Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
NCT ID: NCT02687620
Last Updated: 2021-02-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
180 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-09-30
Study Completion Date
2021-04-30
Brief Summary
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The purpose of this prospective cohort study is to evaluate the influence of serum drug levels and development of anti-drug antibodies on clinical response to anti-TNF agents in ankylosing spondylitis(AS) treatment. Secondary aims are to assess the demographic, clinical and laboratory variables associated with the development of anti-TNF drug antibodies at baseline or disease course and to reveal the impact of anti-drug antibodies on long-term efficacy or safety in particular drug survival in AS patients treated in daily clinical practice.
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Detailed Description
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Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that predominantly affects sacroiliac joints and spine. It is the prototype of spondyloarthritides (SpA) and one of the most common rheumatic diseases. Sacroiliitis is the earliest manifestation of disease and accompanying with spinal involvement cause inflammatory back pain (IBP). IBP usually starts insidiously in the early adulthood and typically it is felt deep in the buttock and/or lower lumbar regions. It improves with activity and returns with the rest and is usually accompanied by morning stiffness lasting at least 30 minutes. Involvement of the spine in patients with AS is usually not limited to the sacroiliac joints and lumbar region and usually it extends up to the thoracic and cervical segment. Currently the only sign that is diagnostic for AS is radiographic sacroiliitis. However radiography detects structural changes and take up to ten years to appear unequivocally.
In some patients bone tenderness due to enthesitis may be the primary complaint. Arthritis in the hips and shoulders occur in some patients and is associated with worse prognosis. Typical arthritis pattern in AS patients is asymmetric and usually involves the lower extremity joints. There are several extra-articular features of AS and the most common is acute anterior uveitis.
Until recently treatment options for AS were limited and based on non-steroidal anti-inflammatory drugs (NSAIDs), traditional disease modifying anti-rheumatic drugs (DMARDs) for the rheumatoid arthritis and physical therapy. The last decade witnessed a major advance in AS therapy with the use of anti-tumor necrosis factor (anti-TNF) agents. Anti-TNF agents have a substantial effect not only the axial disease but also in peripheral arthritis, enthesitis and extra-articular features (like psoriasis and inflammatory bowel disease). Currently there are four anti-TNF agents approved for AS: (1) infliximab which is a monoclonal chimeric antibody and given at a dose of 5 mg/kg every 6-8 weeks; (2) etanercept which is human TNF receptor fusion protein and administered subcutaneously at a dose of 50 mg/once a week; (3) adalimumab which is a humanized monoclonal antibody and administered as subcutaneous injection at a dose of 40 mg fortnightly; and (4) golimumab which is a fully human monoclonal antibody and administered subcutaneously at a dose of 50 mg once a month.
Since there is no head-to-head studies comparing the anti-TNF agents in the treatment of AS patients there is no ranking for the prescription of anti-TNF agents. Mixed treatment comparisons (that is statistical model allowing the simultaneous multiple meta-analysis of different pair-wise comparisons) between infliximab, adalimumab and etanercept did not show a statistically significant difference. Indeed similar improvements in Bath ankylosing spondylitis activity index (BASDAI 50) scores and ASAS partial remission (between 45.2% to 51.0% BASDAI 50 and 22.1% to 22.4% for partial remission) have been reported in randomized controlled clinical trials.
Although many AS patients respond very well to anti-TNF therapy, a considerable amount of them do not and additionally a significant proportion of patients have to stop their treatment. In clinical practice the reported 1-year and 2-year drug survival rates for anti-TNF agents are 70-85% and 60-75%, respectively.Moreover in a substantial proportion of patients either increase in the administered dosage or dosing frequency have become necessary. Therefore factors, which can predict the response or related with the primary or secondary non-response for anti-TNF treatment have a growing attention among treating specialists. In a study providing an overview of clinical trials and observational studies showed that increased acute phase reactants, higher disease activity, functional status, younger age, and HLA-B27 positivity were independent baseline predictors of response to anti-TNF treatment and increased acute phase reactants, presence of peripheral arthritis, and male sex were the predictors of long-term drug survival.
Immunogenicity refers to development of antibodies by the adaptive immune system in response to foreign substances. The development of anti-drug antibodies were extensively studied in rheumatoid arthritis and it was shown that anti-drug antibodies has a varying impact on the clinical efficacy depending on whether these antibodies are neutralizing or non-neutralizing. Recent review demonstrated that neutralizing antibodies are associated with a reduced chance of achieving a minimal disease activity or clinical remission, decreased drug survival, increased dose escalation and adverse drug reactions in RA patients. However data regarding the immunogenicity in patients treated with AS is scarce and somewhat controversial. In a small study including 38 AS patients treated with infliximab de Vries et al showed that anti-infliximab antibodies was found significantly more often (59% vs 5%) and mean serum through infliximab levels were significantly lower in ASAS20 non-responders. In the above-mentioned study infusion reactions were also seemed to be associated with the development of anti-drug antibodies. In another study de Vries et al (26) were found no antibodies to etanercept and similar serum etanercept levels in responder and non-responder AS patients (n=53). Same group also observed that anti-adalimumab antibodies were become detectable in 31% of AS (n=35) patients in 6 months period and this corresponded with diminished serum drug levels.
