3 INDICATIONS

3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Read more

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

Otezla OnDemand Modules

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

After watching Chapter 1, Chapter 2 will become available to you

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 psoriasis patients, and the importance of communication between specialties for the successful comanagement of patients.

Chapter 2:

Otezla Is the Only Oral Therapy Indicated for Plaque Psoriasis and Psoriatic Arthritis1

Explore data from the ESTEEM trials in moderate to severe plaque psoriasis and the PALACE trials in active psoriatic arthritis.

Video transcript

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

CHAPTER 1

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, the Chief of Rheumatology at Ascension Saint John Medical Center in Detroit, Michigan. Derm: Today, we’ll discuss the importance of joint care between rheumatology and dermatology 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, Michael was diagnosed with plaque psoriasis 5 years ago and presents with plaques on his back, elbows, and scalp. He has significant itch symptoms, and examination of his nails revealed some pitting. Derm: Based on Michael’s affected BSA, his plaque psoriasis is moderate to severe.1 Michael originally used several topicals 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,2-4 plus the fact that the plaques on his scalp 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. Michael mentioned joint symptoms like knee and foot pain, though he initially attributed this pain to his job doing manual labor. I probed further to see if he has had any other joint pain, and he mentioned some stiffness over the last two months. I was concerned these symptoms could be a sign of psoriatic arthritis, especially with what we know about psoriatic arthritis and nail and scalp psoriasis.5-7 Derm: They’re both fairly common in patients with psoriatic arthritis.5-7 Also, data suggest that nail psoriasis may be associated with a higher risk for psoriatic arthritis.5 Given Michael’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? 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% 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 a psoriatic arthritis diagnosis, even a delay as short as 6 months, can negatively impact long-term patient outcomes.8 Rheum: As a dermatologist, you are in an excellent position to aid in the early detection of psoriatic arthritis.9 You can evaluate patients by looking for symptoms such as nail disease, including pitting of the nails, which you mentioned in Michael’s case, or for dactylitis, commonly known as sausage digits.10 Some cases are more subtle and may not show these more recognizable signs during a physical exam. Dermatologists can also ask patients about tenderness or pain in the entheses, pain and stiffness of the joints, or back pain.10 Constitutional symptoms that you can ask about include generalized fatigue or general stiffness in the morning that lasts for more than 30 to 45 minutes.11,12 Rheum: In Michael’s case, we see more nuanced symptoms like stiffness and fatigue, which warrant further probing. 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.10-12 Overall, I’d say this patient is a good candidate for a referral. Given some of the subtleties of this case, a rheumatologist would be best equipped to differentiate it from other arthropathies and confirm a diagnosis of psoriatic arthritis.1,9

Dermatologists are best positioned to screen since you generally have first contact with patients who may not be aware that their joint symptoms could be related to their psoriatic disease.3 In general, I recommend screening all patients with psoriasis for psoriatic arthritis, especially if there are nail symptoms or any of the other symptoms we’ve discussed so we can catch the disease early.5,9,10 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 to probe for psoriatic arthritis symptoms, and I’ve found it to be quick and straightforward. It asks 5 simple questions that patients can fill out in the waiting room, probing for many of the symptoms we have just discussed.13,14 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 and nail lesions of psoriasis, aid us in differentiating a psoriatic arthritis diagnosis.11

