RESULTS
the way
PATIENTS WANT THEM1-6
Otezla billboard

OTEZLA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA)1

OTEZLA, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy1

The importance of choosing the right patient for OTEZLA

Psoriasis

When conventional systemic therapy fails, how can you give your patients results the way they want them?


PASI scores, high impact areas and lifestyle should all be taken into account when choosing a treatment7

Skin psoriasis

  • Even patients with a PASI of 10-15 report a substantial impact on their quality of life8

Busy lifestyle

  • Employment
  • Family responsibilities
  • Travelling

High impact areas

  • Scalp, nail and palmoplantar involvement are associated with reduced quality of life7,9

Psoriatic Arthritis

When DMARD therapy fails, how can you give your patients results the way they want them?


Joint involvement, disease and burden and lifestyle should all be considered when choosing a treatment10,11

Peripheral arthritis

  • Moderate psoriatic arthritis defined as a cDAPSA score of <13 to ≤2712
  • Even patients with few affected joints report high disease burden13

Skin & nail psoriasis

  • Constitute nearly half of patient-reported disease burden14

Dactylitis & enthesitis

  • Associated with higher levels of physical impairment15

Busy lifestyle

  • Employment
  • Family responsibilities
  • Travelling

OTEZLA: broad and sustained efficacy in psoriasis1,16 and psoriatic arthritis1,17

Psoriasis

OTEZLA met the primary endpoint of the pivotal trials: PASI-75 response vs placebo at 16 weeks1

  • ESTEEM 1: 33.1% (n=562) vs 5.3% (n-282); ESTEEM 2: 28.8% (n=274) vs 5.8% (n=137)1*

The APPRECIATE study evaluated the real-world experience with OTEZLA across Europe, including 126 patients from 16 dermatology centres in the UK and Ireland2,18-19

UK and Ireland sub-analysis:

After 6 (±1) months, patients reported that OTEZLA helped them to:2**

80%

Regain control of the disease

84%

Lead a normal life

80%

Be itch-free

60%

of patients had a PASI-75 response (n=37/62)18

Mean baseline PASI of OTEZLA patients: 12.5 (±7.1)2

*P<0.0001.

**Patients who achieved benefit as defined by answer of "somewhat","moderately","quite", or "very" on the Patient Benefit Questionnaire; "not at all", and "does not apply to me" are other possible answers. Missing and "does not apply to me" data excluded; n=103 to 109

PASI: Psoriasis Area and Severity Index; RCT: randomised controlled trial; RWE: real-world evidence

Psoriatic Arthritis

OTEZLA met the primary endpoint of the pivotal trials:

ACR 20 response vs placebo at 16 weeks1

  • Pooled data from PALACE 1-3: 37.0% (n=497) vs 18.8% (n=496)

cDAPSA scores were calculated for patients from the pivotal trials by summing SJC + TJC + PAP + PtGA12**

Probability of achieving treatment target (REM or LDA) at 1 year12**✝

Mean SJC of 5.5 and mean TJC of 8.5 at baseline

(in moderate patients who achieved remission/low disease activity at Week 52)12

*P<0.0001.

**Subjects enrolled in PALACE 1-3 who were randomized to OTEZLA 30 mg BID with cDAPSA scores available at baseline (n=494).

REM: cDAPSA score of ±4.

ACR: American College of Rheumatology; cDAPSA: Clinical Disease Activity Index for Psoriatic Arthritis; LDA: low disease activity; PAP: Patient’s Assessment of Pain; PtGA: Patient’s Global Assessment of Disease Activity; PsA: psoriatic arthritis; RCT: randomised controlled trial; REM: remission; SJC: swollen joint count; TJC: tender joint count.

OTEZLA: the reassurance of a long-term safety and tolerability profile20,21

In the OTEZLA pivotal trials, the majority of adverse events (AEs) were mild or moderate and transient1

  • The most commonly reported AEs in Phase III clinical studies (psoriasis or psoriatic arthritis) have been gastrointestinal disorders including diarrhoea (15.7%) and nausea (13.9%)1
  • 0.3% of diarrhoea and 0.3% of nausea were reported as being severe1
  • The other most commonly reported adverse reactions included upper respiratory tract infections (8.4%), headache (7.9%), and tension headache (7.2%)1

Long-term follow-up indicated generally no increase in the incidence or severity of AEs20

No increased risk of serious or opportunistic infections, malignancies or major adverse cardiac events vs placebo22 or with long-term exposure20

For special warnings and precautions on psychiatric disorders, gastrointestinal disorders, severe renal impairment, and underweight patients, please refer to the OTEZLA Summary of Product Characteristics.