Arends et al reported that 0 to 30% of AS patients (n=60) developed anti-drug antibodies during one year of follow-up of anti-TNF treatment and patients with anti-IFN or anti-ADA antibodies had significantly lower drug serum levels.
The objective of this prospective cohort study is to evaluate the influence of serum drug levels and development of anti-drug antibodies on clinical response to anti-TNF agents. The assessment of demographic, clinical and laboratory variables associated with the development of anti-TNF drug antibodies at baseline or disease course will be also evaluated. Via this study, it might also be possible to reveal the impact of anti-drug antibodies on long-term efficacy or safety in particular drug survival in AS patients treated in daily clinical practice.
In some patients bone tenderness due to enthesitis may be the primary complaint. Arthritis in the hips and shoulders occur in some patients and is associated with worse prognosis. Typical arthritis pattern in AS patients is asymmetric and usually involves the lower extremity joints. There are several extra-articular features of AS and the most common is acute anterior uveitis.
Until recently treatment options for AS were limited and based on non-steroidal anti-inflammatory drugs (NSAIDs), traditional disease modifying anti-rheumatic drugs (DMARDs) for the rheumatoid arthritis and physical therapy. The last decade witnessed a major advance in AS therapy with the use of anti-tumor necrosis factor (anti-TNF) agents. Anti-TNF agents have a substantial effect not only the axial disease but also in peripheral arthritis, enthesitis and extra-articular features (like psoriasis and inflammatory bowel disease). Currently there are four anti-TNF agents approved for AS: (1) infliximab which is a monoclonal chimeric antibody and given at a dose of 5 mg/kg every 6-8 weeks; (2) etanercept which is human TNF receptor fusion protein and administered subcutaneously at a dose of 50 mg/once a week; (3) adalimumab which is a humanized monoclonal antibody and administered as subcutaneous injection at a dose of 40 mg fortnightly; and (4) golimumab which is a fully human monoclonal antibody and administered subcutaneously at a dose of 50 mg once a month.
Since there is no head-to-head studies comparing the anti-TNF agents in the treatment of AS patients there is no ranking for the prescription of anti-TNF agents. Mixed treatment comparisons (that is statistical model allowing the simultaneous multiple meta-analysis of different pair-wise comparisons) between infliximab, adalimumab and etanercept did not show a statistically significant difference. Indeed similar improvements in Bath ankylosing spondylitis activity index (BASDAI 50) scores and ASAS partial remission (between 45.2% to 51.0% BASDAI 50 and 22.1% to 22.4% for partial remission) have been reported in randomized controlled clinical trials.
Although many AS patients respond very well to anti-TNF therapy, a considerable amount of them do not and additionally a significant proportion of patients have to stop their treatment. In clinical practice the reported 1-year and 2-year drug survival rates for anti-TNF agents are 70-85% and 60-75%, respectively.Moreover in a substantial proportion of patients either increase in the administered dosage or dosing frequency have become necessary. Therefore factors, which can predict the response or related with the primary or secondary non-response for anti-TNF treatment have a growing attention among treating specialists. In a study providing an overview of clinical trials and observational studies showed that increased acute phase reactants, higher disease activity, functional status, younger age, and HLA-B27 positivity were independent baseline predictors of response to anti-TNF treatment and increased acute phase reactants, presence of peripheral arthritis, and male sex were the predictors of long-term drug survival.
Immunogenicity refers to development of antibodies by the adaptive immune system in response to foreign substances. The development of anti-drug antibodies were extensively studied in rheumatoid arthritis and it was shown that anti-drug antibodies has a varying impact on the clinical efficacy depending on whether these antibodies are neutralizing or non-neutralizing. Recent review demonstrated that neutralizing antibodies are associated with a reduced chance of achieving a minimal disease activity or clinical remission, decreased drug survival, increased dose escalation and adverse drug reactions in RA patients. However data regarding the immunogenicity in patients treated with AS is scarce and somewhat controversial. In a small study including 38 AS patients treated with infliximab de Vries et al showed that anti-infliximab antibodies was found significantly more often (59% vs 5%) and mean serum through infliximab levels were significantly lower in ASAS20 non-responders. In the above-mentioned study infusion reactions were also seemed to be associated with the development of anti-drug antibodies. In another study de Vries et al (26) were found no antibodies to etanercept and similar serum etanercept levels in responder and non-responder AS patients (n=53). Same group also observed that anti-adalimumab antibodies were become detectable in 31% of AS (n=35) patients in 6 months period and this corresponded with diminished serum drug levels.
