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Methotrexate More Beneficial in Psoriasis Without Concomitant Arthritis

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The investigators sought to compare the efficacy and safety of methotrexate to treat psoriasis in patients with and without psoriatic arthritis.
The investigators sought to compare the efficacy and safety of methotrexate to treat psoriasis in patients with and without psoriatic arthritis.

According to a study published in JAMA Dermatology, methotrexate is safe and effective as first-line treatment for patients with psoriasis. It is also more effective and better tolerated in patients without arthritis compared with patients with concomitant psoriatic arthritis.

The investigators of this prospective, single-center, observational study sought to compare the efficacy and safety of methotrexate to treat psoriasis in patients with and without psoriatic arthritis.

The study sample included 235 adults diagnosed with psoriasis recruited from a large university hospital in China: 128 participants with moderate-to-severe psoriatic arthritis and 107 without psoriatic arthritis. The participants all received a 12-week course of low-dose methotrexate therapy from April 2015 to December 2017. Severity and extent of psoriasis were assessed using the Psoriasis Area Severity Index and body surface area scores; blood cell counts, liver enzyme levels, and renal function were also measured at baseline and at weeks 4, 8, and 12. The primary outcomes of interest were changes in disease severity and adverse events.

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Clinical and demographic differences between patient groups with and without psoriatic arthritis were not significant; however, the investigators noted that the psoriatic arthritis group had a higher rate of diabetes. The proportion of participants who achieved a 90% reduction in Psoriasis Area Severity Index scores from baseline to week 8 was significantly lower in patients with psoriatic arthritis vs patients without psoriatic arthritis (3.1% vs 11.2%; P =.02). This trend continued through week 12, with 14.8% of patients with psoriatic arthritis achieving a 90% reduction in scores vs 25.2% of patients without psoriatic arthritis (P =.049). At week 12, 41.4% of patients with psoriatic arthritis and 50.5% without (P =.19) achieved a 75% reduction in scores.

Most treatment-associated adverse events were reported as mild or moderate, and no participants dropped out due to severe adverse events. The incidence of adverse events was significantly higher in patients with psoriatic arthritis vs patients without psoriatic arthritis, including reports of dizziness (9.4% vs 0.4%; P =.007), gastrointestinal symptoms (25.0% vs 12.1%; P =.01), and hepatoxicity (26.6% vs 15.0%; =.04). A methotrexate-induced elevation of liver enzyme alanine aminotransferase was more frequent in patients with arthritis and was associated with increased body mass index and smoking in both patient groups.

Limitations to the study included a short treatment course of 12 weeks and a single-center setting, limiting the generalizability of the findings. Folic acid supplementation was not prescribed with treatment, and therefore, gastrointestinal symptoms may have been overestimated.

Methotrexate to treat psoriasis was effective and well tolerated, however, it was less effective in patients with psoriatic arthritis. Additionally, more patients with arthritis reported adverse events, including dizziness and abnormal hepatic function. Risk factors of smoking and increased body mass index were associated with elevated alanine aminotransferase levels, which were significantly more frequent in patients with psoriatic arthritis. Therefore, methotrexate is recommended as first-line therapy for psoriasis patients without arthritis.

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Reference

Yan K, Zhang Y, Han L, et al. Safety and efficacy of methotrexate for Chinese adults with psoriasis with and without psoriatic arthritis [published online January 30, 2019]. JAMA Dermatol. doi: 10.1001/jamadermatol.2018.5194

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T Cell Lymphopenia May Enhance Effectiveness of Fumaric Acid Ester Therapy for Psoriasis

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The main finding of this study was that the numbers of CD4+T, CD8+T, CD19+B, and CD56+NK cells were significantly reduced by treatment with FAEs.
The main finding of this study was that the numbers of CD4+T, CD8+T, CD19+B, and CD56+NK cells were significantly reduced by treatment with FAEs.

Increased pharmacovigilance by additionally monitoring distinct T cell subset count in addition to absolute lymphocyte counts may provide more meaningful insights into the safety and efficacy of fumaric acid esters (FAEs) for the treatment of psoriasis, according to a study published in the Journal of the European Academy of Dermatology and Venereology.