While there are no specific serologic tests that can 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.11 Radiographic changes may occur early in the course of psoriatic arthritis, and therefore, radiographs, and in some cases, MRI or CT, can be helpful in detecting asymptomatic disease.11 Derm: Thank you for your insight on how a diagnosis can be confirmed; I’m so glad we had an 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.15,16 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.17 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% reduction in the use of topical monotherapy and over 50% increase in the use of systemic medication.18 In another clinic, multidisciplinary collaboration led to increased patient satisfaction, with 93% of patients rating their care as better or much better, and all patients rated their disease as better controlled.19 Derm: So far, we’ve discussed some key insights into co-management of patients with psoriatic disease. First, delays in a psoriatic arthritis diagnosis can impact long-term patient outcomes so we strongly recommend screening all psoriasis patients for psoriatic arthritis.8,10 Additionally, co-management of patients with psoriatic disease by dermatologists and rheumatologists is recommended for improved patient outcomes.15,16,19 Derm: Let's now talk about available treatments. A systemic treatment option that is available is Otezla.20 Derm: Otezla is an oral non-biologic, PDE4 inhibitor20 indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla is also indicated for adult patients with active psoriatic arthritis. Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation. Derm: It’s important to note that cases of severe diarrhea, nausea, and vomiting have been reported with the use of Otezla. However, most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. We should be mindful that 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. Additionally, we should monitor patients who are more susceptible to complications of diarrhea or vomiting, and advise patients to contact their healthcare provider. Otezla dose reduction or suspension should be considered if patients develop severe diarrhea, nausea, or vomiting. Rheum: Treatment with Otezla is also associated with an increase in depression. When prescribing Otezla, we also need to carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts or behaviors, 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 they notice such changes. Please review the percentages shown on screen for patients experiencing depression on Otezla versus placebo. Please also note the serious adverse events of depression and suicidal behavior, as well as the number of patients who attempted or committed suicide. Derm: Keep in mind that the warnings and precautions for the use of Otezla in psoriasis and psoriatic arthritis include weight decrease and drug interactions. Otezla treatment is associated with weight decrease. In the psoriasis trials, a body weight loss of 5 to 10 percent occurred in 12% of patients treated with Otezla and in 5% of patients treated with placebo. A body weight loss of 10% or more occurred in 2% of patients treated with Otezla and in 1% of patients treated with placebo. In the psoriatic arthritis trials, a body weight loss of 5 to 10 percent occurred in 10% of patients treated with Otezla and in 3.3% of patients treated with placebo. Therefore, we should monitor body weight regularly, evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla. In terms of drug interactions, apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer, indicating loss of Otezla efficacy may occur. Additionally, concomitant use of Otezla with CYP450 enzyme inducers is not recommended. Derm: The most common adverse reactions reported in at least 5% of patients taking Otezla across the psoriasis trials include diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. In the psoriatic arthritis trials, adverse reactions reported in at least 2% of patients taking Otezla similarly included diarrhea, nausea, headache, and upper respiratory tract infection, as well as vomiting, nasopharyngitis, and upper abdominal pain. Rheum: When prescribing Otezla, it’s important to note that Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss, and consider pregnancy planning and prevention for females of reproductive potential. Note that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling the phone number listed on the slide, or visiting the MotherToBaby.org website. Additionally, there are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition. The dosage of Otezla should be reduced to 30 milligrams once daily in patients with severe renal impairment, as defined by a creatinine clearance of less than 30 milliliters per minute. For details, please see the full Prescribing Information 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 moderate to severe plaque psoriasis or in patients with psoriatic arthritis, or to explore our other Otezla learning videos.

References: 1. Van Voorhees AS, Feldman SR, Lebwohl MG, et al. The Psoriasis and Psoriatic Arthritis Pocket Guide. 5th ed. www.psoriasis.org/pocket-guide. Accessed November 19, 2020. 2. Feldman SR, Goffe B, Rice G, et al. Am Health Drug Benefits. 2016;9:504-513. 3. Brown KK, Reuhmus WE, Kimball AB. J Am Acad Dermatol. 2006;55:607-613. 4. Alinia H, Moradi Tuchayi S, Smith JA, et al. Br J Dermatol. 2017;176:759-764. 5. Yan D, Ahn R, Leslie S, et al. Dermatol Ther (Heidelb). 2018;8:593-604. 6. Yang Q, Qu L, Tian H, et al. J Eur Acad Dermatol Venereol. 2011;25:1409-1414. 7. Spelman L, Su JC, Fernandez-Peñas P, et al. J Eur Acad Dermatol Venereol. 2015;29:2184-2191. 8. Haroon M, Gallagher P, FitzGerald O. Ann Rheum Dis. 2015;74:1045-1050. 9. Menter A, Korman NJ, Elmets CA, et al. J Am Acad Dermatol. 2011;65:137-174. 10. Bagel J, Schwartzman S. Am J Clin Dermatol. 2018;19:839-852. 11. Gottlieb A, et al. J Am Acad Dermatol. 2008;58:851-864. 12. National Psoriasis Foundation. https://www.psoriasis.org/about-psoriatic-arthritis#symptoms. Accessed November 19, 2020. 13. Ibrahim GH, Buch MH, Lawson C, et al. Clin Exp Rheumatol. 2009;27:469-474. 14. Mease PJ, Palmer JB, Hur P, et al. J Eur Acad Dermatol Venereol. 2019;33:886-892. 15. Coates LC, Kavanaugh A, Mease PJ, et al. Arthritis Rheumatol. 2016;68:1060-1071. 16. Gossec L, Smolen JS, Ramiro S, et al. Ann Rheum Dis. 2016;75:499-510. 17. Soleymani T, Reddy SM, Cohen JM, et al. Curr Rheumatol Rep. 2018;20:1-8. 18. Velez NF, Wei-Passanese EX, Husni ME, et al. Arch Dermatol Res. 2012;304:7-13. 19. Urruticoechea-Arana A, Torres MS, Diaz MH, et al. Reumatol Clin. 2019;15:237-241. 20. Otezla [package insert]. Thousand Oaks, CA: Amgen, Inc.

