Sponsored by Janssen
Psoriatic arthritis (PsA) is a clinically heterogeneous, chronic, and progressive immune-mediated disease that develops in up to 30 percent of patients with psoriasis and is characterized by a form of inflammation, which can include both the skin and joints.1-3 Around 1.5 million people in the United States are currently living with PsA, and common delays in diagnosis and treatment can lead to worse functional outcomes.4,5 Given that active PsA presents differently in each patient in terms of disease extent, severity, and response to therapy, healthcare professionals face several diagnosis and disease management challenges.2
Here are some key considerations to keep in mind when working with patients to navigate this chronic condition and implement treatment strategies to help improve active PsA symptoms.
Embracing a Multidisciplinary Approach
“Despite the prevalence of active PsA in the U.S. and our understanding of the disease, underdiagnosis and, subsequently, undertreatment of patients remains a challenge,”6 said Dr. Soumya Chakravarty, MD, PhD, Senior Director, Strategic Lead, Rheumatology Therapeutic Area, at The Janssen Pharmaceutical Companies of Johnson & Johnson.
To help ensure early detection of active PsA, healthcare professionals in primary care and dermatology settings are encouraged to proactively screen patients with psoriasis for signs of active PsA with multiple, validated screening questionnaires currently available for use in clinical practice.2 The Classification Criteria for Psoriatic Arthritis (CASPAR criteria), which were developed to classify patients with active PsA in clinical studies, have served as a helpful tool for clinicians in confirming the diagnosis of active PsA.7 The CASPAR criteria use a point-scoring system based on symptoms, personal and family history of psoriasis, and radiographic evidence of new bone formation, highlighting the importance of the history of disease and the association between active PsA and psoriasis.7
“The CASPAR criteria can help confirm the diagnosis of active PsA after professionals in primary care and dermatology settings refer patients to a rheumatologist if they have three or more points in the CASPAR criteria categories,”7 said Dr. Chakravarty. “It is worth noting, however, that these tools do not provide complete certainty, which is why regular screenings are suggested in patients with psoriasis.”7,8
In addition to using diagnostic criteria to assess the severity of active PsA, rheumatologists and dermatologists are also building appropriate treatment plans based on outcomes for each individual patient.8 Various treatments are available to patients to address a range of symptoms such as inflammation, stiffness, and pain, including nonsteroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs), and biologics.2 Furthermore, some biologic agents have clinical evidence around improving symptoms of fatigue.9 Because of this, it is important that rheumatologists and dermatologists remain in contact throughout a patient’s journey to ensure they are responding to treatment depending on symptoms and their severity.2,8
Prioritizing Patient-Centric Treatment
Common symptoms of active PsA include joint pain, stiffness, and symptoms of dactylitis, enthesitis, and axial disease.1,3 However, there are other symptoms, such as fatigue, that may present differently from patient to patient.10,11 “Despite being a common concern for patients, fatigue is unfortunately often underestimated and misunderstood,”10,11 said Dr. Chakravarty. “And, although it can be subjective, fatigue is a medical symptom that can be a challenge for patients and interfere with daily activities, so it’s important for providers to consider it when making treatment decisions.”10,11
Many patients may feel disappointed by how the disease impacts their ability to do daily tasks or how they are responding to treatment. That is why it is important for patients and providers to have an open dialogue about what is and is not working to tailor a treatment plan to meet specific needs, which can include nonpharmacological strategies like improving nutrition and physical exercise, and seeking support groups.2,8,12 This individualized approach to care should also recognize the personal circumstances and environment of each patient to help ensure their treatment plan fits their lifestyle and can be implemented within different family, work, and cultural dynamics. And lastly, because active PsA is a progressive disease, and its severity can vary from patient to patient, it is important to help patients understand that it can take time to develop an appropriate treatment plan, and recognize it is not a failure if adjustments need to be made over time.8
Evaluating Biologic Therapy as a Potential Treatment Option
The introduction and continued development of biologic therapies as a treatment option represents an important development for healthcare professionals treating active PsA and has helped generate improvement in disease symptoms.13
“With differences in disease extent, severity and treatment response from patient to patient, it’s important that healthcare providers have access to biologic therapies that can help reduce the burden of active psoriatic arthritis,”8,13 said Dr. Chakravarty. “Biologics target specific cells in the immunologic pathway of inflammation to help improve symptoms that impact daily living, like joint pain, stiffness, and swelling that make everyday tasks harder to do.”13,14
As the treatment landscape for active PsA continues to evolve and patients remain in need of additional therapeutic options, rheumatologists should evaluate each patient’s active PsA individually and consider whether starting a biologic therapy at an early stage in their journey would be appropriate.8,13,15,16 One biologic therapy that is available today is TREMFYA® (guselkumab), a prescription medicine used to treat adults with active PsA.9 It is the first and only FDA-approved, fully human selective anti-IL-23 therapy for adults with active PsA.17
Two pivotal phase 3 multicenter, randomized, double-blind, placebo-controlled studies, DISCOVER 1 and DISCOVER 2, evaluated the efficacy and safety of TREMFYA® administered as 100 mg subcutaneous injections in adults with active PsA who had an inadequate response to standard therapies, including NSAIDs and DMARDs; patients in the DISCOVER 1 trial may have been previously treated with up to two anti-tumor necrosis factor alpha (TNFα) inhibitors, a biologic therapy, while patients in the DISCOVER 2 trial were biologic treatment naïve.14,18 Click here to view study designs.
