Otezla Is the Only Oral Therapy with Scalp Data in Its Label 2
Dr. Sulich: Hello! I’m Dr. Andrew Sulich. Let’s review the PALACE 1-3 results and cDAPSA post-hoc analysis in adult patients with active psoriatic arthritis, which identified patients who are most likely to achieve treatment targets. 1-4 Otezla® , apremilast, is an oral, nonbiologic PDE4 inhibitor indicated for the treatment of adult patients with active psoriatic arthritis. 5 It is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation. 1493 total patients were involved in PALACE 1-3 trials. 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 an American College of Rheumatology criteria for an at least 20% improvement, or ACR20 response, at week 16. 5,6 Significantly more patients receiving Otezla achieved ACR20 response compared with the placebo at week 16 in PALACE 1. Similar results were seen in PALACE 2 and 3. 5 At week 16, the ACR50 and ACR70 responses did not reach significance in the PALACE 1-3 trials. 5 Pooled PALACE 1-3 ACR20, ACR50, and ACR70 responses in patients at week 52 were 55%, 26%, and 12%, respectively. 6 This is exploratory and has not been adjusted for multiple comparisons. Otezla has an established safety profile. In the PALACE 1-3 trials, the most common adverse reactions in at least 5% of patients receiving Otezla through week 16 were: diarrhea, nausea, and headache. 5 Treatment was discontinued due to any adverse reactions in 4.6% of Otezla treated patients and 1.2% of placebo treated patients. 5 Postmarketing reports of severe diarrhea, nausea, and vomiting have been associated with the use of Otezla. In some cases patients were hospitalized. Monitor patients who are more susceptible to complications of diarrhea or vomiting. 5 The most common adverse reactions that occurred at week 52 in at least 5% of patients were consistent with those observed through week 52. 6 Let’s dive into the cDAPSA post-hoc analysis data from the PALACE 1-3 trials. cDAPSA was retrospectively evaluated in 494 patients receiving Otezla 30 mg twice daily who had undergone randomization who had cDAPSA components available at baseline. 4 Outcome measures included the probability of achieving cDAPSA treatment targets, defined as achieving either remission or low disease activity, LDA, at week 52. 4 Let’s first look at the cDAPSA longitudinal assessment of disease activity through week 52. This assessment retrospectively analyzed pooled patients within each cDAPSA disease activity category at week 52 to determine the mean cDAPSA scores at baseline. 4 We can see that those who achieved treatment targets at week 52 had lower cDAPSA scores at baseline versus patients who did not. 4 Now, let’s discuss the percentage of patients who achieved cDAPSA treatment targets at week 52 according to their disease activity at baseline. Almost half of the patients with moderate disease activity at baseline achieved treatment targets of remission or LDA by week 52… 4 and approximately 37% achieved treatment targets at week 16. 4 We are now approaching the end of this video. Before I summarize the key take-home messages, let’s listen to the important safety information for Otezla.
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. 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. 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. Please see the Full Prescribing Information for Otezla provided on OtezlaPro.com.
Dr. Sulich: As noted previously, this post hoc analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn. In conclusion, this short video highlighted Otezla data from the PALACE 1-3 trials and a cDAPSA post-hoc analysis that identified which patients were likely to achieve treatment targets based on disease activity at baseline. 4 Thank you for listening!
References: 1. Kavanaugh, et al. Ann Rheum Dis 2014;73:1020-1026. 2. Cutolo, et al. J Rheumatol. 2016;43:9. 3. Edwards, et al. Ann Rheum Dis. 2016;75:1065-1073. 4. Mease, et al. Arthritis Care Res (Hoboken). 2020;72:814-821. 5. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 6. Kavanaugh, et al. Arthritis Res Ther. 2019;21:118.
