1 What adverse reactions to immunomodulators and biologics: 1) mandate discontinuation of therapy and 2) when can medications be continued? Miguel Regueiro, M.D. Professor of Medicine Associate Chief, Education Clinical Head and Co-Director, IBD Ctr University of Pittsburgh Medical Ctr
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Miguel Regueiro, M.D. Professor of Medicine Associate Chief, Education
What adverse reactions to immunomodulators and biologics: 1) mandate discontinuation of therapy and 2) when can medications be continued?. Miguel Regueiro, M.D. Professor of Medicine Associate Chief, Education Clinical Head and Co-Director, IBD Ctr University of Pittsburgh Medical Ctr. - PowerPoint PPT Presentation
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What adverse reactions to immunomodulators and biologics:
1) mandate discontinuation of therapy and
2) when can medications be continued?
Miguel Regueiro, M.D.
Professor of Medicine
Associate Chief, Education
Clinical Head and Co-Director, IBD Ctr
University of Pittsburgh Medical Ctr
Very little to no evidenced based data on this subject, so…
I called some friends for help.
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Corey Siegel – after 1 minute of laughter, “I was asked to give this talk and turned
it down…good luck!”
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David Rubin – “What are you kidding me?!?!”
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Asher Kornbluth – “I’m sorry, I can’t
hear you.”
Ed Loftus – Clearly has gone over his own cliff…….
Jean Fred Colombel – yelled something in French about the color blue being
sacred, the rest I couldn’t understand.
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So, with no help from my “friends”
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I will give you my opinion on what to do with IMMs/antiTNFs when an AE occurs.
We need to individualize this decision based on severity of IBD and AE.
I look forward to further discussion and opinion in the panel session.
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What are the main side-effects of 6MP/Azathioprine?
Siegel CA, et al. APT 2005 (weighted average); Siegel CA, et al. CGH 2009; Beaugerie L, et al. Lancet 2009.
EventFrequency Estimate
Stop therapy due to AE 11%
Allergic reactions 2%
Nausea 2%
Hepatitis 2%
Pancreatitis 3%
Serious infections 5%
non-Hodgkin’s lymphoma 0.04%-0.09% (4-9/10,000)
Adverse Events Associated with anti-TNF Treatment
Siegel CA.. The inflammatory bowel disease yearbook, volume 6. 2009; Infliximab package insert; Vermeire, Gastro 2003; Cush, Ann Rheum Dis 2005; Lenercept study group, Neurology 1999; ATTACH trial 2003
When you see this –think antiTNF mediated Psoriasis
• Several phenotypes:• Palmoplantar pustular psoriasis: form most commonly associated
with anti-TNF therapy (even in patients treated for plaque psoriasis)
JF Rahier.CGH 2010; Courtesy of Franck Delesalle
….or this……antiTNF Psoriasis
•Several phenotypes:• Inverse psoriasis (type of psoriasis in plaques)
In Psoriasis – Manson publishing; Courtesy of Franck Delesalle
Skin: Stop or Continue? What I do-Consult with Dermatology and then.….
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NMSC – Basal Cell Squamous Cell
Melanoma PSORIASIAS-like(Immune mediated)
Thiopurine
antiTNF
Skin: Stop or Continue? What I do-Consult with Dermatology and then.….
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NMSC – Basal Cell Squamous Cell
Melanoma PSORIASIAS-like(Immune mediated)
Thiopurine Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Only if significant recurrence or potential for disfiguring sequelae
antiTNF
Skin: Stop or Continue? What I do-Consult with Dermatology and then.….
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NMSC – Basal Cell Squamous Cell
Melanoma PSORIASIAS-like(Immune mediated)
Thiopurine Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Only if significant recurrence or potential for disfiguring sequelae
antiTNF Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Rarely necessary
Skin: Stop or Continue? What I do-Consult with Dermatology and then.….
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NMSC – Basal Cell Squamous Cell
Melanoma PSORIASIAS-like(Immune mediated)
Thiopurine Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Only if significant recurrence or potential for disfiguring sequelae
Continue/start:-eradicated-melanoma free for > 1 yr-no mets
Stop: New Onset?
antiTNF Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Rarely necessary
Skin: Stop or Continue? What I do-Consult with Dermatology and then.….
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NMSC – Basal Cell Squamous Cell
Melanoma PSORIASIAS-like(Immune mediated)
Thiopurine Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Only if significant recurrence or potential for disfiguring sequelae
Continue/start:-eradicated-melanoma free for > 1 yr-no mets
Stop: New Onset?
antiTNF Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Rarely necessary
Continue/start:-eradicated-melanoma free for > 1 yr-no mets
Stop: New Onset
Skin: Stop or Continue? What I do-Consult with Dermatology and then.….
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NMSC – Basal Cell Squamous Cell
Melanoma PSORIASIAS-like(Immune mediated)
Thiopurine Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Only if significant recurrence or potential for disfiguring sequelae
Continue/start:-eradicated-melanoma free for > 1 yr-no mets
Stop: New Onset?
Continue or start:
-any psoriasis, past or present
- MTX may be useful in rxing antiTNF-mediated skin ds
antiTNF Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Rarely necessary
Continue/start:-eradicated-melanoma free for > 1 yr-no mets
Stop: New Onset
Skin: Stop or Continue? What I do-Consult with Dermatology and then.….
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NMSC – Basal Cell Squamous Cell
Melanoma PSORIASIAS-like(Immune mediated)
Thiopurine Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Only if significant recurrence or potential for disfiguring sequelae
Continue/start:-eradicated-melanoma free for > 1 yr-no mets
Stop: New Onset?
Continue or start:
-any psoriasis, past or present
- MTX may be useful in rxing antiTNF-mediated skin ds
antiTNF Continue or start:Active or Past, as long as Dermatology monitoring
Stop:Rarely necessary
Continue/start:-eradicated-melanoma free for > 1 yr-no mets
Stop: New Onset
Continue:Mild, <5% skin, responds to topical tx or MTX
Stop:>5%, nonresponsive to psoriasis tx
Summary: Stop or Continue Rx?• IMMs and biologics are associated with rare, but potentially
serious AEs
• Most AEs do not mandate IMM/antiTNF cessation – individualize the decision
• I would stop/hold IMM/antiTNF for:– Active opportunistic infections (rare)– Lymphoma/Cancer (very rare)– Recurrent skin cancers– Non-responsive psoriasis to antiTNF– Allergic/idiosyncratic drug rxns
• Once AE resolves, usually restart meds
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UPMC IBD Center: Physicians and Staff
When you go out tonight, beware of:When you go out tonight, beware of: