RHEUMATOID ARTHRITIS

Clinical Features, Diagnosis, and Disease Course

Clinical Features

RA is a chronic autoimmune inflammatory disease that predominantly affects the joints. However, given its systemic nature, it may also cause fever, weight loss, marked fatigue, and muscle atrophy (Wasserman, 2011) as well as other organ-specific features, including scleritis, accelerated cardiovascular disease, and interstitial lung disease (NICE, 2018). The lifetime risk of RA is two to three times higher among women than among men (Crowson et al., 2011). The onset of RA peaks between the ages of 30 and 50 years, although it may occur at any age (Tehlirian and Bathon, 2008). Risk factors include older age, a family history of RA, and current or prior cigarette smoking (Costenbader et al., 2006). Mortality in RA is 1.5–2-fold higher than in age- and gender-matched non-RA controls (Liao, 2017) predominantly due to accelerated cardiovascular disease and interstitial lung disease.

The arthritis of RA, as with any inflammatory arthritis, typically presents with joint pain and swelling as well as prolonged stiffness in the early morning. Early RA may present in a single joint (monoarthritis) or in a few joints (oligoarthritis) but characteristically tends to evolve into a symmetrical polyarthritis of small and large joints which, if left untreated or inadequately treated, will cause damage to articular structures and disability. RA-associated interstitial lung disease may cause severe respiratory impairment leading to the need for transplant or death, although the musculoskeletal impairments associated with RA are more commonly the most disabling and the major source of functional limitations for individuals with this condition. This section focuses on those impairments, although the committee acknowledges that RA may also influence global functioning through other mechanisms such as fatigue (Filipovic et al., 2011). The common pathophysiology underlying musculoskeletal impairments in RA is inflammation of the synovium (Scott et al., 2010).

Clinical Diagnosis and Professionally Accepted Classification Criteria for Rheumatoid Arthritis

The diagnosis of RA is based on a patient’s clinical history, physical examination, and laboratory findings. Although there are no validated or universally accepted diagnostic criteria for RA, the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA inform generally accepted diagnostic criteria for the condition. It is important to remember that these classification criteria were developed for research studies to allow for the identification of individuals with early-stage RA and were not intended for clinical practice. The criteria are outlined in Table 6-1 and are intended to be applied to individuals for whom there is clinical suspicion of RA based on definite synovitis in at least one joint, as determined by physical exam, that is not better explained by a different condition.

TABLE 6-1

Classification Criteria for Rheumatoid Arthritis.

Patients with a score of at least 6 out of 10 are considered to have “definite RA.” The 2010 ACR/EULAR criteria were designed to identify patients with recent-onset and active RA; however, adults with longstanding or inactive disease also may be diagnosed with RA if there is documentation indicating that they have previously fulfilled those criteria. Adults with inflammatory arthritis but who lack both rheumatoid factor and anti-citrullinated protein antibody on laboratory testing might not satisfy the 2010 ACR/EULAR criteria (Humphreys and Symmons, 2013), but may still be diagnosed with (seronegative) RA if their clinical findings are otherwise characteristic of the disease and if alternative diagnoses are excluded. In those cases, radiographic findings of bone erosions, which are characteristic of RA, may help support the diagnosis, although radiography is generally not required to establish a diagnosis (Scott et al., 2010).

Disease Course, Outcomes, and Variability

While patients with RA exhibit considerable heterogeneity in terms of their disease course, the severity of the disease, and their response to various therapies, it is clear that untreated RA inexorably leads to progressive joint damage and disability, sarcopenia, weight loss, and premature mortality. This trajectory is largely preventable with early and aggressive treatment with the goal of achieving and sustaining a state of disease remission or at least of low disease activity throughout the course of the disease.

ACR and EULAR guidelines for the treatment of RA advise measurement of disease activity every 2 to 4 months and adjustment of the therapy if there is neither remission nor low disease activity (Fraenkel et al., 2021; Smolen et al., 2020). These outcomes (remission and low disease activity) are defined for each specific disease activity measure, and the clinician can determine whether the patient is at goal at the time of the visit.

