Biological therapies (immunomodulatory drugs), worsening of psoriasis and rebound effect: new evidence of similitude

Background: Employing the secondary action or adaptative reaction of the organism as therapeutic response, homeopathy uses the treatment by similitude (similia similibus curentur) administering to sick individuals the medicines that caused similar symptoms in healthy individuals. Such homeostatic or paradoxical reaction of the organism is scientifically explained through the rebound effect of drugs, which cause worsening of symptoms after withdrawal of several palliative treatments. Despite promoting an improvement in psoriasis at the beginning of the treatment, modern biological therapies provoke worsening of the psoriasis (rebound psoriasis) after discontinuation of drugs.

Method: Exploratory qualitative review of the literature on the occurrence of the rebound effect with the use of immunomodulatory drugs [T-cell modulating agents and tumor necrosis factor (TNF) inhibitors drugs] in the treatment of psoriasis.

Results: Several researches indicate the rebound effect as the mechanism of worsening of psoriasis with the use of efalizumab causing the suspension of its marketing authorization in 2009, in view of some severe cases. Other studies also have demonstrated the occurrence of rebound psoriasis with the use of alefacept, etanercept and infliximab.

Conclusion: As well as studied in other classes of drugs, the rebound effect of biologic agents supports the principle of similitude (primary action of the drugs followed by secondary action and opposite of the organism).

Keywords

Homeopathy - Law of similars - Action mode of homeopathic remedies - Rebound effect - Paradoxical reaction - Biological therapy - Monoclonal antibodies - TNF antagonists - Psoriasis

• References

• 1 Dudgeon R.E. Lectures on the theory and practice of homoeopathy. New Delhi: B Jain Publishers; 2002 [Reprint edition]. Lecture I.
• 2 Hahnemann S. Essay on a new principle for ascertaining the curative power of drugs, with a few glances at those hitherto employed. Dudgeon R.E. The lesser writings of Samuel Hahnemann. New Delhi: B. Jain Publishers; 1995. [Reprint edition].
• 3 Hahnemann S. Organon of medicine. 6th edn [Translated by William Boericke]. New Delhi: B Jain Publishers; 1991.
• 4 Dudgeon R.E. The lesser writings of Samuel Hahnemann. New Delhi: B. Jain Publishers; 1995. [Reprint edition].
• 5 Teixeira M.Z. Semelhante cura semelhante: o princípio de cura homeopático fundamentado pela racionalidade médica e científica. Like cures like: the homeopathic cure principle based on medical and scientific reason São Paulo: Editorial Petrus; 1998.
• 6 Teixeira M.Z. Similitude in modern pharmacology. Br Homeopath J 1999; 88: 112-120.
• 7 Teixeira M.Z. O princípio da similitude na moderna farmacologia. Similitude in modern pharmacology Rev Homeopat (São Paulo) 64 1–4 1999; 45-58.
• 8 Teixeira M.Z. Evidence of the principle of similitude in modern fatal iatrogenic events. Homeopathy 2006; 95: 229-236.
• 9 Teixeira M.Z. NSAIDs, myocardial infarction, rebound effect and similitude. Homeopathy 2007; 96: 67-68.
• 10 Teixeira M.Z. Bronchodilators, fatal asthma, rebound effect and similitude. Homeopathy 2007; 96: 135-137.
• 11 Teixeira M.Z. Antidepressants, suicidality and rebound effect: evidence of similitude?. Homeopathy 2009; 98: 114-121.
• 12 Teixeira M.Z. Statins withdrawal, vascular complications, rebound effect and similitude. Homeopathy 2010; 99: 255-262.
• 13 Teixeira M.Z. Rebound acid hypersecretion after withdrawal of gastric acid suppressing drugs: new evidence of similitude. Homeopathy 2011; 100: 148-156.
• 14 Teixeira M.Z. Rebound effect of drugs: fatal risk of conventional treatment and pharmacological basis of homeopathic treatment. Int J High Dilution Res 11 (39) 2012; 69-106.