CHAPTER 2

Derm: Hello again. As we just discussed in the previous chapter, Michael was diagnosed with moderate to severe plaque psoriasis 5 years ago and presents with plaques on his back, elbows, and scalp, and he has significant pruritus. Michael originally used several topicals, which are associated with many challenges.1,2 Considering these challenges, and the fact that the plaques on his scalp were resistant to topicals, 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. Derm: I’ll start by reviewing the pivotal trials in moderate to severe plaque psoriasis, and then Dr. Sulich will present the pivotal trials in psoriatic arthritis. Derm: Otezla was evaluated in 2 double-blind, placebo-controlled trials of similar design, known as ESTEEM® 1 and 2. A total of 1257 patients with moderate to severe plaque psoriasis were randomized 2:1 to either Otezla 30 mg twice daily or placebo.3-5 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 52.4,5 Derm: Selected inclusion criteria include an sPGA of at least 3, indicative of moderate to severe disease, BSA involvement of at least 10%, and a PASI score of at least 12. Patients were also candidates for phototherapy or systemic therapy.3-6 Derm: The primary endpoint of the study was the proportion of patients achieving a PASI-75, or 75% clearer skin, at week 16.3-5 Selected exploratory endpoints include 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 a scalp Physician’s Global Assessment, or scalp PGA, score of 0, indicating clear skin, or 1, indicating almost clear skin.4,5 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 2.3-5 In ESTEEM 1, 47% of patients taking Otezla achieved a scalp PGA score of clear or minimal at week 16, compared to 18% of patients on placebo.4 If you're interested in learning more about Otezla, please view our other learning videos to hear my colleague Dr. Cather discuss the STYLE trial. In patients taking Otezla, there was a 23% improvement in mean percentage change in NAPSI scores compared with a 7% worsening in patients treated with placebo at week 16.4 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 16.6 Note that individual results may vary, and nail images are not reflective of NAPSI scores. The nail images are reflective of a patient with a PASI-76.5 response at week 16.6 Derm: In terms of safety, adverse reactions reported in at least 5% of patients on Otezla in 3 clinical trials, including ESTEEM®, were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.3 The proportion of patients with psoriasis who discontinued treatment due to any adverse reaction was 6% for Otezla-treated patients and 4% for placebo-treated patients.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.3 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.3 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.7 The approval of Otezla was based on the results of 3 multicenter, randomized, placebo-controlled, Phase 3 studies known as PALACE 1, 2, and 3.3 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.3 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.3 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 twice daily or placebo. The primary endpoint was the percentage of patients achieving a 20% improvement in joint symptoms as measured by an ACR20 response at week 16.3 All patients in the placebo group whose tender or swollen joint counts had not improved by at least 20% at week 16 were re-randomized to one of the Otezla treatment groups. At week 24, patients entered the blinded active treatment phase, and all remaining placebo patients 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.3,7 Rheum: In these PALACE 1-3 studies, significantly more patients on Otezla 30 mg twice daily met the primary endpoint of an ACR20 response at week 16 than patients on placebo.3,6 Treatment with Otezla also resulted in improvement of enthesitis and dactylitis in patients with preexisting enthesitis and dactylitis.3 If you are interested to learn more, please view our learning video on Otezla data in patients with psoriatic arthritis. Rheum: In terms of safety, adverse reactions reported in at least 2% of patients on Otezla in the PALACE 1, 2, and 3 studies were diarrhea, nausea, headache, upper respiratory tract infection, vomiting, nasopharyngitis, and upper abdominal pain. These symptoms occurred at a frequency at least 1% higher than that observed in patients taking placebo and days 1 to 5 represent the initial dose titration phase for Otezla.3 Rheum: To summarize some key facts about Otezla: first, there is no requirement for routine laboratory monitoring from the Prescribing Information.3 Additionally, Otezla is the only oral treatment indicated for psoriatic arthritis and moderate to severe plaque psoriasis.3,6 And lastly, with an FDA approval in 2014, Otezla has been on the market for 6 full years.3 Rheum: Thank you for listening. Click one of these options to learn more about the Otezla mechanism of action, the STYLE trial, or getting your patients started on Otezla.

References: 1. Feldman SR, Goffe B, Rice G, et al. Am Health Drug Benefits. 2016;9:504-513. 2. Brown KK, Rehmus WE, Kimball AB, et al. J Am Acad Dermatol. 2006;55:607-613. 3. Otezla [package insert]. Thousand Oaks, CA: Amgen, Inc. 4. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73:37-49. 5. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173:1387-1399. 6. Data on file, Amgen Inc. 7. Kavanaugh A, et al. Arthritis Res Ther. 2019;21:118.

ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy.

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IMPORTANT SAFETY INFORMATION

Contraindications

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

Warnings and Precautions

  • 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
    • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 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
    • Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients 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

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
  • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
  • Behçet’s Disease: Adverse reactions reported in ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

Use in Specific Populations

  • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
  • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
  • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe 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.

Reference: 1. Data on file, Amgen Inc.