The principal outcome measures used to assess response to treatment for RA are composite, multidimensional outcome measures that use the same elements that make up the disease activity scores. These include clinical data (i.e., the physical examination, laboratory markers such as erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP], and a physician’s assessment), functional assessment, patient-reported symptoms, and patient-reported global assessment (Felson and LaValley, 2014). Because of the heterogeneity of RA and its impact on multiple organ systems, improvement cannot be accurately determined based on a single domain (e.g., laboratory markers); accordingly, the use of composite outcome measures reflecting multiple disease domains has become the norm (Aletaha et al., 2008). Notably and of key importance, the routine assessment of physical functioning is strongly recommended as part of any treatment strategy for RA, and reduced physical functioning is more widespread in RA than in many less painful but equally disabling medical conditions (Singh et al., 2016). We review the major measures used to assess treatment response below, noting that while these measures are widely used in research and clinical trials, their application in routine clinical practice by U.S. rheumatologists is highly variable (Anderson et al., 2011).

For patients with RA, the ACR has developed several definitions of a response to therapy, including the ACR20, the ACR50, and the ACR70, which indicate an improvement of at least 20 percent, 50 percent, or 70 percent, respectively, on a set of core outcome measures (Felson and LaValley, 2014). These core measures include the swollen joint count, the tender joint count, and three out of the following five measures: pain visual analog scale (patient-reported pain symptom scale), patient global assessment, physician global assessment, inflammatory marker levels (either ESR or CRP), and a measure of physical functioning (commonly the Health Assessment Questionnaire [HAQ] Disability Index or one of the newer modifications of the HAQ, described above). Of these, the ACR20 is the most widely used, and it has been recommended by the U.S. Food and Drug Administration (FDA) as a preferred outcome measure in studies of new drugs for RA; accordingly it has been commonly used as the primary outcome in clinical trials of RA therapies (Aletaha et al., 2008; Felson and LaValley, 2014) although more stringent outcomes (ACR50 or ACR70) have been increasingly used in the last decade.

However, the ACR 20/50/70 responses are not recommended for monitoring treatment response in clinical practice. Rather, an assessment and calculation of the level of disease activity at each visit is strongly recommended, using one or more of the above scales, as these are more feasible to implement in clinical settings (Greenberg et al., 2009). There are defined ranges for high, moderate, and low disease activity levels as well as for remission for the commonly used measures of disease activity (DAS28,¹ the Clinical Disease Activity Index, the Simple Disease Activity Index). The goal in clinical practice is the achievement of remission. However, remission is not feasible or attainable in some patients with RA; in this case the goal should be attainment of low disease activity. Examples of patients in whom remission may not be attainable include but are not limited to: (1) those who have failed multiple other RA therapies and have few options left, (2) those whose disease activity is driven largely by pain while all other measures of disease activity suggest remission, (3) comorbid illnesses and associated therapies that limit safe options for tight control of the RA.

There are no professionally accepted definitions of “severe” RA, and the severity of the disease is generally determined at a particular point in time by the validated measures of disease activity, including those described above, while cumulative severity is generally reflected by a measure of function or by assessment of articular damage demonstrated on radiographs, or both. Specifically, ACR-endorsed instruments to measure RA disease activity and to define remission include: DAS and its variants such as DAS28-CRP and DAS28-ESR, the Clinical Disease Activity Index (CDAI) and the Simplified Disease Activity Index (SDAI), the Patient Activity Scale (PAS), the PASII, and the Routine Assessment of Patient Index Data 3 (RAPID-3), (Johnson et al., 2020). All scales are multidimensional, composite measures and most draw on data from several different domains (e.g., physical exam, laboratory markers, functional measures, pain symptoms, physician- and patient-reported global assessments), although some are completely based on patient self-report (e.g., PAS). All are sensitive in discriminating between different levels of disease activity (Johnson et al., 2020). These measures are commonly reported as secondary outcomes in clinical trials of drugs for RA, and they are recommended for routine assessments in clinical practice (Anderson et al., 2011; Greenberg et al., 2009).

Disease activity scores correlate closely with the concurrent degree of functional impairment related to RA, and, indeed, several of the aforementioned scores are based in part on functional assessments (Carvalho et al., 2019). However, because RA causes cumulative joint damage and deformity, functional impairment is possible among individuals whose disease is quiescent if there has been significant previous damage (Ishida et al., 2018; Norton et al., 2014).

RA-associated damage to the joints is reflected on plain radiographs by new or worsening erosions in articular bone or by new or worsening joint space narrowing, which is an indirect reflection of cartilage erosion. Generally, hand and foot radiographs are used for this purpose, as they provide a multitude of joints for examination. Erosions and joint space narrowing reflect damage rather than disease activity, and thus they do not correlate tightly with symptoms. Radiographic damage may or may not correlate with functional scores/measures, depending on the extent and severity of damage. For example, severe damage in a single knee or ankle may be far more disabling than extensive joint damage in the hands because of the weight-bearing nature of the lower extremity joints.

