Video Library about PsO, PsA, and BD

VIDEO TRANSCRIPTS

A Treat-to-Target Approach for Patients with Psoristic Arthritis Using cDAPSA, click here

Otezla Is an Oral Treatment Option for Use in Psoriatic Arthritis Patients ¹

Otezla®, apremilast, is an oral treatment option for first-line systemic use in patients with psoriatic arthritis.

Please see Important Safety Information within this video and Full Prescribing Information on OtezlaPro.com.

Indication:

Otezla® (apremilast) is indicated for the treatment of adult patients with active psoriatic arthritis.

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

Before we explore the clinical trials for Otezla in patients with psoriatic arthritis, ¹ let’s look at some important safety information.

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. 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. 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.

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, randomized, placebo-controlled phase 3 studies: PALACE 1, 2, and 3. ² The efficacy and safety of Otezla were examined in disease-modifying antirheumatic drug, or DMARD, and/or biologic-naïve patients in the PALACE 4 study. ³

Let’s focus our attention on PALACE 4 and Otezla in DMARD- and/or biologic-naïve patients. ³ All 4 PALACE studies enrolled patients of 18 or more years of age with active psoriatic arthritis, defined as having at least 3 swollen joints and at least 3 tender joints. ^1-4 Patients in PALACE 1, 2, and 3 had active psoriatic arthritis, despite prior or current DMARD therapy. ^1-3 Only DMARD-naïve patients were allowed in PALACE 4 and the only concomitant therapies allowed were NSAIDs and corticosteroids. ⁴

All 4 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. ^1,2 The primary endpoint was the percentage of patients achieving an ACR20 response at Week 16. ^1,2 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. ^1,2 At Week 24, patients entered the blinded active-treatment phase, and all remaining placebo patients were re-randomized to active treatment with Otezla. ^1,2 After 1 year, patients could continue in the long-term open-label extension of the trial.

Despite being DMARD-naïve, PALACE 4 patients had considerable disease activity at baseline; the mean duration of disease at baseline was 3.4 years, and the mean disease activity score in 28 joints using C-reactive protein—or DAS28-CRP—was 4.6. ^1,2 In PALACE 1-3, the mean age was 50 years, the mean duration of psoriatic arthritis at baseline was 7.4 years, and the mean
DAS28-CRP was 4.7. ²

Significantly more patients on Otezla 30 mg twice daily met the primary endpoint of ACR20 response at Week 16 than patients on placebo in all 4 PALACE studies. In PALACE 4, 31% of DMARD-naïve patients on Otezla achieved an ACR20 response at
Week 16 compared with 16% of patients on placebo. ^1-6 ACR20 response was captured through 5 years. ¹ In PALACE 4, the proportion of patients achieving an ACR20 response was 66% at 5 years. ¹ Consider open label extension study limitations when interpreting results. The open label extension is not blinded, not controlled, and includes inherent self-selection bias. ¹

Of importance to patients with psoriatic arthritis, Otezla has 5-year data on the following manifestations and symptoms. Let’s dive deeper into these data. ¹

Joint tenderness and swelling are 2 of the main symptoms of psoriatic arthritis. ¹ At 5 years, the mean percent reduction in tender joint count, or TJC, was -76% and the mean percent reduction in swollen joint count, or SJC, was -85%. ¹

Dactylitis and enthesitis are also distinguishing features of psoriatic arthritis. ¹ Based on a review of 157 publications on dactylitis and enthesitis in patients with psoriatic arthritis, dactylitis occurs in up to 53% of patients and enthesitis occurs in up to 78% of patients with psoriatic arthritis. ² Of the patients in PALACE 4 with preexisting dactylitis, the percentage of patients whose dactylitis resolved was 39% at Week 16 and 95% at 5 years. ¹ In PALACE 4, of the DMARD-naïve patients with preexisting enthesitis, the percentage of patients who achieved resolution of enthesitis was 35% at Week 16 and 71% at 5 years. ¹

Let’s turn our attention to the safety profile of Otezla.

Adverse Reactions:

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.

The most common adverse reactions with Otezla were diarrhea, nausea, and headache.

The majority of diarrhea and nausea generally occurred within the first 2 weeks of treatment and tended to resolve
within 4 weeks with continued dosing. ¹ There have been reports of severe cases of diarrhea, nausea, and vomiting associated with the use of Otezla. In some cases patients were hospitalized. Be sure to monitor patients who are more susceptible to complications of diarrhea or vomiting. ² Overall through Week 24, 3.4% of patients taking Otezla discontinued treatment because of any adverse reaction compared with 2.3% of placebo-treated patients. ¹

The long-term safety profile of Otezla was consistent through 5 years of exposure in the PALACE 4 clinical trial study of DMARD-naïve patients with active psoriatic arthritis. ¹

Otezla is an oral treatment for adults with active psoriatic arthritis. It has the first and largest study in DMARD-naïve psoriatic arthritis patients and may be used as a first-line systemic treatment option. Furthermore, it has 5 years of efficacy and safety data available. ^1,2 For more information about Otezla and its other indications, including the efficacy and safety profile, please see the full Prescribing Information for Otezla, provided on OtezlaPro.com.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen, Inc. 2. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57:1253-1263. 3. Data on file, Amgen Inc. 4. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Ann Rheum Dis. 2014;73:1020-1026. 5. Cutolo M, Myerson GE, Fleischmann RM, et al. J Rheumatol. 2016;43:1724-1734. 6. Edwards CJ, Blanco FJ, Crowley J, et al. Ann Rheum Dis. 2016;75:1065-1073. 7. Gottlieb A, Korman NJ, Gordon KB, et al. J Am Acad Dermatol.2008;58:85-864. 8. Mease PJ, Armstrong AW. Drugs. 2014;74:423-441. 9. Sakkas LI, Alexiou I, Simopoulou T, et al. Semin Arthritis Rheum. 2013;43:325-334.

Otezla Is the First and Only FDA-Approved Therapy for Adult Patients with Oral Ulcers Associated with Behçet’s Disease

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

Please see Important Safety Information within this video and Full Prescribing Information on OtezlaPro.com.

Behçet’s Disease is a rare, chronic, and variable vasculitis that causes inflammation of the arteries and veins across multiple organ systems. ^1-3 Hallmark characteristics of Behçet’s Disease include aphthous ulcers, commonly occurring in the oral mucosa. ¹

The clinical manifestations of Behçet’s Disease are heterogeneous and can vary from patient to patient. ¹ Despite these differences, the majority of patients with Behçet’s Disease frequently experience recurrent oral ulcers as their first manifestation. These can be bothersome and painful. ^1-4

Other clinical manifestations of Behçet’s Disease include, in decreasing prevalence, genital ulcers, skin lesions, ocular involvement, joint involvement, vascular involvement, neurological involvement, and gastrointestinal involvement. ^2,5,6 Understanding the many manifestations of Behçet’s Disease can help with diagnosis.

The International Study Group or ISG criteria can be used to diagnose Behçet’s Disease by the presence of recurrent oral ulceration plus at least 2 of the following: recurrent genital ulceration, eye lesions, skin lesions, or a positive result on pathergy testing. Otezla is the first and only therapy approved for adult patients with oral ulcers associated with Behçet’s Disease.

Indication:

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

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. 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. Body weight loss of more than 5% was reported in 4.9% of patients taking Otezla and in 3.9% 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.

Otezla was evaluated in 207 adult patients with active oral ulcers associated with Behçet’s Disease in the phase 3, multicenter, randomized, placebo-controlled RELIEF study.

