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    TNF alfpha inhibitor safety, efficacy data grows

    Study data upholds long-term use for patients

    Dr. FernandezThe growing body of safety and efficacy data behind tumor necrosis factor alpha (TNFa) inhibitors is making it easier to allay patients' concerns, according to an expert.

    Anthony P. Fernandez, M.D., Ph.D., says, "One of the most common questions I get from patients about biologics is, are they safe to take for a long period of time? The beauty of TNF alpha inhibitors is that we are accumulating these long-term data that increasingly allow us to say yes." Dr. Fernandez is director of medical dermatology in the departments of dermatology and pathology at Cleveland Clinic.

    Although long-term studies and observational registries have important limitations, he says, the following findings should also make dermatologists more comfortable prescribing TNF inhibitors:

    ·      Infliximab – At least two years' follow-up data show that most patients maintain their responses in terms of psoriasis area and severity index (PASI) 50, 75 and 90,1 says Dr. Fernandez. "Perhaps more importantly, the adverse effect profile has been similar to what we have seen in the clinical trials."

    ·      Etanercept – The “Observational PostMarketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis” (OBSERVE-5) registry shows efficacy lasting five years in some patients. Dr. Fernandez added, "There has been no association with significantly increased adverse events. The observed rates of malignancies including lymphomas and nonmelanoma skin cancers have not been higher than expected."2

    ·      Adalimumab – The “Phase 3 Randomized Controlled Evaluation of Adalimumab Every Other Week Dosing in Moderate to Severe Psoriasis Trial” (REVEAL) included a three year open-label extension showing that patients who maintained PASI 75 through the first 33 weeks were very likely to maintain these results.3 The 10-year, “Post-Marketing, Observational Study to Assess Long Term Safety of Humira (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis” (ESPRIT) registry shows similar results out to seven years, with no new safety signals.4 "In fact, the number of treatment-emergent deaths in the registry has been below expected for the comparable general population."

    ·      “Psoriasis Longitudinal Assessment and Registry” (PSOLAR) data reflect low rates of serious infections and no statistically significant increases in malignancy risks for biologics including TNF inhibitors, says Dr. Fernandez. Among 11,466 patients receiving biologic therapies, methotrexate and other treatments, the rate of serious infections was 1.47 to 2.49 per 100 patient-years. "Adalimumab and infliximab showed slightly higher risk versus non-methotrexate and non-biologic therapies,"5 says Dr. Fernandez. Age- and gender-adjusted cumulative malignancy rates were comparable among all treatment groups, he added, and the most commonly reported malignancies mirrored those found in the general population.6

    Disclosures: Dr. Fernandez has been a speaker, consultant and researcher for AbbVie. He has also been a speaker for Celgene and a researcher for Roche, Xoma, Corrona and Mallinckrodt.Disclosures: 


    1. Shear NHHartmann MToledo-Bahena M, et al. Long-term efficacy and safety of infliximab maintenance therapy in patients with plaque-type psoriasis in real-world practice. Br J Dermatol. 2014;171(3):631-41.

    2. Kimball ABRothman KJKricorian G, et al. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results. J Am Acad Dermatol. 2015;72(1):115-22.

    3.  Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012;66(2):241-51.

    4. Kerdel A, Menter A, Wu JJ, et al. Seven-year interim results from the ESPRIT 10-year postmarketing surveillance registry of adalimumab for moderate-to-severe psoriasis. P2037. 25th Annual EADV Congress. September 28-October 2, 2016. Vienna.

    5. Fiorentino D, Lebwohl M, Ho V, et al. Current status of observations of malignancies in the Psoriasis Longitudinal Assessment and Registry (PSOLAR) Study. P3207. 75th Annual American Academy of Dermatology Meeting. March 3-7, 2017. Orlando.

    6. Kalb REFiorentino DFLebwohl MG, et al. Risk of serious infection with biologic and systemic treatment of psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). JAMA Dermatol. 2015;151(9):961-9. 

    John Jesitus
    John Jesitus is a medical writer based in Westminster, CO.


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