Although RA is a chronic disease with daily discomfort, patients also frequently experience disease flares. During disease flares, worsening inflammation results in an exacerbation of joint pain and swelling and the potential for new joint damage. In patients with longstanding and severe disease, persistent synovial inflammation will result in the erosion of cartilage and bone, leading to joint destruction and deformities, which in turn cause chronic pain and functional limitations (Sokka and Pincus, 2001).

Treatment and Management of Rheumatoid Arthritis

The goal of RA treatment is to attain and maintain control of disease activity in an effort to reduce the symptoms of joint pain and swelling, prevent deformity, maintain quality of life and function, and limit extra-articular disease manifestations (Wasserman, 2011). Pharmacologic treatments, specifically disease-modifying anti-rheumatic drugs (DMARDs), are the mainstay of therapy (Singh et al., 2016) as they limit progressive joint damage and improve function (Scott et al., 2010). DMARDs are typically prescribed under the supervision of a rheumatologist. Care by a rheumatologist is associated with an earlier initiation of DMARD therapy (Rat and Boissier, 2004; Widdifield et al., 2011) and improved treatment response (Criswell et al., 1997), resulting in less joint destruction (van der Linden et al., 2010), less functional impairment (Ward, 1997), and a lower likelihood of requiring orthopedic surgery (Feldman et al., 2013). Table 6-2 summarizes the types of medications used to treat RA as well as some examples of drugs in each category. All of the targeted biologic medications can be administered subcutaneously by the patient at home, except infliximab and rituximab, which require intravenous infusion.

TABLE 6-2

Medications Used to Treat Rheumatoid Arthritis.

Evidence-based treatment guidelines for the pharmacologic management of RA include the 2021 ACR guidelines and the 2019 EULAR guidelines (Smolen et al., 2020). Both the ACR and EULAR guidelines primarily focus on the pharmacologic management of RA. Patients who are not in clinical remission and who have any degree of disease activity as measured using validated scales are considered candidates for therapy; indeed, it is recommended that therapy for RA be initiated as soon as possible after the diagnosis is established, as there is evidence that earlier DMARD therapy is associated with better outcomes. The specific agents recommended are determined by the degree of disease activity, the prior treatments used, the treatment response and toxicities, and the patients’ comorbidities (Anderson et al., 2000; Nell et al., 2004; Smolen et al., 2016). The goal of therapy is sustained clinical remission or low disease activity (Ramiro et al., 2014).

Under the 2021 ACR guidelines, monotherapy with methotrexate is recommended as the first-line initial treatment for RA patients with moderate to high disease activity, and hydroxychloroquine is recommended for those with low disease activity. For patients who do not improve sufficiently with methotrexate monotherapy (i.e., the RA disease activity remains moderate to high), the addition of a biologic DMARD or a targeted synthetic DMARD is recommended in preference to a combination of conventional DMARDs. If treatment targets are not achieved with combination therapy, it is recommended that the biologic or targeted synthetic DMARD be switched to an agent with a different class (mechanism) rather than to a second agent within the same class. Glucocorticoid treatment is discouraged for the treatment of RA at any point in the course of RA due to toxicity concerns; however, if its use is believed to be necessary, it should be given at the lowest effective dose for the shortest duration possible. Once remission or low disease activity is achieved on a specific DMARD regimen, continuation of that regimen is recommended because discontinuation of DMARDs is associated with a high risk of relapse and the need to resume DMARD therapy. For patients in remission or who have experienced low disease activity for at least 6 months, the gradual tapering of one of the DMARD therapies can be considered, but maintenance of at least one DMARD is recommended. Again, the guidelines recommend against discontinuing all therapy due to the risk of relapse.

The 2019 EULAR recommendations for RA treatment are largely similar to the 2021 ACR guidelines: notably, conventional DMARDs (and specifically methotrexate) are recommended as the initial therapy for RA; the addition of, or switch to, an alternate DMARD is recommended if improvement is not achieved, and if patients do not respond to a biologic DMARD, the guidelines recommend switching to a different biologic DMARD or tofacitinib. There are, however, several distinctions between the ACR and EULAR guidelines worth noting. First, the EULAR guidelines recommend that short-term glucocorticoid therapy be considered when initiating or changing DMARDs, whereas the ACR guidelines caution against any use of glucocorticoids if possible. Second, for patients who do not respond to an initial monotherapy with a conventional DMARD, the EULAR guidelines recommend that the choice of the subsequent agent be based on prognostic factors; specifically, for patients with “unfavorable” prognostic indicators (i.e., the presence of autoantibodies especially at high levels, high disease activity, early erosions, or no response to two traditional DMARDs), a biologic DMARD or janus kinase (JAK)-inhibitor is recommended. For patients in whom such findings are absent, the guidelines recommend adding or changing to a different conventional DMARD. In contrast, the ACR guidelines do not discuss the role of prognostic factors in treatment selection.