OTEZLA: simple for you, convenient for patients23

Oral therapy with no label requirement for TB screening (before or during treatment) or routine treatment-specific laboratory monitoring1

Image of the Otezla pack

Get patients started with an easy-to-use treatment initiation pack

  • 5-day titration period24
  • No re-titration required after initial titration24**

Continue with convenient maintenance dosing

  • One 30 mg tablet twice daily1†
  • Can be taken with or without food1

OTEZLA MOA in Psoriasis

UK-I&I170079(2)

November 2018

OTEZLA MOA in Psoriatic Arthritis

UK-I&I170011a(2)

November 2018

Guidance

Guidance in Psoriasis

  • Apremilast (OTEZLA) is recommended as an option for treating chronic plaque psoriasis in adults whose disease has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and ultraviolet-A light), or when these treatments are contraindicated or not tolerated.25

    Full Guidance
  • Apremilast (OTEZLA) is accepted for use in adult patients for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or PUVA.26

    Full Guidance
  • Apremilast (OTEZLA) has been approved for reimbursement for the treatment of moderate to severe chronic plaque psoriasis in adult patients who have failed to respond to or who have a contraindication to, or are intolerant to systemic non-biologic therapies including cyclosporine, methotrexate or PUVA.27

    Full Guidance

View how apremilast (OTEZLA) fits into the NICE pathway treatment selection for psoriasis here28

National Institute for Health and Care Excellence (2017) Apremilast for treating moderate to severe plaque psoriasis. Available from: https://www.nice.org.uk/guidance/ta419. NICE has not checked the use of its content in this product to confirm that it accurately reflects the NICE publication from which it is taken.

Guidance in Psoriatic Arthritis

  • Apremilast (OTEZLA), alone or in combination with disease-modifying antirheumatic drugs (DMARDs), is recommended as an option for treating active psoriatic arthritis in adults.29

    Full Guidance
  • Apremilast (OTEZLA) is accepted for restricted use in adult patients with active psoriatic arthritis who have had an inadequate response with at least two prior DMARD therapies or who are intolerant to such therapies.30

    Full Guidance
  • Apremilast (OTEZLA), alone or in combination with DMARDs, has been approved for reimbursement for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.31

    Full Guidance

View how apremilast (OTEZLA) fits into the NICE pathway treatment selection for psoriatic arthritis here32

National Institute for Health and Care Excellence (2017) Managing peripheral spondyloarthritis in adults. Available from: https://www.nice.org.uk/guidance/ta433. NICE has not checked the use of its content in this product to confirm that it accurately reflects the NICE publication from which it is taken.


HSE: Health Service Executive; NICE: National Institute for Health and Care Excellence; SMC: Scottish Medicines Consortium

OTEZLA is a targeted, oral therapy that offers:

  • Broad and sustained efficacy in psoriasis1,16 and psoriatic arthritis1,17
  • The reassurance of a long-term safety and tolerability profile20,21
  • Simplicity for you. Convenience for your patients1,23

References:

