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Sustained Efficacy and Safety of Adalimumab in Psoriasis Treatment

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Sustained Efficacy and Safety of Adalimumab in Psoriasis Treatment of these 2 diseases. Based on our limited findings in this Adalimumab, the third TNF-␣ antagonist, is currently study, we do not recommend a screening eye examina- in phase III trials for psoriasis treatment. As a fully human tion for uveitis in patients with GA. IgG1 monoclonal antibody, it is expected to have less im- munogenicity and secondary antibody-mediated loss of ef- Nicole V. Brey, MD ficacy.1,2 Despite clinical reports of antiadalimumab anti- Todd J. Purkiss, MD, PhD bodies, impact on long-term clinical response is unclear.4 Ashok Sehgal, MD One recent study demonstrated adalimumab to be ef- Henry J. Kaplan, MD ficacious for psoriasis treatment of patients with no pre- Jeffrey P. Callen, MD vious exposure to TNF antagonists.5 Since it is uncer- tain whether long-term response to adalimumab (Ն12 Correspondence: Dr Callen, 310 E Broadway, Ste 2A, months) can be sustained in patients for whom other anti- Louisville, KY 40202 ([email protected]). TNF therapy has failed to treat moderate to severe plaque Author Contributions: Drs Kaplan and Callen had full ac- psoriasis, we address this question retrospectively in 49 cess to all the data in the study and take responsibility for patients with and without prior use of TNF-␣ blockade. the integrity of the data and the accuracy of the data analy- sis. Study concept and design: Brey, Purkiss, and Callen. Methods. This retrospective medical chart review in- Acquisition of data: Brey, Purkiss, and Sehgal. Analysis and cludes 49 patients seen at the Baylor College of Medicine interpretation of data: Purkiss and Kaplan. Drafting of the dermatology clinic. All patients had moderate to severe pso- manuscript: Brey and Purkiss. Critical revision of the manu- riasis based on the physician’s global assessment (PGA) and scriptforimportantintellectualcontent:Purkiss,Sehgal,Kaplan, had started treatment with adalimumab injections at least and Callen. Statistical analysis: Purkiss. Obtained funding: 12 months previously. All were screened for tuberculosis. Kaplan.Administrative,technical,andmaterialsupport:Purkiss Patients who had undergone prior therapy with biological and Kaplan. Study supervision: Kaplan and Callen. agents were switched to adalimumab therapy only after they Financial Disclosure: None reported. had experienced lack or loss of efficacy with their prior treat- Funding/Support: This study was supported by fund- ment. Patients switched from infliximab therapy had a wash- ing from Research to Prevent Blindness, New York, New out period of at least 2 months, and those switched from York (Drs Purkiss, Sehgal, and Kaplan), and the Com- etanercept or efalizumab had a washout period of at least monwealth of Kentucky Research Challenge Trust Fund, 2 weeks. Frankfort (Dr Kaplan). Patientsstartedtreatmentwithadalimumab,40mgweekly, Disclaimer: Dr Callen is the associate editor of Archives for 12 weeks. All were reassessed at 3 months. Patients whose of Dermatology; he was not involved in the editorial evalu- disease was determined to be “clear” or “almost clear” by ation or editorial decision to accept this work for pub- PGA had their doses decreased to once every 2 weeks, while lication. theremaindercontinuedweeklydosingforanother3months. 1. Oz O, Tursen U, Yildirim O, Kaya TI, Ikizoglu G. Uveitis associated with granu- Patients were then reassessed at 3- to 6-month intervals, dur- loma annulare. Eur J Ophthalmol. 2003;13(1):93-95. ing which the dermatologist decreased the dosing frequency 2. Rahimi M, Moinfar N. Granuloma annulare and anterior uveitis. Iranian J Med Sci. 2005;30(3):144-146. to once every 2 weeks or continued the weekly schedule, 3. van Kooij B, van Dijk MC, de Boer J, Sigurdsson V, Rothova A. Is granuloma depending on individual response. annulare related to intermediate uveitis with retinal vasculitis? Br J Ophthalmol. 2003;87(6):763-766. The clinical end point was defined as worsening PGA 4. Jabs DA, Nussenblatt RB, Rosenbaum JT; The Standardization of Uveitis No- despite continuous adalimumab treatment or the occur- menclature (SUN) Working Group. Standardization of uveitis nomenclature rence of adverse events necessitating discontinuation of for reporting clinical data: results of the first international workshop. Am J Ophthalmol. 2005;140(3):509-516. adalimumab treatment. Treatment failure was differen- 5. Gritz DC, Wong IG. Incidence and prevalence of uveitis in Northern Cali- tiated into primary lack of efficacy (no clinical response fornia: the Northern California epidemiology of uveitis study. Ophthalmology. seen), secondary loss of efficacy (PGA degrades to lower 2004;111(3):491-500. 6. Durrani OM, Meads CA, Murray PI. Uveitis: a potentially blinding disease. than clear or almost clear after an initial response), and Ophthalmologica. 