The coming year in rheumatology brings with it a variety of trends and concerns about how rheumatologists can chart the best course for their practices and patients amid mounting fiscal and regulatory pressures.

Questions also arise as to how rheumatology can improve its attractiveness to students and residents in 2016 with the current level of effort in mentoring, outreach, and competition against higher-paying subspecialties.

There’s also high interest and expectations in the new year for studies on systemic sclerosis and microbiome research, as well as questions about what the future holds for intra-articular hyaluronic acid and over-the-counter topical nonsteroidal anti-inflammatory drugs for osteoarthritis (OA).

Rheumatology News editorial advisory board members gave their thoughts on these areas of rheumatology in 2016.

Insurance and reimbursement problems

The changing landscape in insurance plans, brought about largely by the Affordable Care Act, is having a big impact on patients and physicians, particularly in Florida, where more than 1.5 million people signed up for an ACA federal marketplace plan in 2015. Difficulty in accessing and affording care in 2016 figures to be an even greater problem, said Dr. Norman Gaylis, who is in private practice in Aventura, Fla.

In general, many policies are passing an increased burden onto patients in regard to deductibles, copayments, and costs of medications, he said. “That’s putting tremendous stress on practices. I think this is nationwide, where we’re finding that rheumatology patients are not getting access to the drugs for [several] reasons: they’ve become unaffordable, the various pharmaceutical support programs have run out of money, and the amount of work that practices are now performing in trying to get authorization for the patients far exceeds any type of revenue [it] could be generating or should be generating to cover these increased costs. So essentially there’s a reduction in reimbursement and a reduction in revenue going along at the same time.”

Dr. Gaylis noted that there is “tremendous pressure” from all sides to reduce access to rheumatology drugs, which have rising costs. For instance, the cost of a monthly supply of generic celebrex in his practice’s area is on average $120-$200, “which is almost prohibitive for many of our patients.”

“We’re finding that this year [2015] alone, 20% of patients who are on standard infusion therapy as a routine part of their management of rheumatoid arthritis have basically dropped out,” he said. “If that’s equal across the board, that means a very high number of patients are not getting optimal care.”

The trend for rheumatologists, particularly those in solo practice, to make contracts with fewer insurance companies could accelerate in 2016, Dr. Gaylis said.

Some rheumatologists are beginning to not accept insured patients with coverage from managed care companies or the lower-tier payers, and “that’s a significant trend if it starts evolving because it will create a two-tiered system in that you’ll have the more affluent patient going to one of these practices, and then you’ll have clinics where you’ll have a totally different level of care.” Whether it builds up enough to where rheumatologists begin to develop hybrid concierge practices is a fair question, he said. “It’s very difficult to conceive of a patient paying for both primary care and subspecialist concierge service. But I am starting to see signals where there may well be some integration between concierge primary care and concierge subspecialties.”

Training, mentoring more rheumatologists

Another issue going into 2016 is the lack of mentoring and assistance to medical students and residents to draw them to the subspecialty and keep them there, as well as the viability of rheumatology as an attractive subspecialty. “It’s difficult to see how we can attract medical students and residents to the specialty when the cost of their education leaves them with staggering bills to be paid. You’ve got to be extremely passionate to want to be a rheumatologist,” Dr. Gaylis said.

Dr. Elizabeth Volkmann, clinical instructor in rheumatology at the University of California, Los Angeles, agreed and said she looked forward to seeing how the future of mentoring programs in rheumatology will progress in 2016 and beyond. She noted that the American College of Rheumatology (ACR)/Childhood Arthritis and Rheumatology Research Alliance Mentoring Interest Group (AMIGO), a career-mentoring program that serves most fellows and many junior faculty in pediatric rheumatology across the United States and Canada, recently reported success in establishing mentor contact, suitability of mentor-mentee pairing, as well as benefit with respect to career development, scholarship, and work-life balance, and was especially useful to fellows, compared with junior faculty (Arthritis Care Res. 2015 Sep 28. doi: 10.1002/acr.22732).

Dr. Volkmann expressed interest in seeing how the ACR’s Choose Rheumatology! mentorship program is performing. The program seeks to pair students and residents with rheumatologist mentors who will offer advice and help to guide them. She also pointed to the European League Against Rheumatism’s working group for young rheumatologists, the Emerging EULAR Network (EMEUNET), which seeks to promote the educational, research, and mentoring needs of young clinicians and researchers in rheumatology in Europe. as a potential model for the ACR to use in the United States.