• 15 Teixeira M.Z. El efecto de rebote de las drogas: un riesgo fatal para el tratamiento convencional y una base farmacológica para el tratamiento homeopático. Homeopat Méx 81 (681) 2012; 13-40.
• 16 Teixeira M.Z. Antiresorptive drugs (bisphosphonates), atypical fractures and rebound effect: new evidence of similitude. Homeopathy 2012; 101: 231-242.
• 17 Teixeira M.Z. Immunomodulatory drugs (natalizumab), worsening of multiple sclerosis, rebound effect and similitude. Homeopathy 2013; 102: 215-224.
• 18 Teixeira M.Z. Similia similibus curentur: o princípio de cura homeopático fundamentado na farmacologia moderna. Similia similibus curentur: the homeopathic healing principle based on modern pharmacology Rev Med (São Paulo) 92 (03) 2013; 183-203.
• 19 Teixeira M.Z. Rebound effect of modern drugs: serious adverse event unknown by health professionals. Rev Assoc Med Bras 2013; 59: 629-638.
• 20 Teixeira M.Z. Similitude and rebound effect of drugs: scientific evidence and therapeutic application. Homoeopath Links 27 (02) 2014; 105-107.
• 21 Teixeira M.Z. ‘Paradoxical pharmacology’: therapeutic strategy used by the ‘homeopathic pharmacology’ for more than two centuries. Int J High Dilution Res 13 (48) 2014; 207-223.
• 22 Webster's New World Medical Dictionary. 3^a edn New Jersey: Wiley Publishing; 2008
• 23 Hodding G.C., Jann M., Ackerman I.P. Drug withdrawal syndromes – a literature review. West J Med 1980; 133: 383-391.
• 24 Wolfe R.M. Antidepressant withdrawal reactions. Am Fam Physician 1997; 56: 455-462.
• 25 Reidenberg M.M. Drug discontinuation effects are part of the pharmacology of a drug. J Pharmacol Exp Ther 2011; 339: 324-328.
• 26 Rahman M., Alam K., Ahmad M.Z. et al. Classical to current approach for treatment of psoriasis: a review. Endocr Metab Immune Disord Drug Targets 12 (03) 2012; 287-302.
• 27 Leman J., Burden A.D. Sequential use of biologics in the treatment of moderate-to-severe plaque psoriasis. Br J Dermatol 167 (03) 2012; 12-20.
• 28 Papoutsaki M., Costanzo A. Treatment of psoriasis and psoriatic arthritis. BioDrugs 27 (01) 2013; 3-12.
• 29 Pugashetti R., Koo J. Efalizumab discontinuation: a practical strategy. J Dermatol Treat 20 (03) 2009; 132-136.
• 30 Talamonti M., Spallone G., Di Stefani A., Costanzo A., Chimenti S. Efalizumab. Expert Opin Drug Saf 10 (02) 2011; 239-251.
• 31 Jenneck C., Novak N. The safety and efficacy of alefacept in the treatment of chronic plaque psoriasis. Ther Clin Risk Manag 3 (03) 2007; 411-420.
• 32 Tracey D., Klareskog L., Sasso E.H., Salfeld J.G., Tak P.P. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 117 (02) 2008; 244-279.
• 33 Sedger L.M., McDermott M.F. TNF and TNF-receptors: from mediators of cell death and inflammation to therapeutic giants – past, present and future. Cytokine Growth Factor Rev 25 (04) 2014; 453-472.
• 34 Taylor P.C. Pharmacology of TNF blockade in rheumatoid arthritis and other chronic inflammatory diseases. Curr Opin Pharmacol 10 (03) 2010; 308-315.
• 35 Gordon K.B., Feldman S.R., Koo J.Y., Menter A., Rolstad T., Krueger G. Definitions of measures of effect duration for psoriasis treatments. Arch Dermatol 141 (01) 2005; 82-84.
• 36 Bremmer M., Deng A., Gaspari A.A. A mechanism-based classification of dermatologic reactions to biologic agents used in the treatment of cutaneous disease: part 2. Dermatitis 20 (05) 2009; 243-256.
