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Friday, September 14, 2018

Mayo Clinic, Medica to launch joint insurance plans

The plans will be offered nationwide, working with local providers who will funnel complex care to the Rochester, Minnesota-based health system.


KEY TAKEAWAYS

The plan will partner with local providers and refer complex cases to Mayo.
The two Minnesota-based nonprofit healthcare companies have a history of collaboration.
One skeptical observer suggests the deal is mostly ‘a marketing strategy.’
Mayo Clinic and Medica on Thursday announced plans to launch jointly developed health insurance plans that will be sold nationwide.
The two nonprofit, Minnesota-based companies said in a joint announcement that the health insurance products will tap into one another’s clinical, administration, and customer service expertise.
The plan is to partner with local healthcare systems, to ensure easy patient access to care venues. When rare and complex care is required, however, providers will have the option to send patients to Mayo Clinic.
“Mayo Clinic and Medica share a commitment to collaboration, compassion, customer service and innovation. Together, we’ve worked diligently to advance health care, improve the consumer experience and make healthcare delivery more efficient,” Medica President and CEO John Naylor said in a media statement.
“This expanded relationship will benefit not only both organizations, but also the people in the communities we serve,” he said.
In growing numbers over the past several years, hospitals have been offering health insurance plans, in large part as a bulwark against the consolidation of the health insurance industry. The private exchanges created under the Affordable Care Act have made it easier for health systems to enter the insurance market and compete with established payers.
Allan Baumgarten, a veteran observer of healthcare trends in the Midwest, said the deal “strikes me mostly as a marketing strategy.”
“It’s not described as a real joint venture health plan, like Aetna has with five provider systems or Oscar has with Cleveland Clinic,” Baumgarten says. “It sounds more like a Bright Health model of narrow networks with key provider groups, but putting out the marketing message that your doctor can refer you to Mayo Clinic—not that you can self-refer to Mayo Clinic.”
“Those provider groups probably do not include prominent academic medical centers or other large systems, because they wouldn’t want their patients to leak to Mayo Clinic,” he says.
Mayo and Medica have a history of collaboration. They’ve developed accountable care organizations for commercial group and individual markets in Southeastern Minnesota and Southwestern Wisconsin. Mayo is also a center of excellence for many of Medica’s other insurance plans.
In 2017, Medica acquired Mayo Clinic’s third-party administrator business, MMSI, Inc., which does business as Mayo Clinic Health Solutions. Customers, including Mayo Clinic staff, will transition to Medica’s technology platform and customer service model in January 2019.
“Our relationship with Medica and future product offerings support a collaborative model of care delivery and coordination of services with better outcomes for patients with complex and serious illness,” Mayo Clinic CFO Dennis Dahlen said.

Is ‘precision medicine’ the answer to cancer? Not precisely


Doctors and hospitals love to talk about the patients they’ve saved with precision medicine. But the patients who succumb to advanced cancer despite the advanced testing still vastly outnumber the rare successes.