2004;218(4):223-236. limited efficacy (clinical response seen, but patient never achieves clear or almost clear status). Results. Thirty-nine patients had prior exposure to bio- Sustained Efficacy and Safety logical agents (80%). Thirty-seven had prior anti– of Adalimumab in Psoriasis Treatment: TNF-␣ therapy (76%) (Figure 1). No complications were A Retrospective Study of 49 Patients observed during transitions from prior biological agents. With and Without a History of TNF-␣ Forty-three patients achieved clear to almost clear sta- Antagonist Treatment tus at 3 months (88%), 3 at 6 months, and 1 at 9 months, while 2 continued to received weekly dosing because they f the 3 available tumor necrosis factor ␣ (TNF-␣) did not achieve clear to almost clear status. Two pa- antagonists, infliximab and etanercept are ap- tients, whose dose had been decreased to 1 every 2 weeks proved for treatment of moderate to severe, at 3 months, resumed weekly dosing at 9 months. Sus- O 1,2 chronic, plaque-type psoriasis. Although no standard- tained efficacy at 12 months was observed in 38 patients ized comparison trial exists, infliximab appears to be the (78%). Of the 39 previously treated with biological agents, most rapidly effective, but this initial efficacy is often even- 31 experienced sustained efficacy with adalimumab (79%). tually lost with the development of human antichimeric Of the 37 who had been treated with TNF-␣ antago- antibodies in 15% to 69% of patients.1-3 nists, 29 had a sustained response (78%). Figure 2 sum- (REPRINTED) ARCH DERMATOL/ VOL 144 (NO. 6), JUNE 2008 WWW.ARCHDERMATOL.COM 804 ©2008 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/27/2021 Table. Incidence of Adverse Events in 49 Patients Taking Adalimumaba Patient Treatment Month Infliximab No. Type Event of Occurrence 1 Serious Unexplained fevers 14 20 2 Serious Cellulitis 15 3 Serious Cellulitis 4 4 Serious Back pain 2 2 6 5 Serious Pyelonephritis 6 6 Serious Squamous cell carcinoma 7, 9, and 10 1 7 Minor Influenza 8 2 1 7 a Malignant neoplasms and infections requiring treatment with antibiotics or hospitalization were considered serious adverse events. Patient 4 had back pain that was later found to be due to metastatic adenocarcinoma from an unknown primary tumor; patient 6 had multiple squamous cell carcinomas. Efalizumab Etanercept proximately 78% of adalimumab patients treated with etanercept, infliximab, or both continued to have al- most clear to clear PGA status at 12 months. Figure 1. Distribution of patients using biological agents prior to adalimumab therapy. Safety. In the multicenter trial conducted by Gordon et al,5 9% of patients discontinued therapy owing to an adverse event (AE). The numbers of patients in the pla- cebo and treatment groups who experienced any AE dur- 49 Patients ing the first 12 weeks were comparable, but no serious AEs occurred in the placebo group. The investigators ques- tioned whether the reported AEs were directly attribut- able to treatment.5 40 Treated for ≥12 mo 9 Discontinued treatment The incidence of AEs in our study was 14%. Five pa- in <12 mo tients developed serious AEs (2 cellulitis and 1 each un- explained fevers, back pain, and pyelonephritis) that re- sulted in treatment termination (10%) (Table). One 38 Sustained 2 Limited 1 Pyelonephritis patient developed a serious AE (squamous cell carci- efficacy efficacy 1 Cellulitis 1 Back pain noma) but opted to continue treatment. 3 Primary lack of efficacy 1 Insurance difficulties Conclusion. Results from this study support the idea that 2 Secondary loss of efficacy ␣ at 9 mo patients with psoriasis who have received prior TNF- antagonists can expect sustained clinical response to ad- alimumab. Although our study is limited by retrospec- Figure 2. Results of adalimumab treatment for psoriasis in the 49 study tive design and small sample size, it adds to the collec- patients. tive understanding of the therapeutic role of adalimumab in the treatment of psoriasis. marizes reasons for discontinuation of adalimumab treat- ment in 9 patients prior to 12 months. Livia Van, MD Sapna V. Modi, MD Comment. Efficacy. In a multicenter study of adali- Deborah J. Yang, MD mumab in patients with psoriasis who had never been ex- Sylvia Hsu, MD posed to TNF-␣ antagonists, PGA measurements in the weekly treatment group showed a decline in the number Correspondence: Dr Hsu, Department of Dermatology- of patients with clear or almost clear status from 76% at Baylor College of Medicine, 6620 Main St, Ste 1425, Hous- week 12 to 52% at week 60.5 The PGA of clear or almost ton, TX 77030 ([email protected]). clear was comparable at 12 (49%) and 60 (44%) weeks in Author Contributions: Dr Hsu had full access to all the the group receiving 1 dose every 2 weeks. Fourteen pa- data in the study and takes responsibility for the integ- tients (11%) withdrew from the study between weeks 24 rity of the data and the accuracy of the data analysis. Study and 60 secondary to lack of efficacy.5 Our patients’ dosing concept and disign: Van and Hsu. Acquisition of data: Van regimen was based on this study’s dosage arms. and Modi. Analysis and interpretation of data: Ban, Modi, Our study contributes further evidence that most pa- Yang, and Hsu.
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