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Collaborative Care - Video Resources | Otezla® (apremilast)
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3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease. Read less

Read less

First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA SEE THE DATA

First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA

SEE THE DATA REFERENCES

No lab monitoring. No TB or baseline blood panel tests. No planning around live vaccines 1 START TODAY WITHOUT DELAY

No lab monitoring. No TB or baseline blood panel tests. No planning around live vaccines 1

START TODAY WITHOUT DELAY REFERENCES

A small pill with a big history: 840,000+ patients treated globally since 2014 1.3,* PLAQUE PSORIASIS SAFETY PsA SAFETY

A small pill with a big history: 840,000+ patients treated globally since 2014 1.3,*

PLAQUE PSORIASIS SAFETY PsA SAFETY REFERENCES & FOOTNOTE

*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=58% of data). Calculations based on observed drug utilization parameters and number of units distributed. Utilization patterns change over time to best represent current markets.

FDA, U.S. Food and Drug Administration; PsA, psoriatic arthritis; TB, tuberculosis.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Otezla® (apremilast) FDA approval letter. March 21, 2014.

OTEZLA ON DEMAND MODULES

Collaborative Care in Dermatology & Rheumatology: A Real-World Perspective

CHAPTER 1:

Case-based Insights to Recognize and Manage Psoriatic Disease

Dr. Glick (dermatologist) and Dr. Sulich (rheumatologist) discuss recognizing early signs of psoriatic arthritis in your plaque psoriasis patients, and the importance of communication between specialties for the successful comanagement of patients.

CHAPTER 2:

Pivotal Trial Data for Otezla in Plaque Psoriasis and Active Psoriatic Disease

Explore Otezla data from the ADVANCE trial in mild to moderate plaque psoriasis, the ESTEEM trials in moderate to severe plaque psoriasis, and the PALACE trials in active psoriatic arthritis.

  • VIDEO TRANSCRIPTS

    A Real-World Perspective on Collaborative Care in Dermatology & Rheumatology

    Chapter 1

    Derm: Thank you for joining us. Please see Important Safety Information during this video and the Full Prescribing Information on OtezlaPro.com.

    Derm: Hi, my name is Dr. Brad Glick, and I’m an Assistant Clinical Professor of Dermatology at the Herbert Wertheim College of Medicine at Florida International University in Miami, Florida.

    Rheum: And I’m Dr. Andrew Sulich, Assistant Clinical Professor at William Beaumont School of Medicine at Oakland University in Rochester, Michigan and Section Chief of Rheumatology at Ascension St. John Medical Center in Detroit, Michigan.

    Derm: Today, we’ll discuss the importance of collaborative care across dermatology and rheumatology in managing psoriatic disease. Specifically, how to recognize the early signs of psoriatic arthritis in patients with psoriasis and ensure continuity of care between specialties.

    Derm: To start, I’d like to discuss a real-world case of a patient who has plaque psoriasis and, I suspect, may also have joint involvement. I’d be grateful for your input on this patient, Dr. Sulich.

    Rheum:. Sure, Brad, tell me about him.

    Derm: Well, Steve was diagnosed with plaque psoriasis 10 years ago and presents with plaques on his back, elbows, shins, and scalp. He has significant itch symptoms, and examination of his nails revealed some pitting…

    Derm: Based on Steve’s affected BSA, his plaque psoriasis is mild to moderate. 1

    Steve originally used several topical steroids for his plaque psoriasis without success over the course of his treatment history.

    However, given the challenges of topicals, like how time-consuming they can be to apply, the messiness, and even poor adherence, 2,3 plus the fact that his plaques on his scalp, elbows, and shins were resistant to topicals, we decided it was time to progress to a systemic treatment.

    Rheum: Interesting. You also mentioned possible joint involvement.

    Derm: Yes, that’s why I wanted to consult with you on this case. Steve mentioned joint symptoms like knee pain, though he initially attributed this pain to his job doing manual labor. He was also recently diagnosed with plantar fasciitis by his family physician. He previously tried over-the-counter NSAIDs for his joint pain without relief.

    I probed further to see if he had any other joint pain, and he mentioned some stiffness, as well as fatigue, over the past 2 months.

