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Role of biologics: anti-TNFs

compared the efficacy of the treatment of IFX in combination with MTX with MTX alone in monotherapy. A PASI 75 response was achieved at week 16 in 97.1% of patients treated with the combination and 54.3% of patients treated with methotrexate alone.25 In some cases, the addition of low doses of MTX (7.5–10mg/week) can be considered a good alternative to reduce the formation of antibodies anti-IFX and keep the efficacy of IFX over time while minimising the potential for MTX-associated toxicity.26 Regarding safety, the most common adverse effects of IFX are infusion reactions (often associated with anti-IFX antibody formation), which have been described in up to 20% of patients, followed by infections. Infusion reactions may be immediate or delayed; immediate reactions occur during the infusion or in the first hours following its termination and consist of the apparition of urticarial rash with pruritus, fever, headache, backache, hypotension or hypertension, and dyspnea with bronchospasm. In most cases, the reaction is mild and can be easily controlled with the administration of antihistamines, allowing reinitiation of the infusion, albeit at an initially low flow. In severe cases, the use of intravenous steroids, epinephrine or bronchodilators may be required. Delayed infusion reactions appear from 24 hours to 12 days after the infusion, and clinically consist of the presence of arthralgia, fever, lymphadenopathy and skin eruption, with associated pruritus, headache and dyspnea. This type of reaction is more common in patients with high levels of anti-IFX antibodies and has been reported to appear when the patient restarts the treatment after having stopped it previously. Concomitant use of low doses of MTX may be useful in reducing the development of these neutralising antibodies.27 The most commonly reported infections are upper airway infections, followed by bacterial skin, gynaecological and urinary infections. Influenza and varicella zoster infections have also been reported more commonly in registries of patients treated with anti-TNF agents, and especially IFX or ADA. The risk of developing active tuberculosis (usually by reactivation of latent infection) is four to five times more frequent in patients treated with IFX, and usually happens during the first six months following the initiation of treatment. In all patients, it is important to rule out the presence of latent and active tuberculosis and start chemoprophylaxis or anti-tuberculous treatment before the treatment with

biologic agents.28

Other viral infections,

such as hepatitis B and C and HIV infection, should also be screened prior to the start of treatment. l

References 1. Sivamani RK et al. Biologic therapies in the treatment of psoriasis: a comprehensive evidence-based basic science and clinical review and a practical guide to tuberculosis monitoring. Clin Rev Allergy Immunol 2013;44(2):121–40.

2. Jamnitski A et al. The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept. Ann Rheum Dis 2011;70(2):284–8.

3. Goffe B, Cather JC. Etanercept: An overview. J Am Acad Dermatol 2003;49(2Suppl):S105–11.

4. Paller AS et al. Long-term etanercept in pediatric patients with plaque psoriasis. J Am Acad Dermatol 2010;63(5):762–8.

5. Leonardi CL et al. Etanercept Psoriasis Study Group. Etanercept as monotherapy in patients with psoriasis N Engl J Med 2003;20;349(21):2014–22.

6. Luger TA et al. Sustained improvement in joint pain and nail symptoms with etanercept therapy in patients with moderate-to-severe psoriasis. J Eur Acad Dermatol Venereol 2009;23(8):896–904.

7. Kasche A et al. Severe psoriasis pustulosa palmaris et plantaris (Barber-Königsbeck) treated successfully with soluble tumour necrosis factor receptor fusion protein (etanercept). J Eur Acad Dermatol Venereol 2007;21(2):255–7.

8. Esposito M et al. Treatment of erythrodermic psoriasis with etanercept. Br J Dermatol 2006;155(1):156–9.

9. Kircik L et al. Unite Study Group. Utilization of narrow-band ultraviolet light B therapy and etanercept for the treatment of psoriasis (UNITE): efficacy, safety, and patient-reported outcomes. J Drugs Dermatol 2008;7(3):245–53.

10. Driessen RJ, van de Kerkhof PC, de Jong EM. Etanercept combined with methotrexate for high-need psoriasis. Br J Dermatol 2008;159(2):460–3.

11. Gisondi P et al. Combining etanercept and acitretin in the therapy of chronic plaque psoriasis: a 24-week, randomized, controlled, investigator-blinded pilot trial. Br J Dermatol 2008;158:1345–9.

12. Weisman MH et al. A placebo-controlled, randomized, double-blinded study evaluating the safety of etanercept in patients with rheumatoid arthritis and concomitant comorbid diseases. Rheumatology (Oxford) 2007;46(7):1122–5.

13. Gordon KB et al. Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study. J Am Acad Dermatol 2006;55(4):598–606.

14. Krieckaert CL, Nurmohamed MT, Wolbink GJ. Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis patients

in a dose dependent manner. Ann Rheum Dis 2012;71:1914–5.

15. Gordon K et al. 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.

16. Sinagra E, Perricone G, Romano C, Cottone M. Heart failure and anti tumor necrosis factor-alpha in systemic chronic inflammatory diseases. Eur J Intern Med 2013;24(5):385–92.

17. Gottlieb AB et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol 2004;51(4):534–42.

18. Reich K et al. EXPRESS study investigators. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005;15– 21;366(9494):1367–74.

19. Chaudhari U et al. Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial. Lancet 2001;357(9271):1842–7.

20. Reich K et al. Improvement in quality of life with infliximab induction and maintenance therapy in patients with moderate-to-severe psoriasis: a randomized controlled trial. Br J Dermatol 2006;154(6):1161–8.

21. Menter A et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol 2007;56(1):31.e1–15.

22. Rich P et al. Baseline nail disease in patients with moderate to severe psoriasis and response to treatment with infliximab during 1 year. J Am Acad Dermatol 2008;58(2):224–31.

23. Lewis TG, Tuchinda C, Lim HW, Wong HK. Life-threatening pustular and erythrodermic psoriasis responding to infliximab. J Drugs Dermatol 2006;5(6):546–8.

24. Lisby S, Gniadecki R. Infliximab (Remicade) for acute, severe pustular and erythrodermic psoriasis. Acta Derm Venereol 2004;84(3):247–8.

25. Baranauskaite A et al. RESPOND investigators. Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naïve patients: the RESPOND study. Ann Rheum Dis 2012;71(4):541–8.

26. Warren RB, Brown BC, Carmichael AJ, Griffiths CE. Long-term control of recalcitrant psoriasis with combination infliximab and methotrexate. Clin Exp Dermatol 2009;34(3):415–6.

27. Han PD, Cohen RD. Managing immunogenic responses to infliximab: treatment implications for patients with Crohn’s disease. Drugs 2004;64(16):1767–77.

28. Winthrop KL. Update on tuberculosis and other opportunistic infections associated with drugs blocking tumour necrosis factor a. Ann Rheum Dis 2005;64 Suppl 4:iv29–30.



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