This investigator-initiated subcohort study reviewed continuously recorded clinical and laboratory findings in patients with psoriasis (N=371) who were prescribed Fumaderm® between January 1996 and October 2012. Investigators quantitatively analyzed peripheral blood lymphocyte subsets data using flow cytometry before and during treatment with FAEs. All patients received monthly clinical assessments and quarterly complete blood count tests. The following antibodies were used: T lymphocytes (CD3+), helper T lymphocytes (CD3+CD4+), cytotoxic T lymphocytes (CD3+CD8+), B lymphocytes (CD19+), and natural killer (NK) cells (CD3-CD16+CD56+).

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The main finding of this study was that the numbers of CD4+T, CD8+T, CD19+B, and CD56+NK cells were significantly reduced by treatment with FAEs. The mean lymphocyte count was significantly decreased by 23.9% within the first 3 months of treatment, and the counts continued to decrease over the course of treatment by approximately 40% of baseline values. The mean CD4+T cell and the mean CD8+T cell counts each declined significantly by 49.9% and 55.7%, respectively. The CD19+ B cell and CD56+ NK cell counts also decreased significantly by 27.7 % and 21.9 %, respectively, compared with mean baseline values.

This study was limited by its utilization of a retrospective data set. The data reported reflect the clinical experience of a single tertiary care center and may not be representative of the entire population of patients with psoriasis.

Based on their findings and long-term experience, the authors suggest that periodic monitoring of CD4+ and CD8+T cell counts in intervals of 4 months or fewer, in addition to monthly complete blood count and lymphocyte count, seems to be clinically relevant for making therapeutic decisions regarding continual and long-term use of FAEs.

Disclosures: This study was partly supported by Biogen GmbH, Ismaning, Germany. Please see the original reference for a complete list of authors’ disclosures.

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Reference

Dickel H, Bruckner T, Höxtermann S, Dickel B, Trinder E, Altmeyer P. Fumaric acid ester-induced T cell lymphopenia in the real-life treatment of psoriasis [published online January 24, 2019]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15448

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Periodontal Health Should Be Monitored Closely in Patients With Psoriasis

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Patients with psoriasis reported significantly higher values for parameters that address periodontal inflammation.
Patients with psoriasis reported significantly higher values for parameters that address periodontal inflammation.

In patients with psoriasis, regular periodontal checkups are recommended and periodontal treatment should be initiated as soon as possible whenever required.

Recognizing that available data on the periodontal and dental status of patients with psoriasis are scant, study investigators conducted a prospective study in which individuals with psoriasis were compared with controls, and the results of their analysis were published in the Journal of Investigative Dermatology.

A total of 100 patients with plaque psoriasis (mean age, 47.4±14.7; range, 19 to 79) who presented at the outpatient service of a specialized psoriasis center, department of dermatology, University Medical Center Schleswig-Holstein, Campus Kiel in Germany and 101 controls without psoriasis (mean age, 46.9±16.8; range, 18 to 86) were enrolled in the study. Standardized measures were utilized to evaluate oral health, including Bleeding on Probing (BOP), Community Periodontal Index (CPI), and dental parameters based on the DMFT-index (cumulative index: total of teeth registered as decayed [“D”], missing [“M”], and filled [“F”]).

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A Psoriasis Area and Severity Index (PASI) <10 was observed in 96% of patients with psoriasis, with 4% reporting a PASI >10. No treatment was administered in 9% of patients with psoriasis, whereas 25% were receiving topical therapy and 66% were receiving systemic therapy (50% on biologic agents, 21.2% on methotrexate, 21.2% on fumaric acid esters, 4.5% on systemic combination therapy, and 1% on other systemic treatments).

A post-matching strategy was applied for analysis, with 53 pairs of patients with psoriasis and controls without psoriasis in whom relevant factors with a possible impact on oral health status were taken into account. Results of the study demonstrated that the matched group of patients with psoriasis had significantly higher BOP values (P <.011) and CPI (P <.002) values compared with matched controls. Per logistic regression analyses, significant correlations were identified in the psoriasis group with high BOP and CPI values, but not with missing teeth. Moreover, patients with psoriasis reported significantly higher values for parameters that address periodontal inflammation.

The investigators concluded that based on the findings from this study, patients with psoriasis should undergo regular dental checkups on periodontal status and should receive any required treatment where necessary.