Facing incurable breast cancer at age 55, MaryAnne DiCanto put her faith in “precision medicine” — in which doctors try to match patients with drugs that target the genetic mutations in their tumors. She underwent repeated biopsies to identify therapies that might help.
“She believed in it wholeheartedly,” said her husband, Scott Primiano of Amityville, N.Y., a flood-insurance broker. “You live on hope for so long, it’s hard to let go.”
Around this point in the average news story, readers would learn how DiCanto — mother to a blended family of five — took a chance on an experimental drug that no one expected to work.
She would be the scrappy protagonist whose determination to “keep fighting” enabled her to beat the odds — allowing us to celebrate the triumph of modern science and worry a bit less about our own mortality.
But there’s a serious problem with talking about precision medicine for cancer this way.
It misleads the public.
In spite of DiCanto’s high hopes, none of it helped. DiCanto died last year at age 59.
Doctors and hospitals love to talk about the patients they’ve saved with precision medicine, and reporters love to write about them. But the people who die — patients like DiCanto, who succumb to advanced cancer despite the advanced testing — still vastly outnumber the rare successes.
“There are very few instances in which we can look at a genomic test and pick a drug off the shelf and say, ‘That will work,'” said Dr. Nikhil Wagle, a cancer specialist at Boston’s Dana-Farber Cancer Institute who helped develop precision-medicine tests. “That’s our goal in the long run, but in 2018 we’re not there yet.”
Reflecting on his family’s experience with “precision” treatment, Primiano said, “You think it’s going to be more precise, like a laser versus a shotgun. But it’s still a shotgun.”
There has been real progress, of course.
Testing for genetic mutations has become the standard of care in lung cancer, melanoma and a handful of other tumor types. But the number of people with advanced cancer eligible for these approaches is just 9 percent to 15 percent,experts estimate. These targeted therapies help about half of patients who try them, said Dr. Vinay Prasad, an associate professor at Oregon Health and Science University.
Targeted therapies tend to be less successful in patients like DiCanto, who have exhausted all standard treatments. In a large study published last year in Cancer Discovery, precision medicine failed to help 93 percent of the 1,000 patients who signed up for the study.
At the most recent meeting of the American Society of Clinical Oncology — the largest cancer meeting in the world — researchers presented four precision-medicine studies. Two were total failures. The other two weren’t much better, failing to shrink tumors 92 percent and 95 percent of the time.
The studies received almost no news coverage.
Some experts, including Dr. David Hyman of New York’s Memorial Sloan Kettering Cancer Center, say that such testing should be available to everyone with advanced cancer, because no one can predict which individual might have a rare mutation that can be targeted with a new or experimental drug. When patients respond to these drugs, they tend to do very well, and some survive much longer than expected.
But Hyman acknowledged that many people who pursue precision medicine will be disappointed, because testing won’t lead to a new treatment. Precision medicine “is not addressing the needs of the majority of cancer patients,” he said.
Many of the doctors I interview as a health care reporter are uncomfortable talking about patients who don’t survive.
While acknowledging that not all patients are helped by tumor sequencing, they quickly pivot to talking about people they’ve saved. They rush past the disappointing present and fast-forward to a future in which every patient gets the treatment she or he needs. If you don’t listen carefully, you could easily be led to believe those future cures are already here.
There are very few instances in which we can look at a genomic test and pick a drug off the shelf and say, ‘That will work.’
Dr. Nikhil Wagle, cancer specialist at Boston’s Dana-Farber Cancer Institute
Hospitals promote their precision-medicine programs by showcasing the stories of long-term survivors. Companies such as Foundation MedicineCaris Life Sciences and Guardant Health — which sell the tests that look for cancer mutations — highlight only the best-case scenarios on their websites. In drug company marketing, patients are cheerleaders for the latest treatment fad.
Against this backdrop of hope and desperation, how are patients supposed to make informed decisions?
DiCanto gave precision medicine everything she had, including biopsies from her lungs and liver, where her cancer had spread. Over 2½ years, her doctor sent seven blood and tissue samples to specialized labs for “next-generation sequencing,” which can quickly scan hundreds of genes. The tests aim to locate a cancer’s Achilles’ heel — a genetic vulnerability that can be targeted with a drug.
DiCanto’s first genomic test matched her to a newly approved drug she would have tried anyway, Primiano said. When it stopped working, she had another biopsy.
That time, tests matched her to a different drug approved for breast cancer. But it proved so toxic that it “nearly killed her,” Primiano said.
Additional tests matched DiCanto to drugs available only in clinical trials. Eligibility criteria for clinical trials are notoriously strict, however, and often exclude people who’ve been heavily treated with other medications. DiCanto wasn’t eligible for any of them. Even when patients are eligible for trials, many turn them down. They’re just too frail and sick to travel to the metropolitan areas where most trials are run.
Although DiCanto benefited from standard cancer treatments, none of the targeted therapies recommended through genetic testing extended her life, Primiano said.
“She didn’t give up,” Primiano said. “Her body gave up. Her body just couldn’t take it anymore.”
Primiano said patients should remember that precision medicine is in its infancy. Although scientists have identified tens of thousands of genetic “variations” — changes from normal DNA that could play a role in cancer — doctors have only a few dozen drugs with which to target them. In the majority of cases, genetic mutations are of “unknown significance”; they’re essentially useless, because scientists don’t know if they affect how patients respond to drugs.
Even when drugs are a good match for a specific mutation, they don’t always work. A targeted therapy that works in melanoma, for example, doesn’t help people with colorectal cancer — even when patients have the exact same mutation, said Wagle, a member of the medical advisory board for Living Beyond Breast Cancer, a patient advocacy group in which DiCanto was active.
Paying for tests and treatment poses its own hurdles. Insurers often tell patients that next-generation sequencing is unproven. Even when insurers agree to cover the testing, they won’t necessarily cover nonstandard or experimental treatments that sequencing companies recommend.
Primiano, a insurance broker, said his family was able to handle the costs: $500,000 out-of-pocket on his wife’s cancer care over 13 years. But managing his wife’s cancer “was a full-time job — doing the research, finding the clinical trials, dealing with the insurance companies, managing the money.”
He worries about people with fewer resources, especially patients tempted to drain their savings account to pay for a treatment with little to no chance of working.
The very words “precision medicine” suggest a high rate of success, Primiano said. While its successes should be celebrated, its failures must be acknowledged and tallied, reminding us how much is left to learn. When patients and their families have so much on the line, they deserve to understand what they’re paying for.
“Let’s not pretend this is something it isn’t,” Primiano said. “I’m not saying we shouldn’t try it. I just don’t want people to have false hope.”

