org/session_presentations.cfm

Therapy for food allergy - Twitter summary from #ACAAI16 meeting

Dr Nadeau presented review of new immunotherapy for treating food allergy. Potential food allergy therapies in this slide: https://t.co/N00tHOvHIh

AR101 - 100% of patients tolerated 443g (2 peanuts) and 78% tolerated the challenge (equivalent to 1g or a peanut butter cookie) https://t.co/3QYxFVtOBO

Possible biologics for peanut allergy in this slide: https://t.co/GkO3TStDge

There is evidence the prevalence of peanut #allergy is not on the rise from comparison of longitudinal cohorts https://t.co/Ds28rZ83Cm

LEAP study: Peanut recommended to be introduced starting around 4-6 months https://t.co/ccs9HulMbz

Guidelines for peanut introduction changing. Introduce early, test if indicated. https://t.co/6MkSc8VE8Q

Peanut allergy guideline coming out Jan 2017 https://t.co/ccOjJbOyvm

However, does LEAP study applies to other foods? Early egg introduction has mixed evidence, trend towards benefit in non-eczema group but towards harm in eczema group. Very mixed picture when it comes to using hydrolyzed formula vs cow's milk formula in eczema. No clear benefit.

Socioeconomic disparity in food allergy: https://t.co/oVTh9SIKlw

Income and race influence how we utilize healthcare and incur costs: https://t.co/ZIn8WSOgDV

This is a Twitter summary from #ACAAI16 meeting. The post is a part of series. See the rest here: http://allergynotes.blogspot.com/search/label/#ACAAI16

Several allergists did a great job posting updates on Twitter from the 2016 meeting of ACAAI, the hashtag was #ACAAI16. I used the website Symplur to review the tweets:

@docalergias @drstanfineman @drsilge

http://www.symplur.com/healthcare-hashtags/acaai16/

Presentation handouts are available from the ACAAI website: http://annualmeeting.acaai.org/session_presentations.cfm



Adverse Food Reactions (click to enlarge the image).
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