The ACR and EULAR guidelines are based on comprehensive and systematic reviews of the evidence on RA treatment; however, they have several limitations in the context of this document. First, the guidelines do not discuss non-pharmacologic treatments for RA or the optimal combination of pharmacologic and non-pharmacologic therapies. Randomized controlled trials support the use of physical exercise as a strategy to improve muscle strength and quality of life (Baillet et al., 2009; Brodin et al., 2008), whereas complementary therapies such as acupuncture and dietary changes have not been found to provide benefit (Hagen et al., 2009; Kelley et al., 2009; Smedslund et al., 2010; Wang et al., 2008). Second, neither guideline explicitly discusses the impact of DMARDs on work-related functional capacity (Nam et al., 2017), which is the outcome of principal interest to the committee because it is especially relevant to the Social Security Administration (SSA) disability population. Many of the individual studies on which the guidelines are based do assess the impact of DMARDs on measures of physical functioning, but there are limitations in extrapolating from those scales in order to estimate impacts on actual work capacity.

Beyond the ACR and EULAR guidelines, an important limitation of the RA treatment literature more broadly is the limited evidence that is available to guide the management of patients with refractory RA (Singh et al., 2016). While there is no universally accepted definition of refractory RA, the term is often used to refer to patients who have not responded to at least two different targeted DMARDs or to two different targeted biologic DMARDs with different mechanisms of action (Buch, 2018; de Hair et al., 2018; Kearsley-Fleet et al., 2018; Roodenrijs et al., 2018). The prevalence of refractory RA is not well established; the only published national registry study to date is from the United Kingdom, and it estimated that at least 6 percent of patients with RA have been exposed to at least three DMARDs, which is suggestive of difficult-to-treat disease (Kearsley-Fleet et al., 2018). It is not known what share of SSA beneficiaries with RA satisfy this definition of refractory disease, but because those patients have a lower chance of clinical remission, it is likely that they are disproportionately represented in the SSA population. At present, there is limited evidence to inform the appropriate treatment strategy for patients with refractory RA. Baracitinib was efficacious in a study population in which the majority of patients had refractory disease (i.e., had previously tried at least two different biologic DMARDs without success), so it may provide an alternative for those patients (Genovese et al., 2016). Other novel therapies are currently under investigation (Aletaha and Smolen, 2018; Cheung and McInnes, 2017).

Likelihood of Improvement Given Treatment

Nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose glucocorticoids can provide symptom relief within days. With DMARDs, clinical improvement is typically expected within 1–3 months of starting therapy, although a substantial number of patients might not achieve full response until months 3–6 (Kavanaugh, 2010; Kavanaugh et al., 2008). Accordingly, many clinical trials of RA therapeutics now assess treatment response at both 3 and 6 months, and the EULAR treatment guidelines for RA recommend changing therapy if no improvement is seen after 3–6 months (Ramiro et al., 2014).

The likelihood of improvement depends on the severity of the disease. A EULAR task force (Smolen et al., 2020) suggests the following factors as predictive of poor prognosis:

• Persistently moderate or high disease activity despite conventional synthetic DMARD therapy according to composite measures including joint counts
• Failure of two or more conventional DMARDs
• High acute-phase reactant levels
• High swollen joint count
• Presence of a rheumatoid factor (RF) and/or anti-citrullinated protein antibody (ACPA), especially at high levels
• Presence of early erosions

The task force notes that there is no evidence for differential response that can be attributed solely to disease duration. However, disease duration can be associated with more radiographic damage, especially if the initiation of disease modifying therapy is delayed (Smolen et al., 2020).

Secondary Impairments from Treatment

While pharmacologic treatments for RA can substantially improve symptoms, they also have associated toxicities that are important to consider (Aletaha and Smolen, 2018; Graham, 2006; Harirforoosh et al., 2013; Huscher et al., 2009; Kamata and Tada, 2020; Nash et al., 2013; Rindfleisch and Muller, 2005; Saag and Cowdery, 1994; Sostres et al., 2010). Serious infections are among the most concerning potential adverse effects of biologic DMARDs and glucocorticoids because of their immunosuppressive properties. The toxicities of medications may limit their use in specific patients depending on comorbidities (particularly patients with liver, renal, or cardiovascular disease) and may prompt patients to discontinue or switch medications (Choquette et al., 2019).