Allergan says study of higher doses of BOTOX meets primary endpoint


Allergan announced clinical study results of higher doses of BOTOX Cosmetic compared to BOTOX Cosmetic 20 unit dose at week 24 in patients with moderate to severe glabellar lines. Allergan conducted this trial to evaluate the duration of effect and safety of BOTOX Cosmetic 40, 60, and 80 unit doses versus BOTOX Cosmetic 20 unit dose in patients with moderate to severe glabellar lines. The primary efficacy endpoint was met and was statistically significant for BOTOX Cosmetic 40 and 80 units versus 20 unit in 226 subjects at 24 weeks. In this trial, 32% of patients were responders at week 24 in the BOTOX Cosmetic 40 unit group, 30.6% in the BOTOX Cosmetic 60 unit group, and 38.5% in the BOTOX Cosmetic 80 unit group as compared to 16% in the 20 unit group. The dose effect was observed across additional outcome variables. For responders with a greater than 1 point improvement, the time to return to baseline also demonstrated a dose-effect. The median time on the Kaplan-Meier curve was 19.7 weeks for 20 Units and 24.0 weeks for 40 Units, suggesting the median benefit of 40 units is between 20 and 24 weeks. “These study results help us better understand the BOTOX Cosmetic dose duration of effect and confirm our hypothesis that higher doses of botulinum toxin produce a longer duration of treatment effect for the treatment of glabellar lines,” said David Nicholson, Chief Research and Development Officer, Allergan. “Based on this data, doubling the dose of botulinum toxin extends the duration of effect to 24 weeks in approximately one-third of patients.”
https://thefly.com/landingPageNews.php?id=2790895