• 37 Sánchez-Regaña M., Dilmé E., Puig L. et al. Adverse reactions during biological therapy for psoriasis: results of a survey of the Spanish Psoriasis Group. Actas Dermosifiliogr 101 (02) 2010; 156-163.
• 38 Kamaria M., Liao W., Koo J.Y. How long does the benefit of biologics last? An update on time to relapse and potential for rebound of biologic agents for psoriasis. Psoriasis Forum 16 (02) 2010; 36-42.
• 39 Genentech, Inc. Biologic License Application. Dermatologic and ophthalmic drugs advisory committee meeting: Raptiva (Efalizumab). Sep 9. 2003. Available at: http://www.fda.gov/ohrms/dockets/ac/03/briefing/3983B1_01_Genentech-Raptiva.pdf [Accessed April 2015].
• 40 Pariser D.M., Gordon K.B., Papp K.A. et al. Clinical efficacy of efalizumab in patients with chronic plaque psoriasis: results from three randomized placebo-controlled phase III trials. Part 1. J Cutan Med Surg 2005; 9: 303-312.
• 41 Dubertret L., Sterry W., Bos J.D. et al. CLEAR Multinational Study Group Clinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: results from a phase III international randomized, placebo-controlled trial. Br J Dermatol 2006; 155: 170-181.
• 42 Sterry W., Stingl G., Langley R.G. et al. CLEAR Multinational Study Group Clinical Experience Acquired with Raptiva (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: results from extended treatment in an international, phase III, placebo-controlled trial. J Dtsch Dermatol Ges 2006; 4: 947-956.
• 43 Leonardi C.L., Papp K.A., Gordon K.B. et al. Efalizumab Study Group Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial. J Am Acad Dermatol 2005; 52: 425-433.
• 44 Gottlieb A.B., Hamilton T., Caro I., Kwon P., Compton P.G., Leonardi C.L. Efalizumab Study Group Long-term continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: updated results from an ongoing trial. J Am Acad Dermatol 54 (04) suppl. 1 2006; S154-S163.
• 45 Carey W., Glazer S., Gottlieb A.B. et al. Relapse, rebound, and psoriasis adverse events: an advisory group report. J Am Acad Dermatol 54 (04) suppl. 1 2006; S171-S181.
• 46 Selenko-Gebauer N., Karlhoer F., Stingl G. Efalizumab in routine use: a clinical experience. Br J Dermatol 156 (02) 2007; 1-6.
• 47 Menter A., Hamilton T.K., Toth D.P. et al. Transitioning patients from efalizumab to alternative psoriasis therapies: findings from an open-label, multicenter, phase IIIb study. Int J Dermatol 2007; 46: 637-648.
• 48 Tsai T.F., Liu M.T., Liao Y.H., Licu D. Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: results of an open-label, single-arm pilot study. J Eur Acad Dermatol Venereol 2008; 22: 345-352.
• 49 Puig L., Roé E., García-Navarro X., Corella F., Alomar A. Efalizumab treatment of psoriasis vulgaris: a cohort study in outpatient clinical practice. Clin Exp Dermatol 34 (04) 2009; 469-475.
• 50 Lotti T., Chimenti S., Katsambas A. et al. Efficacy and safety of efalizumab in patients with moderate-to-severe plaque psoriasis resistant to previous anti-psoriatic treatment: results of a multicentre, open-label, Phase IIIb/IV trial. Arch Drug Info 2010; 3: 9-18.
• 51 Kothary N., Diak I.L., Brinker A., Bezabeh S., Avigan M., Dal Pan G. Progressive multifocal leukoencephalopathy associated with efalizumab use in psoriasis patients. J Am Acad Dermatol 65 (03) 2011; 546-551.
• 52 Morell L., Carrascosa J.M., Ferrándiz C. et al. Grupo Español de Psoriasis Clinical characteristics and disease course in patients treated with efalizumab following suspension of marketing authorization by the European medicines agency: a multicenter observational study. Actas Dermosifiliogr 102 (05) 2011; 354-364.
