Highlights From the 2022 ACR Research Conference: Part 1

Read the latest arthritis research recently presented at the 2022 American College of Rheumatology (ACR) Convergence conference, which attracted health care providers, clinicians, researchers and patients from around the world.

The 2022 American College of Rheumatology (ACR) Convergence conference recently took place in Philadelphia, Pennsylvania, attracting health care providers, clinicians, researchers and patients in person from around the world for the first time in three years.
 
Listen to the Live Yes! With Arthritis Podcast covering more 2022 Arthritis Research Highlights from the conference.
 
Here is part one of our two-part series featuring highlights of the latest in science and research presented this year (click here for part two).
 

2022 Rheumatology Year in Review

Carol Langford, MD, director of Cleveland Clinic’s Center for Vasculitis Care and Research, focused on some of the clinical trials from the year that were innovative and/or might affect how doctors make decisions about treatments.
 
Some highlights from the year’s clinical research included several trials that led to the approval of new drugs and insights into treatments into conditions including gout, lupus, rheumatoid arthritis (RA) and COVID-19.
 
A randomized controlled trial looked at the benefits and harms of giving the corticosteroid prednisolone to people 65 and older with active RA. Participants received either prednisolone or placebo in addition to their usual care. The results showed that joint damage slowed in those who received the drug more than those who didn’t. However, they also lost bone mineral density in their spine and had 24% more adverse events, or serious side effects. So older RA patients should be wary of taking this common corticosteroid as part of their usual treatment.
 
Dr. Langford also revisited a study to test the safety of tofacitinib (Xeljanz). The study, which the FDA required of the manufacturer as part of the drug’s approval, had found that using tofacitinib raised cardiovascular and cancer risks in people aged 50 and older with active RA who had at least one cardiovascular risk factor (such as hypertension, being a smoker, or having diabetes or high blood pressure). The findings led the FDA to require boxed warnings on tofacitinib as well as other drugs in the same class, called Janus kinase (JAK) inhibitors. Two others used for arthritis and related conditions are baricitinib (Olumiant) and upadacitinib (Rinvoq).
 
However, it wasn’t clear which cardiovascular risk factors and which patients were at greater risk and whether some might not be at risk. Several follow-up studies have looked at that, including one focusing on patients with atherosclerotic cardiovascular disease (CVD), which involves the buildup of plaque and hardening of arteries. The results showed a higher incidence of heart attack, stroke or cardiovascular death in those with atherosclerotic CVD who took tofacitinib, suggesting that the drug should be used with caution in people with a history of atherosclerotic CVD or those over 65.
 
Questions remain about the safety of the other JAK inhibitors. Although they are in the same class and work in similar ways, they affect different receptors on the cellular pathway. More research is needed, particularly because those medications have been approved in the past year to treat several additional conditions.
 
A gout trial looked at adding methotrexate — a drug commonly used in many rheumatic conditions, but not typically for gout — to pegloticase (Krystexxa), which is a drug given by infusion for gout in patients whose gout has not responded well enough to other treatments. After six months of adding the methotrexate, 71% of participants had the goal serum acid level (high serum acid typically fuels gout) compared to 39% of those receiving placebo. This led the FDA to expand approvals for pegloticase to include its use with methotrexate. There are risks associated with methotrexate, however, including immune suppression, “which is not something we typically consider in the treatment of gout,” Dr. Langford added.
 
She also discussed a trial that led to the approval of intravenous immune globulin to treat dermatomyositis, a disease that involves muscle inflammation and skin rash. Another looked at adding tocilizumab (Actemra) to prednisone to treat polymyalgia rheumatica (PMR), a condition that causes widespread muscle pain, especially in older adults. Adding tocilizumab to prednisone — the mainstay treatment for PMR — helped lower disease activity and allowed patients to reduce or stop the prednisone in the trial, but both medications carry some risks. Tocilizumab also was approved earlier in 2022 to treat giant cell arteritis, which often occurs with PMR.
 
In the lupus arena, Dr. Langford discussed a much newer kind of treatment: chimeric antigen receptor (CAR) T cells. This therapy uses gene-modified cells to target bad actors at the cellular level and is currently used for certain types of cancers. It involves removing blood from the patient to add a gene sequence to their T cells. The blood is then infused back into the patient, where an enzyme is released that destroys targeted cells, leading to an “immune reset.” A small study of five people aged 18 to 24 with systemic lupus erythematosus (SLE) who had not responded to multiple other therapies found that CAR T cell therapy led to improvements in all five participants, with four showing no disease activity by three months and maintaining remission at eight months. There are risks, however, of cytokine release syndrome, which occurs in 50% to 90% of patients receiving this therapy. Cost and safety concerns remain, “but it’s an innovative approach and longer follow-up in larger numbers is needed to see if remission persists,” Dr. Langford added. Several other trials focused on three other drugs that may also treat lupus using different pathways and mechanisms. All had positive results, but some had concerning side effects, and more research is needed.
 