The results showed that a significant percentage of patients treated with TREMFYA® reached the studies’ primary endpoint of ACR20a at 24 weeks (52% and 64%), compared to patients treated with placebo (22% and 33%) in DISCOVER 1 and DISCOVER 2, respectively.14,18
In addition, treatment with TREMFYA® resulted in an improvement in the skin manifestations of psoriasisin patients with active PsA, an improvement in dactylitis and enthesitis, and an improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F).9,b
In the 24-week, placebo-controlled period of the combined DISCOVER 1 and DISCOVER 2 clinical trials, the overall safety profile observed in patients with active PsA treated with TREMFYA® was generally consistent with the profile in patients with plaque psoriasis with the addition of bronchitis and neutrophil count decreased.9 In the 24-week, placebo-controlled period, combined across the 2 studies:
Bronchitis occurred in 1.6% of patients in the TREMFYA® q8w group and 1.1% of patients in the placebo group
Neutrophil count decreased occurred in 0.3% of patients in the TREMFYA® q8w group compared to 0% of patients in the placebo group. The majority of events of neutrophil count decreased were mild, transient, not associated with infection and did not lead to discontinuation
Results may vary. TREMFYA® is not right for everyone. Click here for more information to help determine if TREMFYA® may be right for your adult patients with active PsA.
Selected Important Safety Information
TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported. TREMFYA® may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a clinically important or serious infection develops, discontinue TREMFYA® until the infection resolves. Evaluate for tuberculosis before treating with TREMFYA®. Avoid use of live vaccines in patients treated with TREMFYA®. Please see related and other Important Safety Information below.
Continuing Patient Support Along the Treatment Journey
Support programs can be an important resource for both patients and healthcare providers to help ease some of the challenges patients face when starting and staying on treatment. For example, if a patient has been prescribed TREMFYA® for approved on-label use and is 18 or older, they are eligible for the TREMFYA withMe program.* TREMFYA withMe provides a range of dedicated support to help make it easier for patients as they begin, and continue, their TREMFYA® treatment journey. At the core of the program is a TREMFYA withMe Guide, a dedicated and qualified healthcare professional† who can work one-on-one with patients to answer questions about prescription fulfillment and cost support, connect patients to injection support, help with treatment expectations, and provide regular updates and reminders at the patient’s request.
Click here to learn more about TREMFYA withMe.
TREMFYA withMe is limited to education for patients about TREMFYA®, its administration, and/or their disease, and is not intended to provide medical advice, replace a treatment plan from the patient’s doctor or nurse, or provide case management services.
*For those eligible, TREMFYA withMe is completely free. Eligibility for program components may vary.
†Guides do not provide medical advice.
IMPORTANT SAFETY INFORMATION
TREMFYA® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA®. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA® and initiate appropriate therapy
TREMFYA® may increase the risk of infection. Treatment with TREMFYA® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.
Consider the risks and benefits of treatment prior to prescribing TREMFYA® in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving TREMFYA® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue TREMFYA® until the infection resolves.
Pre-Treatment Evaluation for Tuberculosis (TB)
Evaluate patients for TB infection prior to initiating treatment with TREMFYA®. Initiate treatment of latent TB prior to administering TREMFYA®. Monitor patients for signs and symptoms of active TB during and after TREMFYA® treatment. Do not administer TREMFYA® to patients with active TB infection.
Prior to initiating TREMFYA®, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA®.
Most common (≥1%) adverse reactions associated with TREMFYA® include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.
The overall safety profile observed in patients with psoriatic arthritis is generally consistent with the safety profile in patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decreased.
TREMFYA® is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
TREMFYA® is indicated for the treatment of adults with active psoriatic arthritis.
DISCOVER-1 and DISCOVER-2 Study Designs
DISCOVER-1 and DISCOVER-2 were two phase 3, multicenter, randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of TREMFYA® administered q8w subcutaneously after starter doses at Week 0 and Week 4 (n=127 and n=248, respectively) or placebo (n=126 and n=246, respectively), with starter doses at Week 0 and then every 4 weeks in patients with active PsA (fulfilling ClASsification criteria for Psoriatic ARthritis [CASPAR]) despite standard therapies (nonbiologic DMARDs, apremilast, and NSAIDs. A stable dose of 1 selected nonbiologic DMARD, corticosteroids, and NSAIDs was permitted but not required. In DISCOVER-1, eligible patients (≥18 years of age) had active PsA (swollen/tender joints ≥3, C-reactive protein [CRP] ≥0.3 mg/dL) for at least 6 months and included patients with prior biologic experience of ≤2 anti-TNFα treatments. Patients with other inflammatory diseases and those who had previously received Janus kinase (JAK) inhibitors or biologics other than TNFα inhibitors were excluded. In DISCOVER-2, eligible patients (≥18 years of age) had active PsA (swollen/tender joints ≥5, CRP ≥0.6 mg/dL) for at least 6 months and no prior JAK inhibitor or biologic experience. At Week 16, patients in all treatment groups who had <5% improvement from baseline in both swollen and tender joint counts were considered as meeting early escape and were allowed to initiate or increase the dose of one of the permitted concomitant medications up to the maximum dose allowed. The primary endpoint in DISCOVER-1 and DISCOVER-2 was ACR20 response at Week 24.14, 18, 20
© Janssen Biotech, Inc. 2022 11/22 cp-343015v1