    I was concerned that these symptoms could be a sign of psoriatic arthritis, especially with what we know about psoriatic arthritis and nail and scalp psoriasis. 4

    References: 1. Van Voorhees AS, Feldman SR, Lebwohl MG, Mandelin A, Ritchlin C. https://www.psoriasis.org/pocket-guide. Accessed December 9, 2021. 2. Feldman SR, Goffe B, Rice G, et al. Am Health Drug Benefits. 2016;9:504-513. 3. Alinia H, Moradi Tuchayi S, Smith JA, et al. Br J Dermatol. 2017;176:759-764. 4. Yan D, Ahn R, Leslie S, Liao W. Dermatol Ther (Heidelb). 2018;8:593-604.

    Derm: They’re both fairly common in patients with psoriatic arthritis. 1,2 Also, data suggest that nail and scalp psoriasis may be associated with a higher risk for psoriatic arthritis. 3

    Given Steve’s case presentation and the association between his symptoms and psoriatic arthritis, would you suggest referring him to a rheumatologist or waiting it out to see how the joint involvement progresses?

    References: 1. Yang Q, Qu L, Tian H, et al. J Eur Acad Dermatol Venereol. 2011;25:1409-1414. 2. Spelman L, Su JC, Fernandez-Peñas P, et al. J Eur Acad Dermatol Venereol. 2015;29:2184-2191. 3. Wilson FC, Icen M, Crowson CS, McEvoy MT, Gabriel SE, Kremers HM. Arthritis Rheumatol. 2009;61:233-239.

    Rheum: Thank you, Brad, for that detailed case presentation. It’s great for us to connect about this patient.

    As you know, up to 30 percent of patients with psoriasis go on to develop psoriatic arthritis, so it’s great that you’re probing your patients for joint disease early. 1

    Also, it’s important not to wait until suspected joint involvement progresses. A delay in psoriatic arthritis diagnosis, even for as short as 6 months, can negatively impact long-term patient outcomes. 2

    References: 1. Van Voorhees AS, Feldman SR, Lebwohl MG, Mandelin A, Ritchlin C. https://www.psoriasis.org/pocket-guide. Accessed December 9, 2021. 2. Haroon M, Gallagher P, FitzGerald O. Ann Rheum Dis. 2015;74:1045-1050.

    Rheum: As a dermatologist, you are in an excellent position to aid in the early detection of psoriatic arthritis. 1

    You can evaluate patients by looking for symptoms such as nail disease, including pitting of the nails, which you mentioned in Steve’s case, or for dactylitis, commonly known as sausage digits. 2

    Some cases are more subtle and may not show the more recognizable signs during a physical examination. For instance, the presence of enthesitis is sometimes associated with greater delays in psoriatic arthritis diagnosis because it is often misdiagnosed as other foot problems. 3

    Dermatologists can ask patients about tenderness or pain in the entheses, pain and stiffness of the joints, or back
    pain. 2 Constitutional symptoms that you can ask about include generalized fatigue or generalized stiffness in the morning that lasts for more than 30 to 45 minutes. 4,5

    References: 1. Menter A, Korman NJ, Elmets CA, et al. J Am Acad Dermatol. 2011;65:137-174. 2. Bagel J, Schwartzman S. Am J Clin Dermatol. 2018;19:839-852. 3. Ogdie A, Nowell WB, Applegate E, et al. BMC Rheumatol.2020;4:2. 4. Gottlieb A, Korman NJ, Gordon KB, et al. J Am Acad Dermatol. 2008;58:851-864. 5. National Psoriasis Foundation. About Psoriatic Arthritis. https://www.psoriasis.org/about-psoriatic-arthritis#symptoms. Accessed November 3, 2021.