• 53 Maskatia Z.K., Koo J. Rebound of psoriasis after efalizumab discontinuation, despite being on high-dose. J Drugs Dermatol 6 (09) 2007; 941-944.
• 54 Antoniou C., Dessinioti C., Vergou T. et al. Sequential treatment with biologics: switching from efalizumab to etanercept in 35 patients with high-need psoriasis. J Eur Acad Dermatol Venereol 24 (12) 2010; 1413-1420.
• 55 Talamonti M., Teoli M., Botti E., Spallone G., Chimenti S., Costanzo A. Patients with moderate to severe plaque psoriasis: one year after the European Medicines Agency recommendation of efalizumab suspension. Dermatology 222 (03) 2011; 250-255.
• 56 Baniandrés O., Pulido A., Silvente C., Suárez R., Lázaro P. Clinical outcomes in patients with psoriasis following discontinuation of efalizumab due to suspension of marketing authorization. Actas Dermosifiliogr 101 (05) 2010; 421-427.
• 57 Cafardi J.A., Cantrell W., Wang W., Elmets C.A., Elewski B.E. The safety and efficacy of high-dose alefacept compared with a loading dose of alefacept in patients with chronic plaque psoriasis. Skinmed 2008; 7: 67-72.
• 58 Brezinski E.A., Armstrong A.W. Off-label biologic regimens in psoriasis: a systematic review of efficacy and safety of dose escalation, reduction, and interrupted biologic therapy. PLoS One 7 (04) 2012; e33486.
• 59 Zaragoza V., Pérez A., Sánchez J.L., Oliver V., Martínez L., Alegre V. Long-term safety and efficacy of etanercept in the treatment of psoriasis. Actas Dermosifiliogr 101 (01) 2010; 47-53.
• 60 Puig Sanz L., Sáez E., Lozano M.J. et al. Reactions to infliximab infusions in dermatologic patients: consensus statement and treatment protocol. Working Group of the Grupo Español de Psoriasis de la Academia Española de Dermatología y Venereología. Actas Dermosifiliogr 100 (02) 2009; 103-112.
• 61 Lecluse L.L.A., Piskin G., Mekkes J.R., Bos J.D., de Rie M.A. Review and expert opinion on prevention and treatment of infliximab-related infusion reactions. Br J Dermatol 2008; 159: 527-536.
• 62 Wendling D., Prati C. Paradoxical effects of anti-TNFα agents in inflammatory diseases. Expert Rev Clin Immunol 10 (01) 2014; 159-169.
• 63 Goiriz R., Dauden E., Perez-Gala S., Guhl G., Garcia-Diez A. Flare and change of psoriasis morphology during the course of treatment with tumour necrosis factor blockers. Clin Exp Dermatol 2007; 32: 176-179.
• 64 Collamer A.N., Guerrero K.T., Henning J.S., Battafarano D.F. Psoriatic skin lesions induced by tumor necrosis factor antagonist therapy: a literature review and potential mechanisms of action. Arthritis Rheum 2008; 59: 996-1001.
• 65 Wollina U., Hansel G., Koch A., Schonlebe J., Kostler E., Haroske G. Tumor necrosis factor-alpha inhibitor-induced psoriasis or psoriasiform exanthemata: first 120 cases from the literature including a series of six new patients. Am J Clin Dermatol 2008; 9: 1-14.
• 66 Wendling D., Balblanc J.C., Briançon D. et al. Onset or exacerbation of cutaneous psoriasis during TNFα antagonist therapy. Joint Bone Spine 2008; 75: 315-318.
• 67 Santos-Juanes J., Coto-Segura P., Mas-Vidal A., Galache Osuna C. Ustekinumab induces rapid clearing of erythrodermic psoriasis after failure of antitumour necrosis factor therapies. Br J Dermatol 2010; 162: 1144-1146.