All patients in the study met the ISG criteria for Behçet’s Disease, had 1 or more prior treatments with non-biologic therapy, had at least 2 oral ulcers at screening and randomization, had at least 3 occurrences of oral ulcers within 12 months prior to randomization, and were candidates for systemic therapy. ^1,2 Patients were excluded if they had active major organ involvement or prior biologic therapy for oral ulcers associated with Behçet’s Disease. ^1,2

In this study, patients were randomized 1:1 to receive either Otezla 30 mg twice daily or placebo for the first 12 weeks of the placebo-controlled treatment phase. ¹ After week 12, all patients received Otezla 30 mg twice daily for up to 64 weeks during the active treatment phase. ²

Of note, the mean age of patients included in the RELIEF study was 40 years, with a mean duration of Behçet’s Disease of
6.8 years. The mean baseline oral ulcer count was 4.2 for the Otezla arm and 3.9 for the placebo arm.

The measures of oral ulcers observed at week 12 included the following: change from baseline in the pain of oral ulcers as measured by visual analog scale scores at week 12; proportion of patients achieving oral ulcer complete response, meaning oral ulcer free, at week 12; proportion of patients achieving oral ulcer complete response by week 6, and who remained oral ulcer–free for at least 6 additional weeks during the 12-week placebo-controlled treatment phase; and daily average number of oral ulcers during the 12-week placebo-controlled treatment phase.

Let’s first look at the effect of Otezla on oral ulcer pain.

The change from baseline in oral ulcer pain, as measured by VAS scores, was statistically greater in patients treated with Otezla vs placebo, with a treatment difference of -24.1.

Now let’s look at the effect on oral ulcer complete response, characterized by the patients who were oral ulcer–free
at week 12.

There was a significantly greater proportion of patients achieving oral ulcer complete response at week 12 when treated with Otezla vs placebo, with a treatment difference of 31%.

Next, let’s look at maintenance of oral ulcer complete response.

30% of patients taking Otezla who achieved oral ulcer complete response by Week 6 remained oral ulcer–free for at least 6 additional weeks during the 12-week phase compared with 5% of patients treated with placebo, which accounts for a significant treatment difference of 25%.

Lastly, let’s look at the effect of Otezla on the number of oral ulcers over 12 weeks.

Patients taking Otezla experienced a significantly lower daily average number of oral ulcers compared with patients taking placebo.

Let’s turn our attention to the safety profile for Otezla.

Adverse Reactions: The most common adverse reactions, 10% or more, are diarrhea, nausea, headache, and upper respiratory tract infection.

The majority of patients reporting diarrhea, nausea, and vomiting did so within the first week of treatment, and the events tended to resolve over time. ¹ Postmarketing reports of severe diarrhea, nausea, and vomiting have been associated with the use of Otezla. In some cases patients were hospitalized. It is important to monitor patients who are more susceptible to complications of diarrhea or vomiting. ²

During the placebo-controlled period of the study, 2.9% of patients taking Otezla and 4.9% of those taking placebo discontinued treatment due to adverse reactions. ¹

Use in Specific Populations:

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

Otezla is the first and only approved therapy indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. For more information about Otezla and its other indications, including the efficacy and safety profile, please see the full Prescribing Information for Otezla, provided on OtezlaPro.com.

References: 1. Leonardo NM, McNeil J. Int J Rheumatol. 2015;2015:945262. 2. Zeidan MJ, Saadoun D, Garrido M, et al. Auto Immun Highlights. 2016;7. 3. Koné-Paut I. Pediatr Rheumatol Online J. 2016;14:10. 4. Kokturk A. Patholog Res Int. 2012;2012:690390. 5. Alpsoy E, Donmez L, Onder M, et al. Br J Dermatol. 2007;157(5):901-906. 6. Alpsoy E. J Dermatol. 2016;43(6):620-632. 7. Melikoğlu M, Melikoğlu MA. Acta Reumatol Port. 2014;39(1):46-53. 8. Barnes CG. History and diagnosis. In: Behçet’s Syndrome. 2010. 9. Verity DH, Wallace GR, Vaughan RW, et al. Br J Ophthalmol. 2003;87(9):1175-1183. 10. Otezla [package insert]. Thousand Oaks, CA: Amgen, Inc. 11. Data on file, Amgen Inc.

Mechanism of Action in Psoriatic Arthritis, click here

cDAPSA, clinical Disease Activity for Psoriatic Arthritis; PDE4, phosphodiesterase-4.