Groups Pan Proposed Medicare Changes on Office Visits, Drugs


The Trump administration in the weeks ahead must decide whether to proceed with widely derided Medicare proposals for changing payments for medical office visits and for new drugs that are administered by physicians.
The Centers for Medicare & Medicaid Services (CMS) received a barrage of negative feedback about the proposals ahead of the September 10 deadline for public comments on its draft 2019 physician fee schedule update. The final version of this rule is due to be released around November 1, 2018.
Although CMS drew praise for its attempts within the rule to reduce healthcare professionals’ administrative burden, the agency faces tough opposition to plans that groups say would cut Medicare reimbursement for evaluation and management (E/M) services.
“The proposed restructuring has generated a groundswell of opposition from individual physicians and nearly every physician and health professional organization in the country, including those whose members are projected to see increases in their Medicare payments,” said James L. Madara, MD, the American Medical Association’s (AMA’s) chief executive officer, in a September 10 letter to CMS.
The AMA asked CMS to set aside this proposal and allow an expert physician work group to develop an alternative that could be implemented in 2020.
Office or outpatient E/M services are the most common set of services billed through the giant federal health program’s payments to physicians. They accounted for 27% of the physician fee schedule in 2016, according to the Medicare Payment Advisory Commission (MedPAC). The E/M proposal in the draft rule would collapse what’s now a five-step range into two (level 1 covers initial contacts with patients often handled by other staff in a medical office, leaving levels 2 to 5 of the E/M codes of most interest to physicians). CMS’ proposal would change payment for care of new patients from a current range of $76–$211 to a single rate of $135, while pay for this care of established patients would change from a current range of $45–$148 to $93, MedPAC said in comment letter to CMS.
In August, the AMA joined 50 state medical societies and 120 national organizations, including the American Academy of Family Physicians, in a letterto CMS protesting the E/M changes. The proposal also has sparked dissent from consumer groups such as the nonprofit Families USA and AARP, the nonpartisan, nonprofit organization that represents people aged 50 years and older in policy debates.
AARP, which claims nearly 38 million members, asked CMS to stick with its existing policy until data are collected or a pilot program is conducted to see how the E/M changes would affect care of patients.
Geriatricians, neurologists, and endocrinologists, who serve many patients with serious medical conditions, would see a significant drop in payments under the new E/M rules, said David Certner, AARP’s legislative counsel, in a comment to CMS. Changing reimbursement this way could lead to cutting the time spent with patients who have complex conditions, or it could cause a shift in the amount of time a physician spends with a patient per visit, so that what is now covered in a single, lengthier visit would be covered over multiple, short visits, Certner said.
“The proposed changes may lead to individuals with complex needs having their visits cut short (thus, reducing quality of care), or they may have difficulty finding physicians who will treat them,” Certner told CMS.
Marc Weisman, DO, of Michigan Healthcare Professionals, told CMS in a comment that enacting the proposal “would be a shame for thousands of physicians” but, “much more importantly,” for millions of patients.
Weisman, who is a gerontologist, said this approach would unfairly tax the physicians who treat people with the most serious conditions. Although dermatologists do at times encounter patients with life-threatening ailments, much of their work consists of seeing people with rashes, acne, and less serious cases of skin cancers, Weisman said. “This is what allows them to operate at a clip of nearly sixty patients per day,” he said.
Gerontologists, on the other hand, routinely see people who have developed new symptoms or illnesses and who already have four or five major medical conditions.
On an average day, Weisman may see 18 people, three of whom having recently left the hospital and in need help with transition care. Although these patients may also see specialists, gerontologists must address the status of their chronic diseases and medications during visits. About one in three patients are accompanied by a family member or professional caregiver. He estimates that he spends more than 40 minutes on average with patients, not counting the time his staff spends tracking down medical information from hospitals and the patients’ other physicians.
Weisman sought to rebuff CMS’ argument that the collapsing of the E/M codes would produce significant administrative savings.
“The model, if I understand it, is predicated on the idea that if CMS requires less documentation to support the now emasculated reimbursements, we will save so much time in reduced charting that we come out ahead,” Weisman wrote. “The truth is that robust documentation will still be necessary both for medical (sharing data with other providers) and legal reasons, so there will be very little change in our administrative burden but a whopping” drop in reimbursement.