    Rheum: In Steve’s case, we see more nuanced symptoms like stiffness and fatigue, which warrant further probing. 1 You could ask the patient: Does his stiffness occur in the morning for more than 30 minutes? Does it improve with activity? If the patient says yes for either, it may further indicate psoriatic arthritis. 2

    Overall, I’d say this patient is a good candidate for referral. Given some of the subtleties of the case, a rheumatologist would be best equipped to differentiate from other arthropathies and confirm a diagnosis of psoriatic arthritis. 3

    Dermatologists are best positioned to screen since you generally have the first contact with patients who may not be aware that their joint symptoms could be related to their psoriatic disease. 4

    In general, I recommend screening all patients with psoriasis for psoriatic arthritis, especially if there are nail symptoms or any other symptoms we’ve discussed so we can catch the disease early. 4

    References: 1. National Psoriasis Foundation. About Psoriatic Arthritis. https://www.psoriasis.org/about-psoriatic-arthritis#symptoms. Accessed November 3, 2021. 2. Gottlieb A, Korman NJ, Gordon KB, et al. J Am Acad Dermatol. 2008;58:851-864. 3. Menter A, Korman NJ, Elmets CA, et al. J Am Acad Dermatol. 2011;65:137-174. 4. Bagel J, Schwartzman S. Am J Clin Dermatol. 2018;19:839-852.

    Derm: Thank you for the consultation on this case; that was all very helpful!

    Yes, I actually use the PEST tool quite often to help screen for psoriatic arthritis symptoms, and I’ve found it to be quick and straightforward. It asks 5 simple questions, which patients can fill out in the waiting room, probing for many of the symptoms we have just discussed.

    One more question for you, Andrew: If I suspect psoriatic arthritis and then refer a patient to you, how do you confirm whether it’s psoriatic arthritis?

    Rheum: Great question. In our offices, we do a comprehensive musculoskeletal evaluation.

    Specific patterns of joint inflammation, together with the absence of rheumatoid factor and the presence of skin lesions of psoriasis and nail involvement, aid us in differentiating a psoriatic arthritis diagnosis.

    While there are no specific serologic tests that confirm the diagnosis, radiographs can demonstrate the extent and location of joint damage while helping to distinguish psoriatic arthritis from rheumatoid arthritis or inflammatory osteoarthritis.

    Radiographic changes may occur early in the course of psoriatic arthritis, and therefore, radiographs, and, in some cases, MRI or ultrasound can be helpful in detecting asymptomatic disease.

    Derm: Thank you for your insight on how a diagnosis can be confirmed; so glad we had the opportunity to talk. I’ll definitely refer patients with more nuanced symptoms such as the ones we discussed today. Whatever the diagnostic outcome, it’s important for us to reconnect to discuss the diagnosis and a treatment plan that works for both the patient’s psoriasis and joint symptoms.

    Treatment guidelines from various organizations emphasize the importance of co-management of patients with psoriasis and psoriatic arthritis by dermatologists and rheumatologists. 1,2

    Additionally, studies have shown that multidisciplinary care through collaboration between dermatologists and rheumatologists can improve patient outcomes, with early, more accurate diagnosis leading to prompt intervention. 3

    References: 1. Coates LC, Kavanaugh A, Mease PJ, et al. Arthritis Rheumatol. 2016;68:1060-1071. 2. Elmets CA, Leonardi CL, Davis DMR et al. J Am Acad Dermatol. 2019;80:1073-1113. 3. Soleymani T, Reddy SM, Cohen JM, Neimann AL. Curr Rheumatol Rep.
    2018;20:1-8.

    Rheum: Yes, a study out of Brigham and Women’s found that care in multidisciplinary clinics led to the modified management of psoriatic disease, including an over 20 percent reduction in the use of topical monotherapy and over 50 percent increase in the use of systemic medication. 1

    In another clinic, multidisciplinary collaboration led to increased satisfaction, with 93 percent of patients rating their care as better or much better, and all patients rating their disease as better controlled. 2

    References: 1. Velez NF, Wei-Passanese EX, Husni ME, Mody EA. Arch Dermatol Res. 2012;304:7-13. 2. Urruticoechea-Arana, Torres MS, Diaz MH, et al. Rheumatol Clin (Engl Ed).2019;15:237-241.

    Derm: So far, we’ve discussed some key insights into co-management of patients with psoriatic disease.

    First, delays in psoriatic arthritis diagnosis can impact long-term patient outcomes so we strongly recommend screening all psoriasis patients for psoriatic arthritis. 1,2

    Additionally, co-management of patients with psoriatic disease by dermatologists and rheumatologists is recommended for improved patient outcomes. 3

    References: 1. Haroon M, Gallagher P, FitzGerald O. Ann Rheum Dis. 2015;74:1045-1050. 2. Bagel J, Schwartzman S. Am J Clin Dermatol.2018;19:839-852. 3. Urruticoechea-Arana, Torres MS, Diaz MH, et al. Rheumatol Clin (Engl Ed).2019;15:237-241.