Multidisciplinary Care

DISCUSS THE SAFETY DATA OF AN ESTABLISHED ORAL PDE4 INHIBITOR

Dr. Feldman (Dermatologist) and
Dr. Majjhoo (Rheumatologist) discuss the safety data of the only oral therapy indicated for plaque psoriasis and psoriatic arthritis, and its distinct mechanism of action.

Sponsored by Amgen

Watch

Video discussing care-based insights in dermatology and rheumtaology

A REAL-WORLD PERSPECTIVE ON COLLABORATIVE CARE IN DERMATOLOGY & RHEUMATOLOGY

Dr. Glick (Dermatologist) and
Dr. Sulich (Rheumatologist) discuss case-based insights to recognize and manage psoriatic disease, and review data for Otezla, the only oral therapy indicated for plaque psoriasis and psoriatic arthritis.

Sponsored by Amgen

Watch

VIDEO TRANSCRIPTS

Discuss the Safety Data of an Established Oral PDE4 Inhibitor, click here

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

Peer Insights: Perspectives on Otezla

MANAGING TREATMENT EXPECTATIONS — STARTING AND STAYING ON OTEZLA

P.A. Jennifer Maiolo shares her personal experiences, and what she has found over the years works best to help patients manage treatment expectations to start and stay on Otezla treatment.

Sponsored by Amgen

"A MAJOR IMPACT": ONE PHYSICIAN'S EXPERIENCES WITH OTEZLA

Drawing on his years of experience, Dr. Orrin Troum shares a broad perspective on his overall experience with Otezla, and the impact of being able to offer his patients an oral therapy that is FDA-approved for both PsA and plaque psoriasis.

Sponsored by Amgen

VIDEO TRANSCRIPTS

Managing Treatment Expectations — Starting and Staying on Otezla

Hello! My name is Jennifer Maiolo. I think we can all agree that in our roles, we are pivotal in helping patients start and stay on appropriate treatment. I’ve worked with Otezla — apremilast — for many years…and I’m delighted to spend a few moments discussing the importance of setting treatment expectations with our patients.

Otezla®, apremilast, is an oral, nonbiologic PDE4 inhibitor indicated for the treatment of adult patients with active psoriatic arthritis. ¹ It is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation. Additional Important Safety Information will be presented at the end of this video.

Reference: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

When we’re talking to a patient who is scared, frustrated…they don’t know the terms. They don’t know the science. They may not know what psoriatic arthritis is at all. They come in really wanting education from us when it comes to, “What can I expect?” When I first diagnose someone with psoriatic arthritis, I try to start with explaining how the disease is occurring and I like to end at, “This is why treatment can potentially help you.”

If the patient is an appropriate candidate for Otezla, I move towards setting their expectations with the medication. I let them know that Otezla has been studied for numerous years, and I tell them about the studies, which evaluated patients similar to them.

As a reminder, Otezla was evaluated in 3 multicenter, double-blind, placebo-controlled Phase 3 trials of similar design for 1493 patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints), despite prior or current DMARD therapy. ^1,2

Patients who were therapeutic failures of >3 agents for PsA (small molecules or biologics) or >1 biologic TNF blocker were excluded. ^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(1):118.

For PALACE 1, significantly more patients on Otezla 30 mg twice daily met the primary endpoint of ACR20 response at Week 16 than patients on placebo. ^1,2 Of course, it’s important that I tell patients that everyone is a little bit different. You can’t set a timeline. My take-home message to them for efficacy is… “I’d like to see how you respond to therapy on Otezla for at least
4 months…and then we’re going to really reassess how it’s working for you.” When they come back for their follow-up, they might say, “I’m noticing a difference. I feel less stiff and that swollen digit is better. But my right knee still hurts. What can I expect moving forward?”

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

At that point, I talk about the 5-year data. I tell them this is a good sign – “if you’re starting to notice efficacy, there is a good chance that as you continue your treatment, that Otezla can continue working for you over time.” They love hearing that. The graph on the screen shows sustained efficacy of Otezla with results in ACR20 response through 5 years. Consider open-label extension study limitations when interpreting results. The OLE was not blinded, not controlled, and included inherent self-selection bias. Overall, from weeks 52 to 260, a total of 156 patients (30%) discontinued during the study, of which 33 patients (6.3%) discontinued due to adverse events. ^1-3

References: 1. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 2. Data on file, Amgen Inc. 3. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

These conversations about efficacy are essential. But for my patients, safety is equally important. I make sure to tell them that Otezla’s safety has been studied extensively. Then I really want to start early with a conversation about what potential side effects and tolerability could be. I get rather specific. On the screen you will see a list of adverse reactions through week 16 from the PALACE 1-3 studies. The most common adverse reactions (≥5%) were diarrhea, nausea, and headache. ¹

I start that part of the conversation by sharing the data and saying, “Most of the diarrhea and nausea adverse reactions were generally reported within the first 2 weeks of treatment…and tended to resolve within 4 weeks with continued dosing.”

Reference: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

Whenever I tell them that “There’s a really good chance that these are going to go away on their own with continued dosing” — I can see on their face this…almost a relaxed feeling. It’s important to go over all the important safety information with each patient to understand any potential risks.

When I prescribe Otezla for a patient, I really want to empower them with what they can expect…and why that 5-day titration sample is important. I tell them after an initial 5-day titration period, the maintenance dose of Otezla is 30 mg twice daily. I want them to understand before they leave the office: “Using this pack may help reduce the gastrointestinal symptoms — nausea and diarrhea — related to initial treatment with Otezla.” ¹

Reference: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

The biggest take-home is communication and follow-up. You’re sending them home with the sample pack, a pamphlet, with brochures. But you’re letting them know, “I’m still with you. Call if you have any questions.”

I tell them about Otezla Support Plus services, and that even I have called them. And I say, “Don’t be afraid to call them and the 24/7 Nursing Support too.” If you tell patients, “Use the resources, they are for you,” they are more likely to remember and use them.

A very important point I explain is that Otezla is shipped from a specialty pharmacy…and the specialty pharmacy has to connect directly with the patient. That can be a hindrance for why a patient may not start the medication in a timely manner.

I say “If you do not hear from the specialty pharmacy in 1 or 2 weeks, let us know.” Or I might say, “Keep in mind that you should answer a telephone call from a number that you don’t know – over the next few weeks – it might be the specialty pharmacy.” I also remind them again that they can call Otezla SupportPlus^TM for assistance.

I just want them to know that the conversation doesn’t have to be over. You didn’t just have that one minute to ask questions. I try to keep that open door policy, because when it comes to education and setting expectations, it’s a process that is really never-ending. They can always ask if they want to ask more questions. And it helps with compliance. To have the option of Otezla — an oral non-biologic that doesn’t require lab monitoring, ¹ and I want to help patients to see if Otezla will help them.

“A Major Impact”: One Physician’s Experiences with Otezla

I’m Dr. Orrin Troum. I started my private practice in rheumatology in 1986. We’ve seen many approaches and advances in treatment over that time. I’d like to share some of my perspective on one in particular. That’s Otezla (apremilast).

Otezla® is an oral, nonbiologic PDE4 inhibitor 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.

It is contraindicated in patients with a known hypersensitivity to Otezla® or to any of the excipients in the formulation. Please see additional Important Information included in this video and the full Prescribing Information provided on OtezlaPro.com.