Congressional Questions

MedPAC also found fault with CMS’ E/M proposal, even after pressing the agency for years to address flaws in this billing approach.
The influential advisory panel said it supports efforts to reduce the administrative burden on physicians. MedPAC also has raised questions about “coding intensity,” or a tendency to seek more reimbursement through the E/M systems. “Just in the last five years, billing for Level 4 established patient office visits has increased — as a percentage of all such visits — from 39 percent to 45 percent while billing for Levels 1 through 3 has decreased,” wrote MedPAC Chairman Francis J. Crosson, MD, in a letter to CMS.
Still, MedPAC doesn’t support the proposed switch to a single composite rate for levels 2–5 E/M codes. Even though CMS has proposed a number of add-on codes by which most specialties would see aggregate payment changes of less than 3%, “the effect for any given clinician could be substantial,” Crosson writes.
“In particular, clinicians may be less willing to see complex patients because they would be paid the same amount for less complex and more complex patients,” writes Crosson.
CMS already is facing questions from lawmakers about the E/M proposal, Anders Gilberg, senior vice president for government affairs for the Medical Group Management Association, told Medscape Medical News.
“Congress can very much influence the outcome of this proposal in its oversight capacity, and I expect CMS will take its concerns seriously,” Gilberg said.
Two of the most influential lawmakers for health policy, for example, already have publicly raised questions about the E/M plan. Kevin Brady (R-TX), chairman of the House Committee on Ways and Means, and Rep. Peter Roskam (R-IL), chairman of that committee’s health panel, praised many of CMS’ efforts to reduce the administrative burden on physicians in a September 4 letter to CMS Administrator Seema Verma. But they said the E/M proposal may be “an oversimplification that could have unintended consequences.”
“We ask that you take a more deliberate approach working with stakeholders, and consider a policy with at least three coding categories, including considerations such as patient risk scores in addition to time spent, to ensure higher levels of accuracy while still reducing burdens,” Brady and Roskam write.
Brady and Roskam also raised concerns with CMS’ plan to alter how Medicare pays for new medicines administered by physicians.
For most drugs, CMS pays a nominal premium of 6% to the reported average sales price (ASP) of a drug. Federal budget cuts reduce the actual payment to about 4.4%. For newer drugs, CMS rules call for adding a 6% add-on to the wholesale acquisition costs (WAC), as there is not yet enough data for the ASP price. In the draft physician fee rule, CMS is proposing to drop the additional payment to a 3% add-on to WAC during an initial phase-in period. Brady and Roskam told CMS that this proposed cut “could create incentives to use less innovative drugs.”
Medical groups, including the AMA and the American Society of Clinical Oncology, told CMS that they oppose this proposal. In a comment to CMS, the American Association of Clinical Urologists said CMS’ attempt to reduce costs of new drugs for Medicare and the people covered by it would put independent medical practices in financial jeopardy. The group instead urged a closer look at the complex system of rebates linked to pharmacy benefit managers, which can result in higher prices for medicines.
“The ever-increasing launch prices for drugs and biologics are a direct result of the broken system that allows corporate players to exploit the various complex and opaque relationships to increase their own profits at the expense of physicians and patients,” the urologists’ group said.
CMS did get support, though, for the proposed change to Medicare payment for new drugs covered by its Part B program. MedPAC’s Crosson called this approach “a modest, positive step toward lowering drug costs for beneficiaries and the Medicare program.”

R.J. Reynolds: FDA to continue evaluation of Camel Snus modified-risk claims


R.J. Reynolds said the Tobacco Products Scientific Advisory Committee, a scientific advisory committee of the U.S. Food and Drug Administration, “recognized that the available science supports that switching completely from cigarettes to Camel Snus can significantly reduce smokers’ risk of lung cancer and respiratory disease, although the committee was evenly divided on claims regarding oral cancer and heart disease.” To date, the FDA has not issued an MRTP marketing order. The FDA will take the TPSAC’s recommendation into consideration as it independently evaluates and makes a determination based on its own review. “We appreciate the committee’s thoughtful and robust discussion of the specific language that should appear in modified-risk advertising for Camel Snus and are pleased it agrees with some of our proposed messages. The committee’s insight should be of great value to the FDA, and we look forward to working with the FDA as it evaluates our applications,” said James Figlar, executive VP of research and development of R.J. Reynolds. R.J. Reynolds Tobacco is an indirect subsidiary of Reynolds American Inc., which is an indirect, wholly owned subsidiary of British American Tobacco.