  1. OTEZLA (apremilast) 30 mg tablets. Summary of Product Characteristics. Celgene Europe Ltd. BV
  2. Shams K, et al. Poster presented at: the 98th Annual Meeting of the British Association of Dermatologists (BAD), 3-5 July 2018; Edinburgh, UK (P014).
  3. Eliasson L, et al. Patient Prefer Adherence. 2017;11:353-362.
  4. Lebwohl MG, et al. J Am Acad Dermatol. 2014;70(5):871-881.
  5. McInnes I, et al. Ann Rheum Dis. 2018;77:1588-1589.
  6. Mease P, et al. Ann Rheum Dis. 2018;77:201-202.
  7. World Health Organization. Global report on Psoriasis 2016. Available at: http://apps.who.int/iris/handle/10665/204417 (accessed July 2019)
  8. Geale K, et al. Health Qual Life Outcomes. 2017;15:151.
  9. Chung J, et al. J Am Acad Dermatol. 2014;71(4):623-632
  10. Gossec L, et al. Ann Rheum Dis. 2016;75(3):499-510.
  11. Coates LC, et al. Br J Dermatol. 2016;174(6):1174-1178.
  12. Mease PJ, et al. Data presented at: the Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP); October 19-24, 2018; Chicago, IL (2570).
  13. Huscher D, et al. Data presented at: the Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP), 6-11 November 2015; San Francisco, CA (#679).
  14. Dandorfer, SW et al. Semin Arthritis Rheum. 2012;42(1):32-41.
  15. Kavanaugh A, et al. Rheumatol Ther. 2016;3(1):91-102.
  16. Papp K, et al. J Am Acad Dermatol. 2015;73(1):37–49.
  17. Kavanaugh A, et al. Ann Rheum Dis. 2014;73(6):1020-1026.
  18. Kleyn CE, et al. Poster presented at: the 98th Annual Meeting of the British Association of Dermatologists (BAD), 3-5 July 2018; Edinburgh, UK (P085).
  19. ClinicalTrials.gov (NCT02740218). Available at: https://clinicaltrials.gov/ct2/show/NCT02740218?term=NCT02740218&rank=1 (accessed July 2019)
  20. Mease P.J. et al Presented at: the 2017 ACR/ARHP Annual Meeting; November 3–8, 2017; San Diego, CA. 604
  21. Crowley J, et al. J Am Acad Dermatol. 2017;77(2):310–317.
  22. Mease PJ, et al. Poster presented at: the Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP), 26-30 October 2013; San Diego, CA (#310).
  23. Torres T & Puig L. Am J Clin Dermatol. 2018;19(1):23-32.
  24. OTEZLA (apremilast) 10mg, 20mg, 30mg treatment initiation pack. Summary of Product Characteristics. Celgene Europe Ltd. BV
  25. NICE: Technology appraisal guidance 419: Apremilast for treating moderate to severe plaque psoriasis. 23 November 2016. Available at: www.nice.org.uk/guidance/ta419 (accessed July 2019).
  26. SMC Advice: Apremilast (OTEZLA) plaque psoriasis. 8 June 2015. Available at: https://www.scottishmedicines.org.uk/medicines-advice/apremilast-otezla-plaque-psoriasis-fullsubmission-105215/ (accessed July 2019).
  27. HSE: Apremilast (OTEZLA) for moderate to severe chronic plaque psoriasis. October 2017. Available at: http://www.ncpe.ie/drugs/apremilast-otezla-for-moderate-to-severe-chronic-plaque-psoriasis/ (accessed July 2019).
  28. NICE Pathways. 2018. Systemic non-biological therapy for psoriasis. Available at: https://pathways.nice.org.uk/pathways/psoriasis#content=view-node%3Anodes-apremilast &path=view%3A/pathways/psoriasis/systemic-non-biological-therapy-for-psoriasis.xml (accessed July 2019).
  29. NICE: Technology appraisal guidance 433: Apremilast for treating active psoriatic arthritis. 22 February 2017.Available at: www.nice.org.uk/guidance/ta433 (accessed July 2019).
  30. SMC Advice: apremilast (OTEZLA) psoriatic arthritis. 8 June 2015. Available at: https://www.scottishmedicines.org.uk/medicines-advice/apremilast-otezla-psoriatic-arthritis-fullsubmission-105315/ (accessed July 2019).
  31. HSE: Apremilast (OTEZLA) for psoriatic arthritis. October 2017. Available at: http://www.ncpe.ie/drugs/apremilast-otezla-for-psoriatic-arthritis/ (accessed July 2019).
  32. NICE Pathways. 2018. Managing peripheral spondyloarthritis in adults. Available from: https://pathways.nice.org.uk/pathways/spondyloarthritis#path=view%3A/pathways/spondyloarthritis/managing-peripheral-spondyloarthritis-in-adults.xml&content=view-node%3Anodes-choice-of-non-biological-therapy . (accessed July 2019).

