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Q: With Psoriasis Awareness Month coming up in August, what resources can I provide to my patients to help them learn more about their condition?
A: The National Psoriasis Foundation (NPF) website (www.psoriasis.org), which sponsors Psoriasis Awareness Month, is an excellent resource to which you can refer your patients. The NPF provides patients with the help needed to best manage their psoriasis or psoriatic arthritis (PsA) while promoting research to find a cure. They offer several programs and services for patients. In navigating through the site, patients can learn about the different types of psoriasis, available treatment options, and the rights they have to healthcare and view answers to frequently asked questions. There is also information on how they can get involved with volunteer work and how to find a doctor, as well as tips for navigating the healthcare system. Further, through this site, patients are given the opportunity to connect with others who are also suffering from these conditions via message boards, networks, mentoring programs, etc.
Q: What are some of the investigational agents being studied for use in PsA?
A: Investigational agents with promising efficacy and safety data in PsA include brodalumab (anti-interleukin [IL]-17),1 clazakizumab (anti-IL-6),2 secukinumab (anti-IL-17),3 and ixekizumab (anti-IL-17).4 Numerous other novel agents are in early phase trials.
Brodalumab was studied in a phase 2, randomized, double-blind, placebo-controlled trial in patients with PsA. Study results showed that treatment with brodalumab significantly improved signs and clinical symptoms associated with PsA, including tender and swollen joints, at 12 weeks as measured by an American College of Rheumatology 20% response (ACR20). Patients were randomized to receive subcutaneous brodalumab 140 mg, brodalumab 280 mg, or placebo at day 1 and weeks 1, 2, 4, 6, 8, and 10. At week 12, patients were offered open-label brodalumab (280 mg) every 2 weeks. At week twelve, 37% of patients treated with brodalumab 140 mg and 39% of those treated with brodalumab 280 mg achieved an ACR20 response compared with 18% of placebo-treated patients (P=0.03 and P=0.02, respectively). At week 24, ACR20 response rates in the brodalumab 140-mg and 280-mg groups were 51% and 64%, respectively, vs 44% among patients who were switched from placebo to open-label brodalumab; responses were sustained through week 52. The most commonly reported adverse events (AEs) were upper respiratory tract infection, fatigue, diarrhea, and headache. The authors concluded that larger studies of longer duration are needed to further assess AEs.1
In a small pilot study, clazakizumab was shown to be effective in controlling arthritis, enthesitis, and dactylitis in PsA patients compared with placebo. The study included 165 patients with PsA who had an inadequate response to NSAIDs and/or disease-modifying antirheumatic drugs (DMARDs). Patients were randomized to clazakizumab 25 mg, 100 mg, or 200 mg once a month subcutaneously or to placebo, with or without methotrexate, for 24 weeks. The primary endpoint, ACR20, was achieved in 52.4% of patients taking clazakizumab 100 mg at week 16 compared with placebo (29.3%; P=0.039) and 46.3% (P=0.101) and 39% (P=0.178) of patients taking the 25-mg and 200-mg doses, respectively. There were also decreases in enthesitis scores and dactylitis digits by week 16. Clazakizumab had a tolerable safety profile consistent with IL-6 blockade.2
Secukinumab is currently US Food and Drug Administration (FDA)-approved for the treatment of moderate to severe plaque psoriasis and is being studied for use in PsA. In the phase 3, randomized, placebo-controlled FUTURE 2 study, subcutaneous secukinumab 300 mg and 150 mg were shown to be efficacious over 1 year in 64% of PsA patients, as measured by ACR20. The study included 397 patients with active PsA and compared secukinumab 300 mg, 150 mg, and 75 mg to placebo. At week 24, the study met its primary endpoint of ACR20, with response rates significantly higher in the secukinumab 300 mg (54%; P<0.0001) and 150 mg (51%; P<0.0001) groups vs placebo (15%). Secukinumab was well tolerated; most common AEs observed were respiratory tract infections and nasopharyngitis.3
Ixekizumab was evaluated in a 24-week, phase 3 study (SPIRIT-P1), and results showed that it was statistically superior to placebo in the treatment of patients with active PsA, demonstrated by ACR20 responses. Patients naïve to biologic DMARDs were treated with 1 of 2 dosing regimens or placebo. In both dosing regimens, ixekizumab-treated patients demonstrated significant improvements vs placebo in signs and symptoms of active PsA.4
Q: I sometimes struggle with the diagnosis of patients with PsA. What is the best method or guidelines to follow when diagnosing such patients?
A: Several classification criteria have been proposed for the diagnosis of PsA, but the most widely used and highly specific classification system for diagnosing PsA is known as the Classification Criteria for Psoriatic Arthritis (CASPAR). CASPAR permits the diagnosis of PsA in spite of low rheumatoid factor (RF) positivity. It offers classification criteria that are simple and easy to use with a high degree of specificity and good sensitivity. In fact, the latest CASPAR classification allows people to be classified easier and earlier; thereby, patients can be prescribed treatment earlier in the disease process, resulting in better patient outcomes.
According to CASPAR, a patient must have inflammatory articular disease (joint, spine, or entheseal) and ≥3 points from the following categories: (1) the presence of psoriasis (current, history of, or family history of), (2) psoriatic nail dystrophy, (3) a negative RF test result, (4) dactylitis (history of or current), and (5) radiographic evidence of juxta-articular new bone formation.
Other PsA classification systems have been or are being developed, including the Composite Psoriatic Disease Activity Index and the Minimal Disease Activity (MDA) criteria.
Q: I have a patient who is complaining of joint pain, primarily in both hands. She also presents with dactylitis and tenosynovitis, and is negative for rheumatoid factor (RF). While it appears that she may have psoriatic arthritis (PsA), she has no clinical signs of psoriasis—no skin or nail lesions. Can a diagnosis of PsA be considered without evidence or history of psoriatic lesions?
A: Based on the CASPAR classification criteria for diagnosing PsA, psoriasis is one of the key criteria needed for diagnosis; however, it can be current psoriasis, history of psoriasis, or family history. Since your patient does not currently have psoriasis or a history, the key fact you will want to find out here is whether your patient has a family history of psoriasis, as this will count toward your diagnosis. If so, the family history combined with the dactylitis and a negative RF test as well as asymmetric joint pain can help you proceed with a PsA diagnosis.
Q: Can psoriatic nail involvement be predictive of psoriatic arthritis (PsA)?
A: Many patients with psoriasis have psoriatic nail pitting, onycholysis, and hyperkeratosis, but do not have PsA. However, nail dystrophy can be a clinically relevant marker and should raise suspicion for psoriatic joint disease.5 In 1 cohort study with 1593 psoriasis patients, nail dystrophy was found to be a significant predictor of co-existing PsA.5 Keep in mind that the nail involvement can also help differentiate PsA from rheumatoid arthritis (RA), as nail dystrophy does not occur in RA.
Q: Can a patient with PsA present with normal erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels?
A: Yes! Measuring ESR and CRP has limited clinical utility to actually diagnose PsA because these markers have been shown to be elevated in only half of patients with PsA.5 However, it can still be worthwhile to measure these markers for patients suspected to have PsA because these measurements can be useful to assess disease activity for those PsA patients found to have elevated ESR and CRP.
Q: If a patient with psoriasis develops joint pain, does that mean they have PsA?
A: Not necessarily! Not all joint pain in patients with psoriasis is PsA. Many patients with psoriasis develop joint pain, and it may be due to other conditions, such as osteoarthritis or degenerative joint disease. PsA is a true inflammatory arthritis with well-defined characteristics, as has been discussed in the activities within this Learning Center.
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