Table 6-3 provides a summary of the toxicities of RA therapies, which also apply to PsA.

TABLE 6-3

Toxicities of Therapies for Rheumatoid Arthritis and Psoriatic Arthritis.

Select Treatments Currently in Clinical Trials

Clinical trials are currently in progress for novel therapeutic interventions for inflammatory arthritis. A search on the ClinicalTrials.gov website for actively recruiting clinical studies in RA and PsA was performed, yielding 376 and 33 listings, respectively. Given the large number of ongoing clinical trials for drugs that treat inflammatory arthritis, the list was further restricted to multicenter, multinational, double-blind randomized trials of novel agents not currently FDA-approved. The final list is shown below in Table 6-4.

TABLE 6-4

Novel Agents in Clinical Trials for Rheumatoid Arthritis and Psoriatic Arthritis.

PSORIATIC ARTHRITIS

Clinical Features, Diagnosis, and Disease Course

Clinical Features

PsA is a chronic inflammatory disease of the joints, spine, and entheses. It may affect other tissues as well (e.g., dactylitis, nail involvement, sacroiliitis, enthesitis) and most commonly occurs in association with psoriasis, an autoimmune skin disease manifested by erythematous plaques covered by silvery scales (Coates and Helliwell, 2017). Skin manifestations commonly precede the arthritis; however, in some patients the skin and joint symptoms present simultaneously, and in 10–15 percent of patients the arthritis presents first. PsA is a heterogeneous condition with five recognized subtypes, though it is increasingly acknowledged that patients may have any combination of these features (Moll and Wright, 1973; Ogdie and Weiss, 2015): (1) mono- or oligo-arthritis (involving up to four joints, typically asymmetric); (2) polyarthritis (involving five or more joints, typically symmetric); (3) distal-interphalangeal-joint predominant disease; (4) psoriatic spondylitis/sacroiliitis; and (5) arthritis mutilans. Peripheral oligoarticular or polyarticular disease is most common; arthritis mutilans, which is the most severe and deforming disease manifestation, is rare (Haddad and Chandran, 2013).

Clinical Diagnosis and Professionally Accepted Classification Criteria for Psoriatic Arthritis

The diagnosis of PsA is based on the clinical history, a physical examination, laboratory findings, and radiography. The most widely used classification criteria for PsA are the Classification of Psoriatic Arthritis criteria (Taylor et al., 2006), which are highly sensitive and specific across varied clinical settings (Chandran et al., 2008; D’Angelo et al., 2009; Leung et al., 2010; van den Berg et al., 2012). The criteria, which are outlined in Table 6-5, are intended to be applied to individuals for whom there is a clinical suspicion of PsA based on inflammatory disease of the joints, spine, or entheses. Patients with a score of at least 3 points are considered to have PsA. Laboratory markers are less helpful in affirmatively establishing the diagnosis of PsA than they are in excluding other inflammatory arthropathies (Gladman et al., 1987).

TABLE 6-5

Classification Criteria for Psoriatic Arthritis.

PsA affects men and women equally (Brockbank and Gladman, 2002). The average age at diagnosis is typically between 40 and 50 (Kerschbaumer et al., 2016). Obesity has been identified as a risk factor for the development of PsA (Kerschbaumer et al., 2016; Ogdie and Weiss, 2015).

Disease Course, Outcomes, and Variability

As with RA, PsA has heterogeneous clinical manifestations so that improvement cannot be accurately determined by considering only unidimensional measures, such as laboratory markers. The principal measures used to assess response to treatment and remission for PsA are currently the same as those used for RA, and they represent composite, multidimensional outcome measures incorporating clinical data, functional assessment, patient-reported symptoms, and global assessment (Felson and LaValley, 2014). We review the major measures used to assess treatment response below, noting that these measures were primarily developed for research and clinical trials and hence their application in routine clinical practice by U.S. rheumatologists is unclear. More specific outcome and disease activity measures for PsA are currently under development by the Group for Research and Assessment in Psoriasis and Psoriatic Arthritis (GRAPPA) and the Outcome Measures in Rheumatology groups.