While COVID-19 has become part normalized for many people, it continues to affect people with rheumatic disease more aggressively. A systematic review published in 2022 that included 14 databases and 100 studies found that those with rheumatic disease have a 52% higher risk of contracting COVID than the general population and a higher risk of poor outcome with a 74% increased risk of death, Dr. Langford said. Most of those who got COVID were on immunosuppressant medications. A follow-up study looked at a drug combination — tixagevimab and cilgavimab (tix-cil) — as a COVID-19 preventive in people with severe immunosuppression. It found that those who took tix-cil were half as likely to develop COVID-19 as those who didn’t and 92% less likely to be hospitalized or die. The FDA has granted tix-cil emergency use authorization. Now marketed as Evusheld, it is given as an injection every six months. (The FDA has more recently warned that the product is not effective against certain variants of the coronavirus.) —JILL TYRER

 
FDA: Pediatric Update
 
This presentation by representatives from the Food and Drug Administration (FDA) focused not only on the response process to drug shortages, but also on approvals of existing drugs for additional rheumatic conditions in children.
 
New drugs or existing drugs used for new conditions typically have had to go through long, expensive trials to prove that the drugs are safe and effective. But in 2019, FDA representatives and experts in pediatric rheumatic conditions met to discuss ways of accelerating drug approvals for children with these diseases. One of the outcomes was the concept of extrapolating approvals based on safety and effectiveness of a drug that is already being used in adults with highly similar diseases and/or in children with other diseases, explained Amit Golding, MD, PhD, senior physician in FDA’s Division of Rheumatology and Transplant Medicine. Each drug is evaluated for both safety and effectiveness using a systematic process. Drug approvals in the past year for pediatric rheumatic conditions include the following:
 
  • Belimumab (Benlysta) was already in use by adults with systemic lupus erythematosus (SLE) or lupus nephritis as well as in children aged 5 or older with SLE. It was approved in July 2022 for use in children with lupus nephritis. “This is notable … as the first product to be approved for pediatric patients with lupus nephritis, a population with significant unmet medical need,” Dr. Golding said.
  • Ustekinumab (Stelara) was approved in August 2022 to treat children ages 6 to 17 with active psoriatic arthritis (PsA). It was previously approved to treat psoriasis and PsA in adults as well as plaque psoriasis in children.
  • Secukinumab (Cosentyx) was approved in December 2021 to treat PsA in children ages 2 to 17 and enthesitis-related arthritis (ERA) in ages 4 to 17 — the first drug approved in the U.S. to treat juvenile ERA. In this trial, all participants received secukinumab and most showed improvements in their PsA and/or ERA. After 12 weeks, participants received either secukinumab or placebo, and then evaluated over time for the number and frequency of flares. Researchers found the risk for flares among the juvenile PsA patients was 85% lower for those who received secukinumab than those who got placebo and 53% lower for ERA patients. The drug was already approved to treat pediatric psoriasis, and no new safety issues were identified.
In addition, seven biosimilars for adalimumab (Humira) were approved for children aged 2 and older with juvenile idiopathic arthritis (JIA) and for pediatric Crohn’s disease for ages 6 and older. They are expected to launch in 2023. Two biosimilars for etanercept (Enbrel) were approved for JIA and pediatric psoriasis but are not yet on the market in the U.S. Adalimumab and etanercept are already approved to treat these conditions in children, and their biosimilars must meet the same standards in order to be approved. A biosimilar must be “highly similar to and have no clinically meaningful differences from the FDA-approved reference product” — in these cases, adalimumab and etanercept. They must have the same dosage form and strength and be manufactured to the same standards of safety, purity and potency. One of these has also been approved as “interchangeable,” meaning it has been tested to be repeatedly swapped with the “reference product” and shown to have no meaningful differences. Products approved as interchangeable may be swapped out without a doctor’s order. —JILL TYRER
 

Studies found that those with rheumatic disease have a 52% higher risk of contracting COVID than the general population and a higher risk of poor outcome with a 74% increased risk of death. —Carol Langford, MD

 
FDA Update on Safety Issues in the Treatment of Rheumatic Disease
 
Food and Drug Administration representatives discussed drugs that have been approved in the past year to treat additional diseases, new drug safety concerns, and they gave further updates on COVID-19 treatments, biosimilars and interchangeables. They also discussed drug development for rheumatoid arthritis and psoriatic arthritis.