Prescribing Information: OTEZLA®▼ (apremilast) 10mg, 20mg and 30mg film coated-tablets. Refer to the Summary of Product Characteristics (SPC) before prescribing Presentation: 10mg, 20mg and 30mg film coated-tablets. Indications: Psoriatic arthritis: OTEZLA®, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. Psoriasis: OTEZLA® is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA). Dosage and administration: Treatment with OTEZLA® should be initiated by specialists experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis. The recommended dose of OTEZLA® is 30mg twice daily taken orally, morning and evening, approximately 12 hours apart, with no food restrictions. The film-coated tablets should be swallowed whole. To reduce risk of gastrointestinal symptoms, an initial dose titration is required per the following schedule: Day 1: 10mg in the AM; Day 2: 10mg in the AM and 10 mg in the PM; Day 3: 10mg in the AM and 20mg in the PM; Day 4: 20mg in the AM and 20mg in the PM; Day 5: 20mg in the AM and 30mg in the evening; Day 6 and thereafter: 30mg twice daily. No re-titration is required after initial titration. If patients miss a dose, the next dose should be taken as soon as possible. If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time. During pivotal trials the greatest improvement was observed within the first 24 weeks of treatment. If a patient shows no evidence of therapeutic benefit after 24 weeks, treatment should be reconsidered. The patient's response to treatment should be evaluated on a regular basis. Special populations: Elderly patients: No dose adjustment is required for this patient population. Patients with renal impairment: No dose adjustment is needed in patients with mild and moderate renal impairment. The dose of OTEZLA® should be reduced to 30mg once daily in patients with severe renal impairment (creatinine clearance of less than 30mL per minute estimated by the Cockcroft-Gault equation). For initial dose titration in this group, it is recommended that OTEZLA® is titrated using only the AM doses and the evening doses be skipped. Patients with hepatic impairment: No dose adjustment is necessary for patients with hepatic impairment Paediatric population: The safety and efficacy of OTEZLA® in children aged 0 to 17 years have not been established. No data is available. Contraindications: Hypersensitivity to the active substance(s) or to any of the excipients. OTEZLA® is contraindicated in pregnancy. Pregnancy should be excluded before treatment can be initiated. Special warnings and precautions: Patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Severe diarrhoea, nausea, and vomiting associated with the use of Otezla has been reported. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older may be at a higher risk of complications. Discontinuation of treatment may be necessary. OTEZLA® is associated with an increased risk of psychiatric disorders such as insomnia and depression. Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression. The risks and benefits of starting or continuing treatment with OTEZLA® should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Patients and caregivers should be instructed to notify the prescriber of any changes in behavior or mood and of any suicidal ideation. If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with OTEZLA®. OTEZLA® should be dose reduced to 30mg once daily in patients with severe renal impairment. OTEZLA® may cause weight loss. Patients who are underweight at the start of treatment should have their body weight monitored regularly. In the event of unexplained and clinically significant weight loss, these patients should be evaluated by a medical practitioner and discontinuation of treatment should be considered. Women of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment. OTEZLA® should not be used during breast-feeding. No fertility data is available in humans. Interactions: Co-administration of strong cytochrome P450 3A4 (CYP3A4) enzyme inducer, rifampicin, resulted in a reduction of systemic exposure of OTEZLA®, which may result in a loss of efficacy of OTEZLA®. Therefore, the use of strong CYP3A4 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin and St. John’s Wort) with OTEZLA® is not recommended. In clinical studies, OTEZLA® has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and salicylic acid scalp preparations) and UVB phototherapy. There was no clinically meaningful drug-drug interaction between ketoconazole and OTEZLA®. OTEZLA® can be co-administered with a potent CYP3A4 inhibitor such as ketoconazole. There was no pharmacokinetic drug-drug interaction between OTEZLA® and methotrexate in psoriatic arthritis patients. OTEZLA® can be co-administered with methotrexate. There was no pharmacokinetic drug-drug interaction between OTEZLA® and oral contraceptives containing ethinyl estradiol and norgestimate. OTEZLA® can be co-administered with oral contraceptives. Side effects: The most commonly reported adverse reactions in Phase III clinical studies have been gastrointestinal disorders including diarrhoea and nausea. The other most commonly reported adverse reactions included upper respiratory tract infections, headache, and tension headache. The most common adverse reactions leading to discontinuation during the first 16 weeks of treatment were diarrhoea, and nausea. The overall incidence of serious adverse reactions was low and did not indicate any specific system organ involvement. Very commonly reported adverse events are listed as: diarrhoea* and nausea*. Common adverse events are listed as: bronchitis, upper respiratory tract infection, nasopharyngitis*, decreased appetite*, insomnia, depression, migraine*, tension headache*, headache*, cough, vomiting*, dyspepsia, frequent bowel movements, upper abdominal pain*, gastroesophageal reflux disease, back pain*, fatigue. Prescribers should consult the summary of product characteristics in relation to other side-effects. Hypersensitivity* and risk of triggering suicide* have also been reported. *At least one of these was reported as serious or could be considered serious NHS list price: £265.18 per 14-day titration pack; £550 per pack of 56 tablets (30mg). Legal category: POM Marketing authorisation numbers: EU/1/14/981/001, EU/1/14/981/002 and EU/1/14/981/003. Marketing authorisation holder: Celgene Europe BV, Winthontlaan 6 N, 3526KV Utrecht, Netherlands. For further information contact: Celgene Ltd, 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom Tel: +44(0)208 831 8300 Date of preparation: July 2018 Approval code: UK-OTZ180094 Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Celgene Drug Safety
Tel: 0808 238 9908
Fax: 0844 801 0468