$100M-plus IPO for off-the-shelf CAR-T player Allogene?


Back in early April, Arie Belldegrun and David Chang were just getting started when they rolled out news of a $300 million round for a startup company called Allogene and their deal to take over Pfizer’s R&D group and pipeline focused on developing the world’s first off-the-shelf CAR-Ts.

Another $120 million flowed in just a few days ago.
Along the way, the crew found time to write an S-1 with $100 million penciled in for the next raise, looking to take the funding past a half billion dollars in 6 months time.
They’ll need it. By the end of June, they had spent $137 million — $111 million of that registered as an accounting expense for the asset acquisition — while taking a sublet from Pfizer. In August, the S-1 says they landed a lease on a new headquarters space in South San Francisco, a booming biotech hub that has attracted scores of startups that want to be within a short drive of Genentech. And the plan is to go early in building a new manufacturing operation — which won’t be cheap.
They’re moving into the old Exelixis building at 210 East Grand.
Belldegrun and Chang have done it all before, but in nothing like the speed they’re traveling now. The pair built Kite from the ground up and sold it to Gilead for $12 billion, giving both a personal fortune — part of which Belldegrun has reinvested back into his new VC Vida Ventures, an investor in Allogene.

This time, they’re out to replace personalized CAR-T — which relies on cells extracted from patients, then weaponized and infused back in to fight cancer — with an industrialized approach that would allow for a one-size-fits-all technology.
The most advanced program they have in the clinic — UCART19 — is managed by their partner Servier. According to the latest data they have from early stage work on ALL:
As of April 2018, 13 out of 16 evaluable patients, or 81%, achieved a complete response (CR) and 12 of those patients, or 92%, achieved a minimum residual disease negative CR (MRD- CR). The most common adverse events were related to cytokine release syndrome (CRS) and were generally manageable. Two mild graft-versus-host disease (GvHD) cases in the skin were observed and resolved. We expect UCART19 to be advanced to potential registrational trials in the second half of 2019.
An IND is on its way next year for ALLO-501 in NHL and ALLO-715, targeting BCMA for the treatment of patients with drug resistant multiple myeloma.
Belldegrun has reserved 14% of the shares, while Chang has a 5% stake. The investors are topped by TPG Carthage Holdings at 25.1% and Pfizer, which got 24% for the program. They’re followed by Gilead, which has an 8.4% stake.
The company plans to trade as $ALLO.