• 68 Collamer A.N., Battafarano D.F. Psoriatic skin lesions induced by tumor necrosis factor antagonist therapy: clinical features and possible immunopathogenesis. Semin Arthritis Rheum 2010; 40: 233-240.
• 69 Denadai R., Teixeira F.V., Steinwurz F., Romiti R., Saad-Hossne R. Induction or exacerbation of psoriatic lesions during anti-TNFα therapy for inflammatory bowel disease: a systematic literature review based on 222 cases. J Crohns Colitis 7 (07) 2013; 517-524.
• 70 Navarro R., Daudén E. Clinical management of paradoxical psoriasiform reactions during TNFα therapy. Actas Dermosifiliogr 105 (08) 2014; 752-761.
• 71 Kary S., Worm M., Audring H. et al. New onset or exacerbation of psoriatic skin lesions in patients with definite rheumatoid arthritis receiving tumour necrosis factor alpha antagonists. Ann Rheum Dis 2006; 65: 405-407.
• 72 Ko J.M., Gottlieb A.B., Kerbleski J.F. Induction and exacerbation of psoriasis with TNF-blockade therapy: a review and analysis of 127 cases. J Dermatol Treat 2009; 20: 100-108.
• 73 Havla J.B., Pellkofer H.L., Meinl I., Gerdes L.A., Hohlfeld R., Kümpfel T. Rebound of disease activity after withdrawal of fingolimod (FTY720) treatment. Arch Neurol 69 (02) 2012; 262-264.
• 74 Piscolla E., Hakiki B., Pastò L., Razzolini L., Portaccio E., Amato M.P. Rebound after fingolimod suspension in a pediatric-onset multiple sclerosis patient. J Neurol 260 (06) 2013; 1675-1677.
• 75 Sempere A.P., Berenguer-Ruiz L., Feliu-Rey E. Rebound of disease activity during pregnancy after withdrawal of fingolimod. Eur J Neurol 20 (08) 2013; e109-e110.
• 76 Alroughani R., Almulla A., Lamdhade S., Thussu A. Multiple sclerosis reactivation postfingolimod cessation: is it IRIS?. BMJ Case Rep 2014; 2014: 206314.
• 77 Killestein J., Vennegoor A., van Golde A.E., Bourez R.L., Wijlens M.L., Wattjes M.P. PML-IRIS during fingolimod diagnosed after natalizumab discontinuation. Case Rep Neurol Med 2014; 2014: 307872.
• 78 Cohen M., Maillart E., Tourbah A. et al. Switching from natalizumab to fingolimod in multiple sclerosis: a French prospective study. JAMA Neurol 71 (04) 2014; 436-441.
• 79 Gueguen A., Roux P., Deschamps R. et al. Abnormal inflammatory activity returns after natalizumab cessation in multiple sclerosis. J Neurol Neurosurg Psychiatry 85 (09) 2014; 1038-1040.
• 80 Fox R.J., Cree B.A., De Sèze J. et al. MS disease activity in RESTORE: a randomized 24-week natalizumab treatment interruption study. Neurology 82 (17) 2014; 1491-1498.
• 81 Schön M.P. Efalizumab in the treatment of psoriasis: mode of action, clinical indications, efficacy, and safety. Clin Dermatol 26 (05) 2008; 509-514.
• 82 Tan I.L., McArthur J.C., Clifford D.B., Major E.O., Nath A. Immune reconstitution inflammatory syndrome in natalizumab-associated PML. Neurology 77 (11) 2011; 1061-1067.
• 83 Tridente G. Systemic adverse events with biomedicines. Int Trends Immun 2 (03) 2014; 93-110.
• 84 Teixeira M.Z. ‘Paradoxical strategy for treating chronic diseases’: a therapeutic model used in homeopathy for more than two centuries. Homeopathy 2005; 94: 265-266.
• 85 Bond R.A. Is paradoxical pharmacology a strategy worth pursuing?. Trends Pharmacol Sci 2001; 22: 273-276.
• 86 Yun A.J., Lee P.Y., Bazar K.A. Paradoxical strategy for treating chronic diseases where the therapeutic effect is derived from compensatory response rather than drug effect. Med Hypotheses 2005; 64: 1050-1059.