The ACR20, developed for RA and described above, is also frequently used in clinical trials of medications for PsA. Other treatment response criteria developed specifically for PsA include the Psoriatic Arthritis Response Criteria (PsARC) and the Minimal Disease Activity (MDA) criteria. The PsARC defines treatment response as achieving two of the following: tender and swollen joint count improvement by at least 30 percent (Mease et al., 2005), patient global improvement by one point on a five-point Likert scale, or physician global improvement by the same amount. The MDA criteria are achieved when low scores are obtained in five of the following seven domains: tender joint count, swollen joint count, body surface area affected by psoriasis, pain symptoms, patient-reported global disease activity, Health Assessment Questionnaire Disability Index, and tender entheseal points count (Wong et al., 2012).

RA disease activity measures such as the DAS have also been used in PsA clinical trials, though it has been noted that because of differences in the clinical presentation of RA and PsA, some of the RA-specific measures may be less accurate when applied to PsA. The DAS, for example, may not be appropriate for patients who have predominantly lower extremity or distal interphalangeal joint disease since these joints are not included as part of the standard DAS 28-joint count. Measures of disease activity that have been developed and validated specifically for PsA include the Disease Activity Index for Psoriatic Arthritis, the Psoriatic Arthritis Joint Activity Index, the Composite Psoriatic Disease Activity Index, and the Psoriatic Arthritis Disease Activity Score (Gladman, 2010; Mease et al., 2005; Ogdie et al., 2020; Schoels et al., 2016; Wong et al., 2012). All are composite measures based on data drawn from multiple domains (e.g., the physical examination, laboratory markers, pain symptoms, patient- or physician-reported global assessments, functional measures, and health-related quality of life) (Helliwell and Waxman, 2018; Wong et al., 2012).

As with RA, PsA disease activity scores correlate closely with the degree of functional impairment, and several of these scores are based in part on functional assessments. Functional impairment is still possible, however, among individuals with previously active disease that is now quiescent if accumulated joint damage and deformity have occurred (Kerschbaumer et al., 2016).

The HAQ, developed for RA and described above, is also commonly included as an outcome measure in PsA clinical trials (Mease et al., 2005; Ogdie and Weiss, 2015).

Treatment and Management of Psoriatic Arthritis

As with RA, the goals of treatment for PsA include controlling symptoms, preventing structural damage and deformity, and improving physical functioning and quality of life (Gossec et al., 2016). DMARDs are the mainstay of treatment because they are effective in limiting progressive joint damage, and they are prescribed under the supervision of a rheumatologist. As shown in Table 6-6, there is considerable overlap between the DMARDs recommended for PsA and those recommended for RA, but there are also some notable differences in the specific drug classes used. Agents that are specifically used in PsA but not RA are apremilast and inhibitors of IL-12/23, IL-23 and IL-17. Conventional DMARDs are orally administered, while the IL–12/23, IL-23, and IL–17 inhibitors are available in prefilled syringes that can be injected subcutaneously by patients at home. There may be a role for NSAIDs and glucocorticoids in short-term symptom relief. Non-pharmacologic treatment options are similar to those for RA (Singh et al., 2019). Patients with PsA commonly experience pain; adjunctive therapies targeting pain symptoms are discussed in detail in Chapter 2. The indications for surgical intervention are the same as in RA patients.

TABLE 6-6

Medications Used to Treat Psoriatic Arthritis.

Clinical Practice Guidelines for Receiving Treatments

Evidence-based treatment guidelines for the pharmacologic management of PsA include the 2018 ACR/National Psoriasis Foundation (NPF) guideline (Singh et al., 2019), the 2015 EULAR recommendations, and the 2015 GRAPPA recommendations (Coates et al., 2016; Gossec et al., 2016). Under all sets of guidelines, the goal of therapy is clinical remission or minimal to low disease activity (Gossec et al., 2016). The preferred treatment may be influenced by the disease severity, medication toxicities, and comorbidities (e.g., heart failure) and by specific PsA disease manifestations (e.g., severe skin disease, axial disease, enthesitis, uveitis [Singh et al., 2019]). Notably, the evidence base underlying the PsA treatment guidelines is more limited than that underlying the RA treatment guidelines reviewed in the previous section, and there are some notable differences between the major guidelines.