Serious Infection Risk with Biologics for Atopic Dermatitis


Off-label use of biologic agents to treat refractory atopic dermatitis posed a significant risk of serious infection as compared with systemic nonbiologic agents, data on almost 400,000 patients showed.
A propensity-matched analysis showed that treatment with a biologic agent doubled the risk of hospitalization for a serious bacterial or opportunistic infection as compared with high-potency topical steroids or nonbiologic systemic therapy. Infection risk also varied substantially among nonbiologic systemic agents, with cyclosporine posing the lowest risk and azathioprine and mycophenolate the greatest risk, as reported here at the European Academy of Dermatology and Venereology congress.
“This is the largest comparative safety evaluation of its kind to date in adult patients with atopic dermatitis,” said Mia Schneeweiss, a student at Harvard Medical School and Brigham and Women’s Hospital in Boston. “Biologics were associated with a greater risk of serious infection requiring hospitalization than either nonbiologic systemics or topical steroids.”
The analysis did not include patients treated with newer biologic agents specifically approved for atopic dermatitis, such as dupilumab (Dupixent). Investigators intend to update the analysis with data on outcomes with the newer agents, as well as long-term outcomes with all the treatments, she added.
The study had its genesis in the increasing use of systemic nonbiologic immunomodulatory drugs and systemic biologic agents to treat atopic dermatitis that is inadequately controlled by topical steroids. Mixed results have emerged from studies use of biologic agents to treatment recalcitrant atopy; however, experience with systemic biologic and nonbiologic agents in other conditions (such as psoriasis and rheumatoid arthritis) has shown an increased risk of bacterial infections, Schneeweiss noted.
“Few population-based studies have evaluated the safety of off-label use of these systemic agents for treating severe atopic dermatitis,” she said. “Additionally, comparative safety data among nonbiologic and biologic immunomodulatory agents in the treatment of atopic dermatitis is limited.”
In an effort increase the evidence base, investigators undertook an analysis of a commercial insurance claims database encompassing 2003-2016 and 180 million lives. They used diagnostic codes to identify all adults with a diagnosis of atopic dermatitis and initiating treatment. Patients with other indications for any of the medications of interest (psoriasis, arthritis, organ transplantation, etc.) were excluded.
The primary outcome was first occurrence of hospitalization for a serious bacterial or opportunistic infection. Patient characteristics were assessed 6 months before the study and followed for an additional 6 months.
The study consisted of two cohort analyses. The first involved patients who initiated treatment with a low-potency topical corticosteroid and subsequently had treatment escalation to one of three therapeutic categories: high-potency topical corticosteroids, biologics and disease-modifying drugs (including anti-TNF agents, rituximab [Rituxan], and tofacitinib [Xeljanz], and nonbiologic systemic therapy (methotrexate, cyclosporine, azathioprine, prednisone, and mycophenolate).
The second cohort comprised patients who started treatment with any type of topical corticosteroid and subsequently had treatment escalation to a biologic or systemic nonbiologic agent.
The first cohort included 396,734 patients who initiated treatment with a high-potency topical corticosteroid and 403 patients who started treatment with a biologic agent. The second cohort included 153,890 patients who initiated treatment with a systemic nonbiologic agent and 2,116 who who started a biologic drug.
In the first cohort, patients who escalated to a high-potency topical steroid had a total of 1,039 qualifying hospitalizations for serious infection, resulting in a rate of 2.62 per 1,000. That compared with 16 events in the 403 patients who initiated treatment with a biologic agent, resulting in a rate of 39.70 per 1,000. An unadjusted analysis produced a relative risk of 15.16 for patients treated with biologics.
The second cohort analysis showed 1,239 hospitalizations for infection in the patients who were new users of systemic nonbiologic agents (8.05/1,000) versus 47 hospitalizations among new users of biologic therapies (22.21/1,000). Comparison of the two groups yielded a relative risk of 2.76 for the patients who received biologic therapy.
A multivariate analysis with propensity matching yielded similar relative risks for the two cohorts: 2.74 for the comparison of biologics versus high-potency topical corticosteroids and 2.16 for the comparison of biologics versus systemic nonbiologic agents.
Investigators also compared the relative risk of infection-related hospitalization for the five systemic nonbiologic agents. Cyclosporine emerged with the lowest overall relative risk, ranging from 0.17 to 0.55 in comparisons with other four systemic nonbiologic, followed by prednisone and methotrexate. Mycophenolate was associated with the highest relative risk (1.64 to 5.88), and azathioprine had a two- to fourfold higher risk versus all other agents except mycophenolate (0.61).
Schneeweiss reported having no relevant disclosures. Co-investigator Joseph F. Merola, MD, disclosed relationships with Biogen/IDEC, AbbVie, Amgen, Eli Lilly, Novartis, Pfizer, Janssen, UCB, Samumed, Celgene, Sanofi, Regeneron, Merck, and GlaxoSmithKline.