Dr. Liew
Dr. Liew: Patient education and empowerment are important. Curate helpful and reputable patient-directed resources. These can be found on the SAA website, www.spondylitis.org. Creaky Joints (www.creakyjoints.org) is another great resource, with educational materials and news articles vetted by clinicians.
Consider the comorbidities in your patients. I think we’ve gotten better at considering comorbidities in lupus, for example. Comorbidities are important for the care of axSpA as well. Think about cardiovascular disease, especially screening for risk factors such as hypertension (very common), hyperlipidemia and diabetes. Think about depression. Think about poor sleep.
Continue to emphasize physical therapy and exercise. There are continued benefits for inflammation and disease activity even in those with disease that is fairly well controlled on biologic therapy. There are educational materials available online, including videos for exercises and stretches that patients can do at home, from the U.K.-based National Axial Spondyloarthritis Society (NASS).
TR: What if you can’t get the insurer to authorize a treatment for nr-axSpA because it’s only approved for axSpA?
Dr. Gensler: Well, I don’t use the nr-axSpA diagnostic code, especially as we think about this blurry line that distinguishes non-radiographic from radiographic disease. I also don’t use ‘AS’ unless it is absolutely clear/classic as patients may then struggle to get disability/life insurance. I am able to use an ‘axial spondyloarthritis’ code in our EPIC electronic health record system, and I have never had a problem with a biologic based on these terms. Nr-axSpA is an indication, but only for a few specified biologics. I might still get denials, but a brief peer-to-peer conversation almost always resolves the denial.
Dr. Hwang: We understand that almost 20% of axSpA patients have peripheral symptoms. An emphasis on that aspect at times can be helpful. Also, because nr-axSpA is part of the continuum of axSpA, I don’t view these as separate diseases.
Dr. Liew: This was more of an issue before the FDA approved certolizumab pegol for nr-axSpA. Also, before there was a new International Classification of Diseases (ICD) code for nr-axSpA. Before this, people would code everything as ‘AS’ so that patients could get MRIs and could get biologic therapies. And this is fine and shouldn’t impact clinical care—but it does impact observational research using administrative or claims data where only ICD codes are available for diagnoses. It makes it hard for researchers to use these data to study AS or nr-axSpA as separate populations. (Brief epidemiology lesson: This study design issue is called misclassification.)
TR: We would love to hear your final thoughts. Any important pearls or points of interest to share with rheumatology professionals?
Dr. Gensler: AxSpA patients used to be easy to diagnose; the disease is now [recognized as] more heterogeneous and, therefore, more challenging to identify correctly, with many mimics to consider. Patients often come to us after years of disease. They know their disease, and this is often more comfortable than the unknown medications we are offering. When treating these patients, consider the non-pharmacologic interventions as similarly important as the medications we prescribe. It takes me several visits to build a therapeutic alliance before they are willing to consider escalation from NSAIDs. This is less of an issue in patients with short disease duration. Finally, what a joy to care for a group of patients that present to us in their 20s and 30s—we get to share in their many life milestones. The depth of those relationships is priceless.
Dr. Hwang: While it has its own struggles, I have really enjoyed co-managing my axSpA patients with other disciplines and services, specifically but not limited to dermatology, physical therapy and ophthalmology. This has allowed me to glean better understanding of their specialties and I believe our synergy has allowed us to improve our patients’ lives.
Dr. Liew: For trainees interested in axSpA or who just want to learn more, SPARTAN has an annual meeting in May with a full day dedicated to a trainee symposium. I’ve attended this symposium either live or virtually every year since 2018 and I’ve gotten something out of it each time. SPARTAN is committed to educating trainees, as well as supporting research and educational efforts. There are research grant opportunities to fellows, we are doing more educational outreach beyond rheumatology, and we are thinking of ways to connect fellows with mentors outside of their own institutions. Visit the website (www.spartangroup.org) or follow on Twitter @SPARTAN_Updates.
‘The distinction of radiographic axSpA & nr-axSpA is a gray area, technically differentiated by the burden of sacroiliac joint damage on radiograph.’ —Lianne S. Gensler, MD
It’s been a tough year with the pandemic, with many changes to the practice of rheumatology and with restrictions on in-person meetings (among other things). A bright light has been the expansion of virtual learning, as well as virtual platforms for seminars and webinars. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and SPARTAN put out a series of monthly lectures to cover clinical practice and current research in axSpA and psoriatic arthritis. These videos are available for viewing for free.
THE DRUGS
Note: For all drugs discussed, refer to the company websites for the full prescribing information and all Important Safety Information (ISI).
*Important Safety Information*
This ISI is applicable to all tumor necrosis factor inhibitors (TNFi’s) and some other biologic agents.
Serious Infections & Malignancies
- There is an increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis) and infections due to other opportunistic pathogens. If these develop, discontinue the drug.
- Patients should be tested for latent TB prior to starting the drug and during therapy. Treatment for latent TB should be initiated prior to starting the drug. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with the drug, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent TB is needed prior to initiating the drug, even for patients previously vaccinated with Bacillus Calmette-Guerin (BCG).
Adalimumab (Humira):7 injection
Biosimilars: adalimumab-atto (Amjevita),8 adalimumab-adbm (Cyltezo),9 adalimumab-adaz (Hyrimoz)10
Drug class: TNFi
Boxed Warning: Refer to important safety information (*ISI*) below and
- Fatal hepatosplenic T cell lymphomas (HSTCLs) have occurred post-marketing in adolescent and young adult inflammatory bowel disease (IBD) patients treated with TNFi’s.
Warnings & Precautions
- Do not start adalimumab during an active infection. If an infection develops, monitor carefully and stop adalimumab if the infection becomes serious.
- Invasive fungal infections—for patients who develop a systemic illness on adalimumab, consider empiric antifungal therapy for those at high risk who reside in, or travel to, regions where mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis, are endemic.
- The risks and benefits of treatment with TNFi’s, including adalimumab, should be considered prior to initiating therapy in patients with a known malignancy, other than a successfully treated non-melanoma skin cancer, or when considering continuing a TNF blocker in patients who develop a malignancy.
- Anaphylaxis or serious allergic reactions may occur.
- Hepatitis B virus (HBV) reactivation can occur. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop adalimumab and begin antiviral therapy.
- Demyelinating disease, exacerbation or new onset, may occur.
- Cytopenias, pancytopenia—advise patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on adalimumab. Consider discontinuation of therapy in patients with confirmed significant hematologic abnormalities.
- Heart failure, worsening or new onset, may occur.
- Lupus-like syndrome—stop adalimumab if the syndrome develops.
Dosage & Administration