Under the 2018 ACR/NPF guideline (Singh et al., 2019), the options for the initial treatment of active PsA in descending order of preference are: a TNF inhibitor, a conventional synthetic DMARD, an IL-17 inhibitor, and an IL-12/23 inhibitor. For treatment-naïve patients with less active disease, NSAIDs may be considered. For patients who have not responded to initial therapy, regardless of the initial treatment strategy used, the subsequent treatment options in descending order of preference are: a TNF inhibitor, an IL-17 inhibitor, an IL-12/23 inhibitor, and abatacept or tofacitinib. Among patients who have not responded to therapy with a TNF inhibitor, switching to a different TNF inhibitor is preferred over using other biologic DMARDs. For patients who have not responded to a conventional DMARD and are either not candidates for biologic DMARDs or do not wish to take them, the options include adding apremilast to the current conventional DMARD or switching to a new conventional DMARD (except apremilast). Among patients with active PsA and psoriatic spondylitis/axial disease who have not responded to NSAIDs, TNF inhibitors are preferred, followed by IL-17 inhibitors. For patients with active PsA in whom enthesitis is the predominant manifestation, NSAIDs, TNF inhibitors, and tofacitinib are preferred over conventional DMARDs.

The 2019 EULAR recommendations differ somewhat from the 2018 ACR/NPF guidelines (Gossec et al., 2020). First, in the EULAR recommendations, conventional DMARDs are preferred as the first-line therapy over biologic DMARDs for PsA patients with polyarthritis or with monoarthritis/oligoarthritis and poor prognostic factors; when skin involvement is also present, methotrexate is preferred. Second, when there is an inadequate response to conventional synthetic DMARDs, a biologic DMARD is recommended; however, there is no order of preference except when there is concomitant skin involvement, in which case an IL-17 or IL-12/23 inhibitor may be preferred over other biologics. Third, in patients with inadequate responses to both a conventional and a synthetic DMARD, a JAK inhibitor may be considered. Fourth, for enthesitis or axial disease that is not responsive to conventional DMARDs, a biologic DMARD is recommended; usually this will be a TNF inhibitor, but an IL-17 may be used if there is also skin involvement. Finally, phosphodiesterase-4 inhibitors are reserved for patients with mild disease who have had an inadequate response to one or more conventional DMARDs and for whom a biologic DMARD or a JAK inhibitor is not appropriate.

The 2015 GRAPPA recommendations are similar to the 2015 EULAR recommendations for the management of peripheral arthritis, axial disease, and enthesitis (Coates et al., 2016).

The ACR/NPF, EULAR, and GRAPPA guidelines were all based on systematic reviews of the evidence on PsA treatment together with expert opinion. Similar to the RA treatment guidelines previously reviewed, one limitation of the guidelines—in the context of this study—is that they do not explicitly discuss the impact of pharmacologic treatments on work-related functional capacity, which is the outcome of principal interest to the committee. A challenge in the PsA treatment literature more broadly is the limited evidence available to guide the management of patients with PsA and, in particular, those with arthritis mutilans or other forms of severe or treatment-resistant disease who may be disproportionately represented in the SSA population (Ureyen et al., 2018). Ixekizumab, ustekinumab, and secukinumab were efficacious for patients who had inadequate responses to TNF inhibitors, so they may provide an alternative for these patients (Merola et al., 2017; Nash et al., 2017; Raychaudhuri et al., 2017; Ritchlin et al., 2014). Several other novel therapies are currently under investigation (Chiricozzi et al., 2019).

As with RA, NSAIDs and low-dose glucocorticoids can provide symptom relief within days for PsA. With DMARDs, clinical improvement is typically expected within 1–3 months of starting therapy, though some patients might not respond until months 3–6 (Schoels et al., 2018). Accordingly, as with RA, many clinical trials of PsA therapeutics assess treatment response at both 3 and 6 months, and the EULAR treatment guidelines for PsA recommend changing therapy if no improvement is seen after 3–6 months (Gossec et al., 2016).

Secondary Impairments from Treatment

The pharmacologic treatments for PsA overlap substantially with those used for RA, and therefore so do their toxicities (see Table 6-3).

Select Treatments Currently in Clinical Trials

Several novel agents are currently under investigation for PsA in randomized clinical trials, most notably Tyk-2 and IL-23 inhibitors (see Table 6-4).

JUVENILE IDIOPATHIC ARTHRITIS

JIA, formerly known as juvenile rheumatoid arthritis (JRA), is an umbrella term for several types of inflammatory arthritis in childhood. JIA excludes arthritis that is part of a larger systemic illness, such as systemic lupus erythematosus (SLE) or inflammatory bowel disease (IBD). The subtypes of JIA share the common features of joint pain and inflammation with the adult inflammatory arthropathies discussed above. By convention, JIA pertains to children less than 16 years of age, and joint inflammation needs to be present for 6 continuous weeks. JIA is the most common chronic rheumatic disease of childhood, and it affects approximately 300,000 children in the United States (Helmick et al., 2008). Typically, once an individual has been diagnosed with JIA, the diagnosis remains for the full extent of disease throughout the individual’s lifespan. Hence there are individuals of all ages that may carry the diagnosis of JIA. JIA is a heterogenous group of diseases with different features, treatments, and outcomes.