• 87 Page C. Paradoxical pharmacology: turning our pharmacological models upside down. Trends Pharmacol Sci 2011; 32: 197-200.
• 88 Davies C.J., Davies D.M. Paradoxical reactions to commonly used drugs. Adverse Drug React Bull 2011; 211: 807-810.
• 89 Bond R.A., Giles H. For the love of paradox: from neurobiology to pharmacology. Behav Pharmacol 2011; 22: 385-389.
• 90 Smith S.W., Hauben M., Aronson J.K. Paradoxical and bidirectional drug effects. Drug Saf 2012; 35: 173-189.
• 91 Bristow M.R. Beta-adrenergic receptor blockade in chronic heart failure. Circulation 2000; 101: 558-569.
• 92 Ho C.Y. Hypertrophic cardiomyopathy in 2012. Circulation 2012; 125: 1432-1438.
• 93 Dickey B.F., Walker J.K., Hanania N.A., Bond R.A. beta-Adrenoceptor inverse agonists in asthma. Curr Opin Pharmacol 2010; 10: 254-259.
• 94 Loffing J. Paradoxical antidiuretic effect of thiazides in diabetes insipidus: another piece in the puzzle. Am Soc Nephrol 2004; 15: 2948-2950.
• 95 Cui X., Kobayashi Y., Akashi M., Okayasu R. Metabolism and the paradoxical effects of arsenic: carcinogenesis and anticancer. Curr Med Chem 2008; 15: 2293-2304.
• 96 Platanias L.C. Biological responses to arsenic compounds. J Biol Chem 2009; 284: 18583-18587.
• 97 Oberbaum M., Frass M., Gropp C. Unequal brothers: are homeopathy and hormesis linked?. Homeopathy 104 (02) 2015; 97-100.
• 98 Oberbaum M., Frass M., Gropp C. Update on hormesis and its relation to homeopathy. Homeopathy 104 (04) 2015; 227-233.
• 99 Teixeira M.Z. Homeopathic use of modern medicines: utilisation of the curative rebound effect. Med Hypotheses 2003; 60: 276-283.
• 100 Teixeira M.Z. New homeopathic medicines: use of modern drugs according to the principle of similitude. Homeopathy 2011; 100: 244-252.
• 101 Teixeira M.Z. Homeopathic use of modern drugs: therapeutic application of the organism paradoxical reaction or rebound effect. Int J High Dilution Res 10 (37) 2011; 338-352.
• 102 Teixeira M.Z. ‘New Homeopathic Medicines’ database: a project to employ conventional drugs according to the homeopathic method of treatment. Eur J Integr Med 2013; 5: 270-278.
• 103 Teixeira M.Z. Therapeutic use of the rebound effect of modern drugs: ‘new homeopathic medicines’. Rev Assoc Med Bras 2017; 63 (02) [in press].
• 104 The United States Pharmacopeial Convention. The United States pharmacopeia dispensing information. 24^a edn Easton: Mack Printing Co; 2004.
• 105 Teixeira M.Z. New homeopathic medicines: use of modern drugs according to the principle of similitude. 3 Vol São Paulo: Marcus Zulian Teixeira; 2010. Available at: http://www.newhomeopathicmedicines.com.
• 106 Teixeira MZ, Podgaec S, Baracat EC. Homeopathic treatment of chronic pelvic pain in women with endometriosis. ClinicalTrials.gov Identifier:. NCT02427386.
• 107 Teixeira M.Z., Podgaec S., Baracat E.C. Protocol of randomized controlled trial of potentized estrogen in homeopathic treatment of chronic pelvic pain associated with endometriosis. Homeopathy 2016; 105: 240-249.
• 108 Kim G.K., Del Rosso J.Q. Drug-provoked psoriasis: is it drug induced or drug aggravated? Understanding pathophysiology and clinical relevance. J Clin Aesthet Dermatol 3 (01) 2010; 32-38.