The FDA approved the following biologic and targeted disease-modifying antirheumatic drugs (DMARDs) in the past year to treat additional conditions:
 
  • Tofacitinib (Xeljanz) was approved to treat ankylosing spondylitis (AS) in adults with active AS that hasn’t responded adequately to tumor necrosis factor (TNF) inhibitors.
  • Upadacitinib (Rinvoq) was approved to treat adults with active psoriatic arthritis (PsA), active AS or active non-radiographic axial spondyloarthritis (nr-axSpA) whose disease hasn’t responded to TNF inhibitors. (It also received approval for ulcerative colitis and atopic dermatitis.)
  • Secukinumab (Cosentyx) is the first drug to receive approval for enthesitis-related arthritis for children aged 4 and older, and its approval was expanded to include pediatric PsA in children ages 2 and older.
  • Risankizumab (Skyrizi) was approved for the treatment of active PsA in adults (as well as plaque psoriasis and Crohn’s disease). It does, however, have additional warnings, explained presenter and rheumatologist Sabiha Khan, MD, a medical officer in the FDA’s Division of Rheumatology and Transplant Medicine. Among them are risks of serious reactions, like anaphylaxis, serious infections and tuberculosis.
  • Belimumab (Benlysta) was approved for lupus nephritis in children aged 5 and older — the first drug approved for pediatric lupus nephritis.
  • Ustekinumab (Stelara) approval was expanded to include PsA in children ages 6 and older as well as adults.
  • Tocilizumab (Actemra) infusion was approved to treat giant cell arteritis, an inflammatory disease that affects the large blood vessels in the scalp, neck and arms.
  • Baricitinib (Olumiant) was approved to treat adults hospitalized with COVID-19.
  • Pegloticase (Krystexxa) in combination with methotrexate was approved to treat gout that hasn’t responded to standard therapies.
Raj Nair, MD, a rheumatologist, acting team leader and medical officer in FDA’s Center for Drug Evaluation and Research (CDER) Division of Rheumatology and Transplant Medicine, focused on drug safety issues that have been found in the past year.
 
  • In a 52-week trial that led to the approval of methotrexate to be given with pegloticase for gout (for patients who don’t get an adequate response from conventional therapy), 71% of the participants taking both drugs achieved the target uric acid level compared to 31% of those receiving pegloticase alone. There are concerns about staying on pegloticase for longer terms, but a 12-month follow-up showed that 60% of those on the combination were still achieving the target uric acid versus 31% of those on pegloticase alone. Folate supplementation is recommended. Most side effects were reactions to the infusion, but only 4% receiving the combination had a reaction compared with 31% receiving only pegloticase. There was, however, one case of anaphylaxis, so caution is still warranted.
  • Risankizumab (Skyrizi) has been found to be associated with “small increases” in liver-related side effects, Dr. Nair said. The most common side effects were rash, rhinitis and facial swelling, but there was one case of anaphylaxis. The drug is also used to treat Crohn’s disease, but in much higher doses than for PsA or psoriasis. One case of “liver injury” from the drug occurred in those trials.
  • Biologics that target interleukin-23, which plays a role in the immune system, include ustekinumab, guselkumab, tildrakizumab and risakizumab. They are associated with hypersensitivities (potential anaphylaxis) and infections, and guselkumab and risakizumab may also have potential liver effects.
Other updates focused on immunomodulator drugs used in rheumatology that also have received emergency use authorization (EUA) in the past year to treat COVID-19. They include tocilizumab (Actemra), anakinra (Kineret) and baricitinib (Olumiant). All are recommended for use in hospitalized patients who need oxygen or mechanical help to breathe. Tocilizumab and baricitinib are also authorized for use in children ages 2 and older.
 
“There remains a need for new treatments for COVID-19 given the persistently high death and hospitalization tolls,” said Suzette Peng, MD, captain in the U.S. Public Health Service and clinical reviewer in the FDA’s Division of Rheumatology and Transplant Medicine. “According to the CDC, COVID-19 is still responsible for more than 350 deaths per day and more than 4,400 new hospital admissions per day in the U.S.”
 
Dr. Peng also gave some updates on biosimilars used to treat a variety of diseases, including cancers and autoimmune conditions. (As patents expire for the original, brand-name drugs, or “reference products,” more biosimilars are being developed and marketed.) The FDA has received meeting requests to discuss the development of biosimilars for 47 reference biologics, she said. It has received 60 biologic license applications and approved 38 biosimilars — 22 of which are on the market — and three have been approved as interchangeable, meaning they have gone through additional testing to ensure they can be switched with their reference product multiple times without any change in effectiveness or safety. Plus, 106 biosimilar product development programs are in progress.
 