When I used to think about psoriatic arthritis, it was just that – arthritis – which is inflammation of the joints. We of course know now that psoriatic arthritis (PsA) can manifest across multiple domains. One important way that I diagnose patients with psoriatic arthritis is to watch out for signs and symptoms of plaque psoriasis, since approximately 85% of patients with PsA develop psoriasis (PsO) before experiencing joint symptoms. ^1-3

And while psoriasis can sometimes be quite obvious, it’s the hidden signs that you really have to look for, like in the scalp or nails. Similarly, psoriatic arthritis patients may have enthesitis you have to ask about, or dactylitis – “sausage digits” – in their hands, but they have it in their toes as well…and without looking you don’t know. ^1-3

References: 1. Coates LC, Helliwell PS. Clin Med (Lond). 2017;17:65-70. 2. Gottlieb A, et al. J Am Acad Dermatol. 2008;58:851-864. 3. National Psoriasis Foundation. About Psoriatic Arthritis. https://www.psoriasis.org/about-psoriatic-arthritis. Access November 3, 2021.

Otezla has had a major impact for my patients. And I’m thrilled that I can actually offer them a medication that is the first oral therapy that’s approved for both PsA and PsO. Otezla is an oral, non-biologic, systemic therapy with no label-required lab monitoring.

Let me give you an example of a patient who comes to see me. A former football player – a big guy, 6 foot 4, 240 pounds. In addition to his joint symptoms, he came in with obvious plaque psoriasis.

He probably had about 10% body surface area (BSA) of psoriasis. He had pretty significant nail psoriasis. I told him how Otezla helped some patients with moderate to severe psoriasis get clearer skin and also help their nail psoriasis. And I told him that I thought that this might be a good start for him since he already tried prescription topicals and they didn’t work for him. He liked the idea of taking a pill.

Otezla was evaluated in 2 similarly designed double-blind, placebo-controlled Phase 3 trials, ESTEEM 1 and 2, for 1,257 patients with moderate to severe plaque psoriasis for at least 12 months, including a static Physician’s Global Assessment of at least 3; BSA of at least 10%; and a Psoriasis Area and Severity Index, or PASI, score of at least 12. ^1-3

They were also candidates for phototherapy or systemic therapy. Prior systemic therapy was permitted. ^1-3

In ESTEEM 1, significantly more patients on Otezla 30 mg twice daily met the primary endpoint of PASI-75, or 75% clearer skin at week 16 than patients on placebo. ^1-3

References: 1. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 2. Paul C, Cather J, Gooderham M,
et al. Br J Dermatol. 2015;173(6):1387-1399. 3. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

Also, in ESTEEM 1, patients on Otezla 30 mg twice daily demonstrated reduction in mean nail psoriasis severity index scores compared to placebo at 16 weeks. ¹ And when I ended up seeing the football player back after 4 months of treatment, he was already starting to see improvement — in his plaque psoriasis and his nails.

References: 1. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49.

When I am setting treatment expectations with Otezla, I’m very upfront. We talk about the potential side effects and I prepare the patient for that. Otezla has an established safety profile. The most common adverse reactions in ≥5% of patients in the ESTEEM trials were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. ¹

Reference: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

I share that “Most of the diarrhea and nausea were reported within the first 2 weeks…and the events tended to resolve within
4 weeks with continued dosing.” It’s that conversation — that open discussion — that’s important.

With Otezla, you also have the well-controlled PALACE studies, where 1493 patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints), despite prior or current DMARD therapy, were evaluated in 3 multicenter, double-blind, placebo-controlled Phase 3 trials of similar design. ^1,2

Patients who were therapeutic failures of >3 agents for PsA (small molecules or biologics) or >1 biologic TNF blocker were excluded. ^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(1):118.

For PALACE 1, significantly more patients on Otezla 30 mg twice daily met the primary endpoint of ACR20 response at week 16 than patients on placebo. ^1,2

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

I think it's important for physicians to be aware of the Otezla tender and swollen joint data through 5 years. Consider open-label extension study limitations when interpreting results. The open-label extension was not blinded, not controlled, and included inherent self-selection bias. ^1-3

Overall, from weeks 52 to 260, a total of 156 patients (30%) discontinued during the study, of which 33 patients (6.3%) discontinued due to adverse events. I have seen a lot of appropriate patients stay on Otezla for numerous years. ^1-3

References: 1. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 2. Data on file, Amgen Inc. 3. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

In fact, my good friend’s daughter is now a family-medicine physician locally, I diagnosed her with active psoriatic arthritis. She’s now been on Otezla for a few years, and I’ve seen her tender and swollen joints improve, and in fact I’ve just renewed her Otezla prescription.