SUMMARY

Inflammatory arthritis is a broad term for a group of chronic autoimmune diseases characterized by joint pain, swelling, warmth, and tenderness in joints along with stiffness that lasts for an hour or more. Most inflammatory forms of arthritis include systemic effects such as skin rashes, eye inflammation, hair loss, and dry mouth. Unlike the more common osteoarthritis, or arthritis that is caused by physical wear and tear of a joint over time, inflammatory forms of arthritis present in children as well as adults. In 2019, inflammatory arthritis accounted for 60 percent of all Social Security disability beneficiaries who were receiving benefits for immune system disorders, not including HIV.

RA is a chronic autoimmune inflammatory disease that predominantly affects the joints. However, given its systemic nature, it may also cause fever, weight loss, marked fatigue, and muscle atrophy as well as other organ-specific features including scleritis, accelerated cardiovascular disease, and interstitial lung disease. The lifetime risk of RA is two to three times higher among women than men. The onset of RA peaks between the ages of 30 and 50 years, although it may occur at any age. Risk factors include older age, a family history of RA, and current or prior cigarette smoking. Mortality in people with RA is 1.5 to 2 times higher than in age- and gender-matched non-RA controls, a difference that is due predominantly to accelerated cardiovascular disease and interstitial lung disease.

The arthritis of RA, as with any inflammatory arthritis, typically presents with joint pain and swelling along with prolonged stiffness in the early morning. Early RA may present in a single joint (monoarthritis) or a few joints (oligoarthritis) but characteristically tends to evolve into a symmetrical polyarthritis of small and large joints which, if left untreated or inadequately treated, will cause damage to articular structures and, ultimately, disability. RA-associated interstitial lung disease may cause severe respiratory impairment leading to the need for a transplant or, sometimes, death; however, the musculoskeletal impairments associated with RA are more commonly the most disabling and the major source of functional limitations for individuals with this condition. This chapter focuses on those impairments, although the committee acknowledges that RA may also influence global functioning through other mechanisms such as fatigue. The common pathophysiology underlying musculoskeletal impairments in RA is inflammation of the synovium.

Although RA is a chronic disease with daily discomfort, patients also frequently have disease flares. During disease flares, patients experience worsening inflammation, which results in an exacerbation of joint pain and swelling and the potential for new joint damage. In patients with longstanding and severe disease, persistent synovial inflammation will result in the erosion of cartilage and bone, leading to joint destruction and deformities, which in turn cause chronic pain and functional limitations. The goal of RA treatment is to attain and maintain control of disease activity in an effort to reduce symptoms of joint pain and swelling, prevent deformity, maintain quality of life and function, and limit extra-articular disease manifestations. Pharmacologic treatments, specifically DMARDs, are the mainstay of therapy as they limit progressive joint damage and improve function.

PsA is a chronic inflammatory disease of the joints, spine, and entheses. It may affect other tissues as well (e.g., dactylitis, nail involvement, sacroiliitis, enthesitis) and most commonly occurs in association with psoriasis, an autoimmune skin disease manifested by erythematous plaques covered by silvery scales. Skin manifestations commonly precede the arthritis; however, in some patients the skin and joint symptoms present simultaneously, and in 10–15 percent of patients the arthritis presents first.

The diagnosis of PsA is based on the patient’s clinical history, a physical examination, laboratory findings, and radiography. PsA has heterogeneous clinical manifestations so that improvement cannot be accurately determined by considering only unidimensional measures, such as laboratory markers. The principal measures used to assess response to treatment and remission for PsA are currently the same as those used for RA and represent composite, multidimensional outcome measures incorporating clinical data, functional assessment, patient-reported symptoms, and global assessment. PsA affects men and women equally, with an average age at diagnosis between 40 and 50. Obesity has been identified as a risk factor for the development of PsA.

JIA, formerly known as JRA, is an umbrella term for several types of inflammatory arthritis in childhood. The subtypes of JIA share the common features of joint pain and inflammation with the adult inflammatory arthropathies. By convention, JIA pertains to children less than 16 years of age with joint inflammation present for 6 continuous weeks. JIA is the most common chronic rheumatic disease of childhood, and it affects approximately 300,000 children in the United States. Once an individual has been diagnosed with JIA, the diagnosis remains for the full extent of disease throughout the individual’s lifespan.

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