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Reference

Woeste S, Graetz C, Gerdes S, Mrowietz U. Oral health in patients with psoriasis – a prospective study [published online January 2, 2019]. J Invest Dermatol. doi:10.1016/j.jid.2018.12.014

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Axial Disease More Common in Psoriatic Arthritis With Acute Skin Problems

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Acute skin manifestations correlated with axial disease and were more common among young participants and those with higher body mass index. <i>Photo Credit: BSIP/Science Source</i>
Acute skin manifestations correlated with axial disease and were more common among young participants and those with higher body mass index. Photo Credit: BSIP/Science Source

Among individuals with psoriatic arthritis (PsA) and moderate to acute skin manifestations, axial disease is more common and has an earlier onset, according to a study recently published in the Journal of Dermatology. Additionally, anti-tumor necrosis factor-α inhibitors (anti-TNF- α) have demonstrated reduced efficacy among individuals older than 50 years.

This cross-sectional, retrospective study included 2116 individuals with psoriasis and was conducted in western Japan. Medical records were gathered and psoriasis and PsA were analyzed by physicians according to the Classification Criteria for Psoriatic Arthritis. Categorical data were examined using Fisher’s exact test and continuous variables by Student’s t-test, with confounding factors removed through logistic regression.

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In this cohort, 13.5% (n=285) had a diagnosis of PsA. This was preceded by skin manifestations in 69.8% of cases, with a median time of 7 years between skin manifestations and arthritis onset. The 2 conditions occurred at the same time among 17.2%, and just 2.5% showed PsA before skin manifestations. The majority of cases were peripheral arthritis (73.7%), followed by dactylitis (35.4%), enthesitis (23.5%), and axial disease (21.8%). Acute skin manifestations correlated with axial disease (P =.03) and were more common among young participants (P =.01) and those with higher body mass index (P =.02).

TNF-α inhibitors were administered to 157 participants and were continued by 105, with 47 discontinuing them. This discontinuation correlated significantly with being older at the time of joint manifestations (50 vs 44 years; P =.01) and being older in general (55 vs 51 years; P =.04). Those older than 50 years were 3.65 times  more likely to discontinue TNF-α inhibitors (P <.01).

Limitations to this study included that the cohort exclusively included Japanese participants, a cross-sectional study design, and a lack of longitudinal observation.

The study researchers concluded that “13.5% of individuals with psoriasis in our large survey had PsA. Our finding that axial disease is present more frequently in patients with moderate [or] severe manifestations is new, as is the finding that TNF inhibitors are less effective in older patients with PsA, suggesting the presence of other overlapping conditions.”

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Reference

Tsuruta N, Narisawa Y, Imafuku S, et al. Cross-sectional multicenter observational study of psoriatic arthritis in Japanese patients: relationship between skin and joint symptoms and results of treatment with tumor necrosis factor-α inhibitors [published online January 10, 2019]. J Dermatol. doi: 10.1111/1346-8138.14745

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Dermatology, Infectious Disease Collaboration May Optimize Detection of Sexually Transmitted Infections

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Over the study period, significant increases in the number of screening tests, as well as the ratio between the tests and hospital admissions, was observed.
Over the study period, significant increases in the number of screening tests, as well as the ratio between the tests and hospital admissions, was observed.

Collaboration between dermatology and infectious disease clinics may help improve the diagnosis of sexually transmitted diseases such as syphilis, HIV, hepatitis B (HBV), and hepatitis C (HCV) in at-risk populations, according to results of a study that examined a collaborative effort by 2 Italian clinics. Results were published in the Journal of the European Academy of Dermatology and Venereology.

The investigators sought to analyze the number of screening tests performed in the dermatology and infectious disease clinics and to compare results obtained following adoption of the shared protocol with findings from the prior period. A secondary objective of the study was to assess the linkage with care of people newly diagnosed with sexually transmitted diseases. Consecutive patients who were referred to the clinics between January 2010 and December 2016, with ≥1 serologic screening test performed for HIV, HBV, HCV, and syphilis, were enrolled in the study.

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Over the 7-year observation period, a total of 13,117 admissions for 9154 patients were gathered. Over the study period, significant increases in the number of screening tests, as well as the ratio between the tests and hospital admissions, was observed (P <.001 and P =.002, respectively).