That’s been my experience with many of my other patients that have been on this medicine. Long-term efficacy has been studied. The data is there.

I also tell my patients that Otezla’s safety has been studied extensively. That’s usually the first thing they want to discuss.

As you can see on screen, safety was also evaluated in the PALACE 1-3 studies. The most common adverse reactions (≥5%) were diarrhea, nausea, and headache through week 16. ¹

Reference: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

In addition, Otezla demonstrated a consistent long-term safety profile through 5 years of exposure in the PALACE 1-3 clinical studies, with the most common adverse reactions being diarrhea, nausea, and headache. ^1,2

The Otezla exposure period in each column includes all data while patients were exposed to Otezla during the interval, relative to the start of Otezla. ^1,2

References: 1. Data on file, Amgen Inc. 2. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118.

Another very important point is that Otezla is the first medicine that I have ever prescribed where the label does not require me to check labs at baseline or during treatment. That’s critical.

I prescribe Otezla as a first-line therapy when either NSAIDs or topicals are not enough for my PsA and PsO patients, respectively. I like to be able to use something that’s FDA approved.

It’s a good medication to start with. And a good medication potentially to stay with, because you get proven efficacy, along with an established safety profile…and FDA approval.

If you ask me to summarize my experience with Otezla, I can make that very simple. It’s the first oral medication indicated for psoriasis and psoriatic arthritis, with no label-required lab monitoring.

I look forward to many more years of helping appropriate patients discover whether Otezla can help them.

cDAPSA, clinical Disease Activity for Psoriatic Arthritis; PDE4, phosphodiesterase-4.

Billing and Coding

FAQs

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla/OTEZLA XR 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/OTEZLA XR and institute appropriate therapy

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla/Otezla XR 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/Otezla
XR 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/Otezla XR
dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
Depression: Carefully weigh the risks and benefits of treatment with Otezla/Otezla XR for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla/Otezla XR. 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 adult 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 in adult patients, 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/Otezla XR
- Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of adult 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 adult patients treated with Otezla compared to 1% (3/382) of patients treated with placebo. Body weight loss of 5%-10% occurred in 12% (19/163) of pediatric patients with moderate to severe plaque psoriasis treated with Otezla compared to 2.5% (2/80) with placebo. Body weight loss of ≥10% occurred in 1% (1/163) of pediatric patients treated with Otezla twice daily compared to 0% (0/80) of patients with placebo. Closely monitor growth (height and weight) in Otezla/Otezla XR-treated pediatric patients. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted
- Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of adult 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 co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla/Otezla XR efficacy may occur. Concomitant use of Otezla/Otezla XR 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 adult patients with mild to moderate plaque psoriasis and pediatric patients with moderate to severe plaque psoriasis was consistent with the safety profile 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

Advise pregnant women of the potential risk of fetal loss

INDICATIONS

Otezla/Otezla XR 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 pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
Otezla XR is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 50 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
Otezla is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis
Otezla XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis
Otezla/Otezla XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease

Please click here for the full Prescribing Information.

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VIDEO HUB

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Dermatology

MECHANISM OF ACTION IN PLAQUE PSORIASIS

OTEZLA IS AN ORAL THERAPY WITH MODERATE TO SEVERE SCALP DATA IN ITS LABEL ¹

Mechanism of Action in Plaque Psoriasis, click here

Otezla is an Oral Therapy with Moderate to Severe Scalp Data in Its Label, click here

Rheumatology

A TREAT-TO-TARGET APPROACH FOR PATIENTS WITH PSORIATIC ARTHRITIS USING cDAPSA

OTEZLA IS THE FIRST & ONLY FDA-APPROVED THERAPY FOR ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHÇET'S DISEASE

OTEZLA IS AN ORAL TREATMENT OPTION FOR USE IN PSORIATIC ARTHRITIS PATIENTS ¹