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Certolizumab Pegol Treatment in Three Patients with Takayasu Arteritis

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Certolizumab Pegol Treatment in Three Patients with Takayasu Arteritis Arch Rheumatol 2019;34(3):357-362 doi: 10.5606/ArchRheumatol.2019.7177 CASE REPORT Certolizumab Pegol Treatment in Three Patients With Takayasu Arteritis Nuh ATAŞ, Özkan VARAN, Hakan BABAOĞLU, Hasan SATIŞ, Reyhan BİLİCİ SALMAN, Abdurrahman TUFAN Department of Internal Medicine, Division of Rheumatology, Gazi University Faculty of Medicine, Ankara, Turkey ABSTRACT Although glucocorticoids are the mainstay of treatment in Takayasu arteritis (TA), anti-tumor necrosis factor agents are other treatment options in refractory disease. The onset of TA is generally observed in females of reproductive age. Certolizumab pegol (CZP) lacks a fragment crystallizable region and this gives advantage of minimal transfer through the placenta, which makes CZP a safer option in pregnancy. Although there are case reports and trials about use of infliximab, etanercept, and adalimumab in TA, there are scarce data about use of CZP. In this article, we present three TA cases treated with CZP. While two patients benefited from CZP, one patient was refractory to CZP. Keywords: Anti-tumor necrosis factor, certolizumab pegol, pregnancy, Takayasu arteritis. Takayasu arteritis (TA) is a rare granulomatous inflammatory phase, vascular pain (particularly large vessel vasculitis which primarily affects carotidynia) tends to occur. The third burned- aorta and its major branches. TA can result out phase is characterized with arterial bruits, in stenosis, occlusion, aneurysm formation, decreased or absence of pulses and/or differences and dilatation of effected vessels.1 Females are in arterial blood pressure between upper predominantly affected with an age of onset of extremities, claudication in the legs and ischemic ≤40 years.2 Although its distribution is worldwide, symptoms.6 An overlap may be observed between it generally affects Asian populations. TA is these phases. There is no gold standard laboratory relatively uncommon in northern European and test and imaging method for diagnosis of TA. The American populations.3 Although the etiology American College of Rheumatology (ACR) criteria of TA is unknown, cell-mediated autoimmunity are the most widely used vasculitis classification and genetic factors have an important role in the criteria.7 pathogenesis of TA.4 The main target of treatment in TA is to Clinical manifestations are determined by the suppress the inflammatory process. Management affected vessels and degree of inflammation.5 of cardiovascular risk factors such as dyslipidemia, TA generally progresses through three different smoking, and hypertension is also important. phases. In the first prevasculitic phase, patients Corticosteroids (CS) are the mainstay of therapy. complain of nonspecific constitutional symptoms Methotrexate (MTX), azathioprine (AZA), such as fever, fatigue, and malaise. In the second cyclosporine, tacrolimus, mycophenolate mofetil, Received: September 14, 2018 Accepted: January 19, 2019 Published online: March 28, 2019 Correspondence: Nuh Ataş, MD. Gazi Üniversitesi Tıp Fakültesi İç Hastalıkları Anabilim Dalı, Romatoloji Bilim Dalı, 06500 Beşevler, Ankara, Turkey. Tel: +90 312 - 202 58 28 e-mail: [email protected] Citation: Ataş N, Varan Ö, Babaoğlu H, Satış H, Bilici Salman R, Tufan A. Certolizumab pegol treatment in three patients with Takayasu arteritis. Arch Rheumatol 2019;34(3):357-362. ©2019 Turkish League Against Rheumatism. All rights reserved. 358 Arch Rheumatol and leflunomide (LEF) are second-line conventional loading dose at weeks 0, 2, 4 and 200 mg in immunosuppressive agents. Conventional agents every two weeks thereafter. A written informed are used alone or in combination to taper CS dose. consent was obtained from all patients. Tocilizumab, rituximab, and anti-tumor necrosis A literature review with no date limit was factor (anti-TNF) agents are treatment options performed for the manuscripts about CZP use in in refractory cases.6,8,9 Angioplasty and stenting TA. The search was performed in two electronic may be used to treat stenotic lesions that cause databases (MEDLINE/PubMed and Scopus) using ischemic symptoms.10 Although anti-TNF agents the following search terms: ‘‘Takayasu arteritis’’, are used in treatment of TA, interestingly, there ‘‘large vessel vasculitis’’ and ‘‘certolizumab.’’ We are case reports of TA developing after initiation included all manuscripts (case reports, search of these agents in the literature.11-13 In these articles, case control, cohort or cross-sectional case reports, two patients with spondyloarthritis, one patient with rheumatoid arthritis, and one studies) related with TA and CZP. Exclusion patient with Crohn’s disease developed TA after criteria were manuscripts which were not treatment with anti-TNF agents. This paradoxical accessible in full-text or publication in languages effect may be due to the presence of different other than English. After analysis, we found one 17 pathophysiologic pathways in a subgroup of brief report about CZP use in TA. We also patients with TA. realized an abstract related with CZP use in TA in 2018 ACR/Association of Rheumatology Health The currently used anti-TNF-alpha (a) Professionals (ARHP) Annual Meeting.18 agents in treatment of autoimmune disorders are etanercept (ETA) (TNF-a-receptor fusion protein), infliximab (IFX), adalimumab (ADA), CASE REPORT golimumab (anti-TNF-a monoclonal antibodies), and certolizumab pegol (CZP). CZP is a PEGylated Case 1- A 42-year-old female patient was antigen-binding fragment (Fab) of monoclonal operated with bypass graft for left subclavian antibody to TNF-a. CZP binds and neutralizes artery stenosis causing arm claudication soluble and transmembrane TNF-a. Unlike in 2009 and subsequently diagnosed of TA other TNF-a inhibitors, CZP lacks a fragment with classical angiography consistent with crystallizable (Fc) region. This decreases potential type 2a TA involvement. MTX and 1 mg/kg Fc-mediated effects such as complement and methylprednisolone (MP) were prescribed at the antibody dependent cell-mediated cytotoxicity.14 beginning of treatment. In follow-up, because In addition, lack of a Fc region gives advantage of inefficacy, MTX was switched to AZA which of minimal transfer through the placenta, which caused pancreatitis. Then, AZA was changed 15 makes CZP a safer option in pregnancy. There to LEF ensuing clinical and laboratory remission are no sufficient data about CZP use in TA in for three years. In follow-up, patient developed the literature. Therefore, in this study, we aimed back pain and control magnetic resonance (MR) to share our experience about CZP use in three angiography revealed progression in stenosis of patients with a diagnosis of TA. ascending aorta when compared to previous MR Diagnosis of patients were in accordance with angiography image. After pulse steroid (1 g/day, ACR classification criteria and we used Kerr’s three consecutive days), IFX treatment was begun. criteria (National Institutes of Health) for the With IFX treatment, back pain and other evaluation of disease activity in our patients.16 constitutional symptoms improved. The levels According to Kerr’s criteria, new onset or worsening of ESR and C-reactive protein (CRP) decreased of at least two of the following four criteria shows to normal range. There was no progression in active disease: (i) systemic features such as malaise, control MR angiography which was performed weight loss, fever, and arthralgia with no identified at first year of IFX treatment. On second year of cause, (ii) elevated erythrocyte sedimentation IFX treatment, patient developed constitutional rate (ESR), (iii) findings of vascular ischemia or symptoms and elevation of ESR and CRP was inflammation, like claudication, diminished or observed. For this reason, IFX was switched to absent pulse, (iv) typical angiographic features. ETA due to loss of efficacy. Six months later, The administration dosage of CZP was 400 mg she admitted to our clinic with abdominal pain, Certolizumab Pegol in Takayasu Arteritis 359 weight loss, and bloody diarrhea. Colonoscopy 26 mg/L, respectively. Patient was prescribed revealed focal ulcerations adjacent to areas of CZP along with MTX. On follow-up visit, after normal appearing mucosa and polypoid mucosal 15 weeks of CZP treatment, she still complained changes that give a cobblestone appearance and of carotidynia and marked malaise. Her ESR and diagnosed as Crohn’s disease. After diagnosis of CRP levels were 42 mm/hour and 22 mg/L, Crohn’s disease, ETA was switched to CZP and respectively, and CZP was switched to IFX LEF was continued. She was treated with CZP for which was also ineffective with 16 weeks of use. 26 months and she is still in clinical, laboratory, Finally, she achieved remission with tocilizumab and angiographic remission for TA. Crohn’s treatment. disease is also in remission. Case 3- A 33-year-old female patient was Case 2- A 46-year-old female patient was diagnosed of TA in 2013 with complaints diagnosed of TA in 2010 with complaints of of malaise, anorexia, systolic blood pressure headache, carotidynia, malaise, lassitude, difference, high ESR (120 mm/hour) and CRP and syncope. There were bruits over carotid (79 mg/L), and type V angiographic involvement. arteries and left subclavian artery, absence of MTX and 1 mg/kg MP were prescribed at left arm pulses, and systolic blood pressure the beginning of treatment. Because of gastric difference between two arms. ESR and CRP intolerance, MTX was changed to LEF. We levels were 65 (normal: 0-20) mm/hour and tapered MP dose gradually. With 15 mg/day 30 (normal: 0-5) mg/L, respectively, at initial dose of MP, we observed elevation of ESR presentation. Angiographic involvement was (80/hour) and CRP (58 mg/L) with complaints consistent with type 2b TA. Methylprednisolone of weakness, malaise, and fever. On control 1 mg/kg day and MTX 15 mg/week were MR angiography, a new finding, narrowing of prescribed initially. She was doing well with left renal artery that involved 8.5 cm segment this treatment for five years but presented with with contrast enhancement and edema of complaints of carotidynia, back pain, and malaise vascular wall, was observed. Patient had plans while receiving MTX 15 mg and MP 10 mg/day.
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