Dr. Peng also gave a recap of a meeting between the American College of Rheumatology and the FDA focusing on drug development for RA and PsA. “Achieving minimal disease activity or remission has become a realistic goal and having patients sub-optimally treated for prolonged periods of time is no longer appropriate,” she said. The discussion focused on ways to reduce the use of placebo in drug trials and to enhance collaborations and alternative approaches to test drugs to benefit patients. —JILL TYRER
 

Latest COVID and Rheumatic Disease Therapies
 
Rachel Perritt, PharmD, and Stephen Saw, PharmD, both of the University Hospital of Pennsylvania, discussed vaccination and therapies for people with arthritis in the age of COVID.
 
COVID is a fast-moving and slippery target. Research is being published at an astounding pace, with 300,000 peer reviewed articles, 50,000 articles on pre-peer review servers and six billion citations on Google in the last two-plus years. But research can be contradictory and outdated, so it’s best to keep checking updates on the CDC website.
 
Managing medications before and after a COVID shot
 
  • People on hydroxychloroquine (Plaquenil) or intravenous immune globulin (IVIG) can continue their meds as usual.
  • Hold injectable abatacept (Orencia), belimumab (Benlysta), mycophenolate mofetil (CellCept) and JAK inhibitors including baricitinib (Olumiant), tofacitinib (Xeljanz), and upadacitinib (Rinvoq), for or one to two weeks after each dose and booster, when possible.
There are no clear vaccination timing recommendations for people taking tumor necrosis factor (TNF) blockers or interleukin (IL)-6, IL-17, IL-1, IL-23 or IL-12/23 inhibitors.

Effectiveness of vaccines based on medications
 
  • People taking TNF, IL-17, IL- 12/23 and IL-6 inhibitors may have a greater than 90% response to the COVID-19 vaccine.
  • Patients on prednisone, belimumab, hydroxychloroquine, leflunomide (Arava), methotrexate (Trexall, Rasuvo), JAK inhibitors and mycophenolate might have a 70% to 90% response.
  • Patients taking Rituximab (Rituxan) are unlikely to mount much of an immune response to the COVID vaccine but should still receive it to help reduce the chance of severe illness.
If you test positive
 
  • If you test positive for COVID and are at high risk, your doctor will likely suggest a combination drug called Paxlovid that’s given within five days of infection. Note: Paxlovid can cause a rebound case of COVID, which may be milder or worse than the original illness. COVID symptoms can rebound even if you don’t use Paxlovid.
  • If you can’t take Paxlovid due to liver or kidney disease or because you take medications that can cause a severe reaction to it, the drug molnupiravir (Lagevrio) may be an option. It’s about one-third as effective as Paxlovid and isn’t safe during pregnancy.
  • If you have symptoms for more than seven days, your doctor may recommend treatment with a SARS-CoV-2 monoclonal antibody, such as remdesivir (Veklury).
  • During COVID infection, you should stop all arthritis drugs for at least two weeks, with the possible exception of sulfasalazine (Azulfidine) and an IL-6 inhibitor like tocilizumab (Actemra). Carefully discuss the risks and benefits of continuing medication with your doctor. —LINDA RATH

ACR Guidelines for Vaccinations in People with Rheumatic Diseases
 
Ann Bass, MD, Hospital for Special Surgery and Weill Cornell Medicine, Clifton Bingham, MD, Johns Hopkins and Kevin Winthrop, MD, Oregon and Health and Sciences, explained new American College of Rheumatology (ACR) recommendations for vaccines — minus COVID shots — for rheumatic disease patients.
 
People with rheumatic diseases are more prone to vaccine-preventable infections and have more serious consequences of infection. Because the effectiveness and safety of common vaccines can vary in rheumatic disease patients, some may need modified vaccination schedules and medications.
 
Some key takeaways from the ACR guidelines:
 
  • High dose or adjuvanted flu vaccine is recommended over the standard dose for adults aged 18 and older taking immunosuppressive drugs. Since these recommendations are outside the approved age range, insurance may not cover this type of flu shot. Discuss your flu vaccine options with your doctor and insurance company.
  • Adults on immunosuppressive drugs should get the pneumonia vaccine — pneumococcal conjugate vaccines (PCV 13, PCV15, and PCV20) and pneumococcal polysaccharide vaccine (PPSV or PPSV23). The type of pneumonia vaccine and vaccine schedule depend on your age, health and previous vaccinations.
  • Shingrix, a recombinant herpes zoster vaccine, is recommended for adults on immunosuppressant drugs to help prevent shingles — the reactivation of the chicken pox virus.
  • Adults aged 26—to 45 taking immunosuppressants may want to consider the HPV vaccine.
  • Holding methotrexate for one to two weeks can improve response to flu and COVID shots. No data exists for other vaccines.
  • Patients using rituximab (Rituxan) should delay vaccines as long as possible after the last rituximab treatment.
Read on for more detailed information on vaccinations, including the newest COVID boosters. —LINDA RATH

Read more about the latest arthritis research in part two of our coverage of the 2022 ACR Convergence conference.
 
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