Some of the conference-based resources available to rheumatology fellows include the ACR’s 2016 State-of-the-Art Clinical Symposium, which provides a presymposium course specifically for fellows and has sessions on choosing career paths, and the Rheumatology Research Workshop, which targets rheumatologists interested in pursuing an academic research career. Fellows-in-training travel scholarships are available for both conferences.

New systemic sclerosis and microbiome research

Many new studies in systemic sclerosis will build on results obtained in earlier-phase trials or unanswered questions arising out of treatment comparison studies. “It is a very exciting time in the world of scleroderma,” said Dr. Virginia Steen, professor of medicine at Georgetown University, Washington.

At least four new trials are studying treatments for skin manifestations of systemic sclerosis, noted Dr. Steen. In patients with diffuse cutaneous systemic sclerosis, the phase II ASSET study is testing abatacept (Orencia) against placebo and another phase II study is testing riociguat (Adempas). Roche has started enrolling patients for a phase III trial of tocilizumab (Actemra) on the heels of positive findings from its phase II study. Dr. Steen and colleagues at Johns Hopkins University are also finishing up a pilot study of the effects of intravenous immunoglobulin (Privigen) on skin disease in systemic sclerosis and should have results ready for 2016.

Two additional trials will be investigating treatments for interstitial lung disease associated with systemic sclerosis: the Scleroderma Lung Study III, testing the use of mycophenolate mofetil in all patients with the addition of pirfenidone (Esbriet) or placebo, and a separate phase III study of nintedanib (Ofev) vs. placebo that just began enrolling patients.

There are also several trials of add-on therapies, including topical nitroglycerin for Raynaud’s phenomenon or riociguat for digital ulcers, and another that is testing autologous adipose–derived regenerative cells for the treatment of hand dysfunction.

In addition to these trials now underway, the expected 2016 publication of the validation of the Combined Response Index for Systemic Sclerosis will hopefully “lead to real movement forward in the treatment of systemic sclerosis,” said Dr. Daniel E. Furst, the Carl Pearson Professor of Medicine at University of California, Los Angeles.

Further examination of the Wnt signaling pathway in systemic sclerosis should also bring better insights into the disease’s pathogenesis and potential for treatment, Dr. Furst noted, as recent experimental results have shown that its activation induces fibroblast activation with subsequent myofibroblast differentiation and excessive collagen release. Small-molecule inhibitors of Wnt signaling in early clinical trials have shown promising results.

Dr. Furst and Dr. Volkmann said they also hope for studies describing better and more specific data regarding the microbiome in rheumatic disease, especially systemic sclerosis and rheumatoid arthritis, both of which have microbiome data linked with clinically meaningful outcomes (Nat Med. 2015 Aug;21[8]:895-905).

An important unanswered question, Dr. Volkmann said, is whether differences found in GI microbial composition between diseases and between different disease subtypes are clinically meaningful.

OA treatments: AAOS guidelines, OTC topical NSAIDs

The repercussions of the American Academy of Orthopaedic Surgeons 2013 clinical practice guideline’s statement on intra-articular hyaluronic acid treatment of knee OA will continue to be felt in 2016, according to Dr. Roy D. Altman, professor emeritus of medicine at University of California, Los Angeles.

The AAOS took a different stance from all other recent treatment guidelines for knee OA by stating: “Intra-articular hyaluronic acid is no longer recommended as a method of treatment for patients with symptomatic osteoarthritis of the knee.” The AAOS’s recommendation didn’t create much confusion with physicians and patients because its use continues to increase, but instead it has contributed to “a plethora of contradictory publications and increasing resistance on coverage by insurance carriers,” Dr. Altman said.

Another unresolved issue in OA treatment is “the resistance of the FDA to approve over-the-counter topical NSAIDs,” Dr. Altman said. The FDA requires a new drug application for OTC topical NSAIDs demonstrating efficacy and safety, “as if they were completely new,” when the safety exceeds presently approved OTC oral NSAIDs and has already been shown for prescription topical NSAIDs, he said.

jevans@frontlinemedcom.com

Rheumatology trends, research, concerns highlighted for 2016