    Derm: Let’s now talk about available treatments. A systemic treatment option that is available is Otezla.

    VO: Indications: Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

    Important Safety Information

    Contraindications: Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.

    VO: Warnings and Precautions

    Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy.

    Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting.

    Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts or behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur.

    Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% of patients reported depression compared to 0.4% on placebo. Depression was reported as serious in 0.1% of patients exposed to Otezla, compared to none in placebo-treated patients. Suicidal behavior was observed in 0.1% of patients on Otezla, compared to 0.2% on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide.

    Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% reported depression or depressed mood compared to 0.8% treated with placebo. Suicidal ideation and behavior was observed in 0.2% of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% of patients exposed to Otezla, compared to none in placebo-treated patients. Two patients who received placebo committed suicide compared to none on Otezla.

    Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla.

    Plaque Psoriasis: Body weight loss of 5 to 10% occurred in 12% of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% of patients treated with placebo. Body weight loss of 10% or more occurred in 2% of patients treated with Otezla compared to 1% of patients treated with placebo.

    Psoriatic Arthritis: Body weight loss of 5 to 10% was reported in 10% of patients taking Otezla and in 3.3% of patients taking placebo.

    Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (for example, rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended.

    Adverse Reactions

    Plaque Psoriasis: The most common adverse reactions (5% or more) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in patients with mild to moderate plaque psoriasis was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis

    Psoriatic Arthritis: The most common adverse reactions (5% or more) are diarrhea, nausea, and headache.

    Use in Specific Populations

    Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss.

    Please see the Full Prescribing Information for Otezla provided on OtezlaPro.com.

    Derm: Thank you for listening. Click one of these options to learn more about the Otezla clinical data in patients with plaque psoriasis or in patients with psoriatic arthritis, or to explore our other Otezla learning videos.

    Chapter 2

    Derm: Hello again. As we just discussed in the previous chapter, Steve was diagnosed with mild to moderate plaque psoriasis 10 years ago, presents with plaques on his back, elbows, shins, and scalp, and he has significant pruritus.

    Steve originally used over-the-counter NSAIDs and several types of topicals, which are associated with many challenges. 1,2

    Considering the challenges with topicals, and the fact that the plaques on his scalp, elbows, and shins were resistant to topical steroids, I decided it was time to progress to a systemic treatment, so I prescribed him Otezla.

    In this chapter, we’ll review the Otezla clinical data from its pivotal trials.

    References: 1. Feldman SR, Goffe B, Rice G, et al. Am Health Drug Benefits. 2016;9:504-513. 2. Brown KK, Reuhmus WE, Kimball AB.
    J Am Acad Dermatol.
    2006;55:607-613.

    Derm: I’ll start by reviewing the pivotal trials in plaque psoriasis, and then Dr. Sulich will present the pivotal trials in psoriatic arthritis.

    Derm: Otezla was evaluated in a phase 3, randomized, multicenter, double-blind, placebo-controlled trial for the treatment of mild to moderate plaque psoriasis known as ADVANCE.

    Select inclusion criteria included an sPGA of 2 or 3, BSA involvement of 2 to 15 percent, and a PASI score ranging from 2 to 15, all indicative of mild to moderate disease. Patients also had an inadequate response to 1 or more topical therapies and were candidates for phototherapy or systemic therapy. No prior biologic therapy was allowed.

    Derm: A total of 595 biologic-naïve patients were randomized 1:1 to Otezla 30 mg twice a day, or BID, or placebo for 16 weeks. This was followed by a 16-week extension phase in which all patients were switched to or continued with Otezla 30 mg BID, and a 4-week post-treatment observation phase. 1,2

    References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Stein Gold L, Papp, K, Pariser, D, et al. J Am Acad Dermatol. 2022;86:77-85.

    Derm: The primary endpoint of ADVANCE was the proportion of patients achieving an sPGA score of 0, indicating clear skin, or 1, indicating almost clear skin, with at least a 2-point reduction from baseline at week 16.