Overall, 7.0% (644 of 9154) of individuals were diagnosed with ≥1 infection. Among the infections, the most common were syphilis in 41.9%, HBV in 25.7%, HCV in 21.4%, and HIV in 10.9%. Syphilis was reported primarily among Italians (72.5%) and men (75.7%), similar to HCV, whereas foreign-born individuals had mainly HBV infection (85.5%). Additionally, HIV was diagnosed more often among men (67.1%), with a similar proportion observed among Italians and foreign-born patients. Linkage to care was reported among 84.3% (543 of 644) of patients. 

The investigators concluded that accurate epidemiologic information about the distribution of sexually transmitted diseases is key for targeting screening, as well as for designing, implementing, and assessing intervention programs.

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Reference

Mandel VD, Tullio FD, Rugge W, et al. Optimization strategies for HIV, hepatitis and syphilis testing in infectious disease clinic and dermatology unit of Modena: seven-years results of collaboration experience [published online December 6, 2018]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15390

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Protecting Patient Privacy: HIPAA Compliance in the Electronic Age

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E-mail accounts and passwords of former employees should be immediately deactivated so they can no longer access the network.
E-mail accounts and passwords of former employees should be immediately deactivated so they can no longer access the network.

The privacy of patient data is protected by the Health Insurance Portability and Accountability Act (HIPAA) and the 2009 Health Information Technology for Economic and Clinical Health Act.1But the complexities of today’s high-tech methods of communication, data sharing, and data storage lay practices open to unforeseen and constantly changing threats, requiring vigilance and training of medical staff.

This second article devoted to cybersecurity takes a closer look at protecting patients’ privacy. To gain further insight into this complex subject, MPR interviewed Michael J Sacopulos, JD, CEO of Medical Risk Institute (MRI), a firm that provides “proactive counsel” to the healthcare community to identify where liability risks originate and to reduce or remove those risks. He is also General Counsel to Medical Justice Services. Mr Sacopulos is the coauthor of Tweets, Likes, and Liabilities: Online and Electronic Risks to the Healthcare Professional (Phoenix, MD; GreenbranchPublishing: 2018).

What do you think the greatest threat is to HIPAA in physicians’ practices?

Some of the issues I discussed in our previous interview are central in potential HIPAA violations. In particular, I’m talking about lack of cyber-hygiene, by which I mean the numerous human errors that can compromise patient privacy, even with the best software and firewalls. We already discussed the importance of training staff not to click into unknown e-mails often called “phishing” e-mails, which are cyber attacks that open the door to hackers to access your system or install malware on your computers. Teaching your staff to recognize these scams and malware e-mails is critical.

What other potential concerns might compromise privacy?

An important area of concern is the location where you and your staff access any practice-related Internet. If you have an employee, consultant, or contractor who works remotely – for example, a bookkeeper or someone who does medical billing – you need to be sure that several important things are in place.

Neither you nor your employee should be using the free Wi-Fi at Starbucks or the library or the airport, for example, to do any e-mailing or work on patient records, since those are not secure connections and can easily be hacked. Additionally, in a public place, a person sitting near you, or a passerby can catch a glimpse of a patient’s name or some other information or might even use their own cellphone to photograph it.

Employees who work from home should have a dedicated work space, such as a home office, with a door that closes and file cabinets that can be locked and secured from others. The office shouldn’t double as the guest room or children’s bedroom. And the employee should dedicate specific time and space to working on practice-related matters and not multitask. I’ve seen situations in which the person who does billing was working on generating electronic bills while trying to cook dinner for her family and having the computer or paperwork on the table.

Any conversations about patients, whether you are returning a patient’s call or whether your staff member is talking to an insurance company, should be conducted in private where no family members or others can hear you. One doctor was discussing a child’s bedwetting problem with a parent within earshot of his own children. It was a small town and the doctor’s children went to school with the child who had the bedwetting issue. Soon, it was public knowledge in the classroom and the other children teased the boy with the problem. This took place in the days before HIPAA was put into place, but the issue could just as easily take place today if patient-related conversations could be overheard.

Equally important is making sure there is a dedicated computer used for nothing other than practice-related matters. The computer should have a secure password and should not be shared by others, such as one’s children who are using it to do their homework or play video games.

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Are there any software-related issues to be concerned about?

You should have good firewalls proper encryption for patient portals and modes of communication. It is extremely important to keep software supported and up to date. If the manufacturer recommends updates, they must be installed promptly so that your software remains secure. Updates are “patches,” which the manufacturer recommends if they find vulnerabilities. Older versions of software eventually are no longer supported by the platform, such as Microsoft. Beyond being unreliable, outdated software is vulnerable to cyber breaches. The government’s position is that if the software is not supported, this constitutes a per se violation.

