*Otezla® is contraindicated in pregnancy. Pregnancy should be excluded before treatment can be initiated. Women of childbearing potential should use an effective method of contraception during treatment. Otezla® should not be used during breast feeding.

OTEZLA® delivered significant improvements in PASI vs placebo, with responses sustained up to 1 year*3,4

PASI improvements maintained at Week 52 in patients on OTEZLA® who were PASI responders at Week 32†3,4
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*OTEZLA® patients had a mean PASI of 18.7 and 18.9 (ESTEEM 1 and 2).3,4
†PASI responder was defined as PASI-75 (ESTEEM 1) or PASI-50 (ESTEEM 2) response at Week 32.3,4

Achieve control of the key domains in each patient, while considering disease activity, patient perspective and comorbidities5

OTEZLA® delivered significant improvements in ACR20 vs placebo, with responses sustained over 5 years7

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OTEZLA® met the primary efficacy endpoint of the proportion achieving ACR20 at Week 16 vs placebo in the PALACE 1-3 pivotal studies, 8-10 PALACE 1: 39.8% (N=161) OTEZLA® 3O MG BID vs 19.4% (n=162) OTEZIA® 30 mg BID vs 18.9% (n=159) placebo (p=0.006): 41% (n=167) OTEZLA® 30 mg BID VS 18% (n=169) placebo (p<0.0001)10

ACR, American College of Rheumatology: ACR20, 20% improvement in modified American College of Rheumatology response criteria; ACR50, 50% improvement in modified American College of Rheumatology response criteria; ACR70, 70% improvement in modified American College of Rheumatology response criteria; BID, twice daily; DMARD, disease-modifying antirheumatic drug; PASI, Psoriasis Area and Severity Index; PASI, Psoriasis Area and Severity index; PASI-50, 50% reduction from baseline in target Psoriasis Area and Severity Index; PASI-75, 75% reduction from baseline in target Psoriasis Area and Severity Index, PSA, psoriatic arthritis; R, randomisation ratio; RCT, randomised controlled trial.

  • References
    1. Augustin M. et al. J Eur Acad Dermatol Venereol. 2021;35:123-134
    2. Rich P, et al. J Am Acad Dermatol. 2016:74:134-142:
    3. Papp K, et al. J Am Acad Dermatol. 2015;73(1):37-49;
    4. Paul C, et al. Br J Dermatol, 2015:173(6): 1387-1399
    5. Coates LC, et al. Br J Dermatol. 2016:174(6):1174-1178;
    6. Bagel J, Schwartzman S. Am J Clin Dermatol, 2018:19(6):839-852
    7. Kavanaugh A, et al. Arthritis Res Ther. 2019;21:118
    8. Kavanaugh A. et al Ann Rheum Dis 2014;73(6):1020-6
    9. Cutolo M. et al. The Journal of Rheumatology 2016; 43:9;1724-1734
    10. Edwards CJ, et al. Ann Rheum Dis 2016;75:1065–1073
GBR-407-1224-80009 | February 2025
  • Adverse Event Reporting Information
    Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Amgen Limited on +44 (0) 1223 436441.