    Selected secondary endpoints included assessments of whole body itch and scalp disease, such as the proportion of patients who achieved at least a 4-point improvement from baseline in whole body itch and a scalp Physician’s Global Assessment, or ScPGA, score of 0 or 1, with at least a 2-point reduction from baseline.

    Derm: Here, we can see the primary endpoint was achieved in the ADVANCE trial. Otezla treatment resulted in significantly more patients achieving an sPGA response of 0 or 1 at week 16, compared with placebo. 1

    Patients taking Otezla demonstrated improved itch response at week 16, with 43.2 percent of patients achieving an improvement in whole body itch compared with 18.6 percent of patients on placebo. 2

    Additionally, Otezla resulted in improvements in scalp response at week 16, with 44 percent of patients on Otezla achieving an ScPGA score of clear or almost clear compared with 16.6 percent of patients on placebo. 2

    References: 1. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86:77-85. 2. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

    Derm: Otezla was also evaluated in 2 double-blind, multicenter, randomized, placebo-controlled trials of similar design, known as ESTEEM 1 and 2. Selected inclusion criteria included: an sPGA of at least 3, indicative of moderate to severe disease, BSA involvement of at least 10 percent, and a PASI score of at least 12. Patients were also candidates for phototherapy or systemic therapy. 1,2

    References: 1. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;75:37-49. 2. Paul C, Cather J, Gooderham M, et al.
    Br J Dermatol. 2015;173:1387-1399.

    Derm: A total of 1257 patients with moderate to severe plaque psoriasis were randomized 2:1 to either Otezla 30 mg BID or placebo. 1,2

    At week 16, all patients originally assigned to placebo were transitioned to receive Otezla. At week 32, based on clinical response, some patients originally randomized to the Otezla arm were re-randomized to receive Otezla or placebo; those re-randomized to placebo restarted Otezla at loss of response, but no later than week 52. 1,2

    References: 1. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;75:37-49. 2. Paul C, Cather J, Gooderham M, et al.
    Br J Dermatol. 2015;173:1387-1399.

    Derm: The primary endpoint of the study was the proportion of patients achieving a PASI-75, or 75 percent clearer skin, at week 16. 1,2

    Selected exploratory endpoints included assessments of nail and scalp disease such as the mean percent change in the Nail Psoriasis Severity index, or NAPSI, score and the proportion of patients who achieved an ScPGA score of 0, indicating clear skin, or 1, indicating almost clear skin.

    References: 1. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;75:37-49. 2. Paul C, Cather J, Gooderham M, et al.
    Br J Dermatol. 2015;173:1387-1399.

    Derm: Here, we can see the primary endpoint was achieved in the ESTEEM trials. Otezla treatment resulted in significantly more patients achieving a PASI-75 response at week 16 compared with placebo in both ESTEEM 1 and ESTEEM 2. 1,2

    In ESTEEM 1, 47 percent of patients taking Otezla achieved an ScPGA score of clear or minimal at week 16, compared with 18 percent of patients on placebo. 1

    In patients taking Otezla, there was a 23 percent improvement in mean percentage change in NAPSI scores compared with a
    7 percent decrease in patients treated with placebo at week 16. 1

    If you're interested in learning more about Otezla, please view our other learning videos to hear my colleague Dr. Jennifer Cather discuss the STYLE trial.

    References: 1. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;75:37-49. 2. Paul C, Cather J, Gooderham M, et al.
    Br J Dermatol. 2015;173:1387-1399.

    Derm: Here we see some examples of results in Otezla patients on the legs and thighs at week 16 and week 32, and on the scalp and nails at week 16.

    Note that individual results may vary, and NAPSI scores were not captured in this patient population. The nail images are reflective of a patient with a 76.5 percent reduction in PASI score at week 16.