How can a practice increase its security?

I cannot emphasize enough what I mentioned in the previous interview, which is to engage a professional IT expert to conduct and troubleshoot software issues or handle phishing e-mails and potential breaches. A professional IT expert should also conduct an annual risk analysis and advise on what needs improvement.

You should regularly review who in your practice has access to which type of information. Staff members who do not need to access patients’ electronic health records (EHRs), meaning they are not involved with the care of a given patient, should be prevented from accessing that patient’s records. The e-mail accounts and passwords of former employees should be immediately deactivated so they can no longer access your network. This is equally true if you have a storage area of paper files. The ex-employee’s key or swipe card should be returned and if there is a combination lock, the combination should be changed.

Lastly, make sure you have policies in place regarding your employees’ use of social media and e-mails and access.

What about the use of mobile devices?

Any cellphone used for your practice has to be password protected, so that if it gets lost or stolen, any information is secure. Most standard Androids and iPhones today have passwords that are encrypted and therefore secure.

Another concern relates to texts. Are your texts secure or not? And, equally important from a patient safety perspective, does the content of the text ever make its way into the patient’s chart? Conversations between physicians over text, or between the physician and the patient, need to be entered into the chart for continuity of care and so that if the phone is lost or stolen, no important patient information is lost.

If a physician or other practitioner uses a cellphone to photograph a patient — for example, a dermatologist has photographed a patient’s rash — this should also be entered into the patient’s chart as soon as possible.

Are there any other concerns related to photographs and patient privacy?

There are some obvious concerns. No photographs of a patient should appear anywhere outside of his or her chart — for example, nothing should ever be posted on the practice’s Website or newsletter, or on an employee’s social media.

I know that physicians sometimes use close-up photographs of de-identified patients at medical meetings for demonstration or to discuss a particular disease or condition — perhaps a rash or surgical incision. But the law is very clear that the picture can’t be identifiable as any particular person to anyone else, even a spouse.

I had a case in which a woman had a breast augmentation and the surgeon took a before/after picture of her torso, which was later used in a medical presentation — without identifying information, of course, and without revealing any other body parts such as face, head, arms or legs. But the patient brought a suit claiming that she had a unique freckle pattern on her chest that could be identifiable to some people. The case was settled.

My advice is to obtain a patient’s permission if you want to use any images in a conference or a journal article. This can be done quite easily with a one-page document that should remain in the patient’s chart. In my experience, very few patients will refuse to allow their de-identified photograph to be used if they understand that it is for the purpose of medical education of other healthcare professionals.

As cumbersome as it can be to set up appropriate protocols and adequately train staff, it is essential, not only to protect you from potential litigation or disciplinary action but also to protect patient privacy and enhance patient safety.

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Reference

1.    McCoy TH, Perlis RH. Temporal trends and characteristics of reportable health data breaches, 2010-2017. JAMA. 2018;320(12):1282-1283.

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Nuzyra Now Available in IV, Oral Forms for CABP, ABSSSI

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Nuzyra is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.
Nuzyra is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.

Paratek announced the launch of Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). It is the first once-daily antibiotic approved to treat CABP and ABSSSI that is available in both an intravenous (IV) and oral formulation.

Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains. Specifically, it is indicated for CABP caused by Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae and ABSSSI caused by S. aureus (methicillin-susceptible and -resistant isolates), S. lugdunensis, S. pyogenes, S. anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and K. pneumoniae.

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Concurrently, Paratek announced the availability of 3 FDA-approved antimicrobial susceptibility tests (Hardy Diagnostics’ Omadacycline Susceptibility Disk [HardyDisk], Liofilchem Omadacycline MIC Test Strip, and Thermo Scientific Sensititre MIC Plate) to help guide clinicians toward the appropriate use of Nuzyra, and the KEYSTONE Surveillance Program, which provides access to current antimicrobial surveillance susceptibility data.

Nuzyra is available as 150mg strength tablets in 6-, 14-, and 16-count blisters, and as a 100mg lyophilized powder for IV infusion (after reconstitution and dilution) in single-dose vials.

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For more information call (833) 727-2835 or visit Nuzyra.com.

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