    Derm: In terms of safety, adverse events reported in at least 5 percent of patients on Otezla in ADVANCE included diarrhea, nausea, headache, nasopharyngitis, and upper respiratory tract infection. 1 In ESTEEM, adverse events reported in at least 5 percent of patients on Otezla were diarrhea, nausea, headache, nasopharyngitis, upper respiratory tract infection, and tension headache. 1

    The proportion of patients with psoriasis who discontinued treatment due to any adverse reaction was 6.1 percent for Otezla-treated patients and 4.1 percent for placebo-treated patients in the ESTEEM trial. 2 The proportion of patients with psoriasis who discontinued treatment due to any adverse event was 2.4 percent for Otezla-treated patients and 2.3 percent for placebo-treated patients in the ADVANCE trial. 3

    Postmarketing reports of severe diarrhea, nausea, and vomiting have been associated with the use of Otezla. In some cases, patients were hospitalized. Please monitor patients who are more susceptible to complications of diarrhea or vomiting. 2

    References: 1. Data on file, Amgen Inc. 2. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 3. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86:77-85.

    Derm: Here we can see selected marked abnormalities in laboratory parameters as assessed in the ESTEEM trials.

    Please note: the Prescribing Information for Otezla has no requirement for baseline or routine lab monitoring.

    Derm: Now, I’ll give the floor over to Andrew, who will present the pivotal clinical data in psoriatic arthritis.

    Rheum: Thank you, Brad.

    Rheum: Otezla was evaluated in one of the largest global clinical development programs ever conducted in psoriatic arthritis. 1 The approval of Otezla was based on the results of 3 multicenter, double-blind, randomized, placebo-controlled, phase 3 studies known as PALACE 1, 2, and 3. 2

    These studies enrolled patients showing active psoriatic arthritis, defined as having at least 3 swollen joints and at least 3 tender joints, despite prior or current DMARD therapy. 2

    Selected exclusion criteria included patients who failed more than 3 small-molecule agents or biologics for psoriatic arthritis, or who failed more than 1 biologic TNF blocker. 2

    Reference: 1. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21:118; 2. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

    Rheum: The PALACE 1, 2, and 3 studies had a similar design. During the placebo-controlled phase, patients were randomized to receive Otezla 20 mg or 30 mg BID or placebo. The primary endpoint was the percentage of patients achieving a 20 percent improvement in joint symptoms as measured by an ACR20 response at week 16. 1

    All patients in the placebo group whose tender or swollen joint counts had not improved by at least 20 percent at week 16 were re-randomized to 1 of the Otezla treatment groups. At week 24, patients entered the blinded active treatment phase, and all remaining patients on placebo were re-randomized to active treatment with Otezla. After 1 year, patients could continue in the long-term, open-label extension phase of the trial.1,2

    References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Kavanaugh A, Gladman DD, Edwards CJ, et al.
    Arthritis Res Ther. 2019;21:118.

    Rheum: In these PALACE 1-3 studies, significantly more patients on Otezla 30 mg BID met the primary endpoint of an ACR20 response at week 16 than patients on placebo.

    Treatment with Otezla also resulted in improvement of enthesitis and dactylitis in patients with preexisting enthesitis and dactylitis. If you are interested in learning more, please view our learning video on Otezla data in patients with psoriatic arthritis.

    Rheum: To summarize some key facts about Otezla: First, patients can start today with no label-required monitoring. 1 Otezla is the first and only oral therapy approved for active psoriatic arthritis and across all severities of plaque psoriasis. And lastly, Otezla has an established safety profile in a range of patients with plaque psoriasis across multiple clinical trials. 2

    References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc.

    Rheum: Thank you for listening. Click on one of these options to learn more about Otezla mechanisms of action, the STYLE trial, or getting your patients started on Otezla.

NRS, numeric rating scale; ScPGA, Scalp Physician Global Assessment.

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IMPORTANT SAFETY INFORMATION 

Contraindications

Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation 

Warnings and Precautions

Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

  • Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy
  • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
  • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
    • Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
    • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
    • Behçet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
  • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider
    discontinuation of Otezla
    • Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
    • Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
    • Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of
      patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Plaque Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in patients with mild to moderate plaque psoriasis was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis
  • Psoriatic Arthritis: The most common adverse reactions (≥5%) are diarrhea, nausea, and headache
  • Behçet’s Disease: The most common adverse reactions (≥10%) are diarrhea, nausea, headache, and upper respiratory tract infection

Use in Specific Populations

  • Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss

Please click here for the full Prescribing Information.

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for
phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.