Arends et al reported that 0 to 30% of AS patients (n=60) developed anti-drug antibodies during one year of follow-up of anti-TNF treatment and patients with anti-IFN or anti-ADA antibodies had significantly lower drug serum levels.
The objective of this prospective cohort study is to evaluate the influence of serum drug levels and development of anti-drug antibodies on clinical response to anti-TNF agents. The assessment of demographic, clinical and laboratory variables associated with the development of anti-TNF drug antibodies at baseline or disease course will be also evaluated. Via this study, it might also be possible to reveal the impact of anti-drug antibodies on long-term efficacy or safety in particular drug survival in AS patients treated in daily clinical practice.
Conditions
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Ankylosing Spondylitis
Axial Spondyloarthritis
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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AS patients receiving Anti-TNF treatment
Three hundred and fifty consecutive AS patients fulfilling the modified New York criteria for the classification of AS (5), and with a new anti-TNF agent prescription (either for the first time or switched) in the last two weeks period will be included. Treatment with anti-TNF agents will be in accordance with the regulations of Turkish Social Security Agency (SGK) on the initiation and continuation of anti-TNF agents in AS, as well as ASAS/EULAR recommendations for the management of AS (29, 30).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients whom are receiving their first anti-TNF treatment(not switch)
* Ankylosing spondylitis diagnosis according to modified New York Criteria
* Patients whom were older than 18 years old on anti-TNF initiation
* Ankylosing spondylitis diagnosis according to modified New York Criteria
* Patients whom were older than 18 years old on anti-TNF initiation
Exclusion Criteria
* Spondyloarthritis other than AS
* HIV positive or malignancy
* Being treated with another biological drug prior to study
* HIV positive or malignancy
* Being treated with another biological drug prior to study
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Izmir Katip Celebi University
OTHER
Sponsor Role
lead
Responsible Party
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Dr. Servet Akar
Prof
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Servet Akar, Prof
Role: PRINCIPAL_INVESTIGATOR
İzmir Katip Celebi University School of Medicine
Locations
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Cukurova University School of Medicine
Adana, , Turkey (Türkiye)
Site Status
Ankara İbn-i Sina University School of Medicine
Ankara, , Turkey (Türkiye)
Site Status
Gülhane Askeri Tıp Akademisi School of Medicine
Ankara, , Turkey (Türkiye)
Site Status
Hacettepe University School of Medicine
Ankara, , Turkey (Türkiye)
Site Status
Adnan Menderes University School of Medicine
Aydin, , Turkey (Türkiye)
Site Status
Fırat University School of Medicine
Elâzığ, , Turkey (Türkiye)
Site Status
Osman Gazi University School of Medicine
Eskişehir, , Turkey (Türkiye)
Site Status
Goztepe Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Site Status
Istanbul University Cerrahpasa School of Medicine
Istanbul, , Turkey (Türkiye)
Site Status
Istanbul University Istanbul School of Medicine
Istanbul, , Turkey (Türkiye)
Site Status
Ege University School of Medicine
Izmir, , Turkey (Türkiye)
Site Status
İzmir Katip Celebi University School of Medicine
Izmir, , Turkey (Türkiye)
Site Status
Kocaeli University School of Medicine
Kocaeli, , Turkey (Türkiye)
Site Status
Countries
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Turkey (Türkiye)
References
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Braun J, Bollow M, Remlinger G, Eggens U, Rudwaleit M, Distler A, Sieper J. Prevalence of spondylarthropathies in HLA-B27 positive and negative blood donors. Arthritis Rheum. 1998 Jan;41(1):58-67. doi: 10.1002/1529-0131(199801)41:13.0.CO;2-G.
Reference Type
BACKGROUND
Onen F, Akar S, Birlik M, Sari I, Khan MA, Gurler O, Ergor A, Manisali M, Akkoc N. Prevalence of ankylosing spondylitis and related spondyloarthritides in an urban area of Izmir, Turkey. J Rheumatol. 2008 Feb;35(2):305-9. Epub 2007 Dec 15.
Reference Type
BACKGROUND
Sieper J, Braun J, Rudwaleit M, Boonen A, Zink A. Ankylosing spondylitis: an overview. Ann Rheum Dis. 2002 Dec;61 Suppl 3(Suppl 3):iii8-18. doi: 10.1136/ard.61.suppl_3.iii8.
Reference Type
BACKGROUND
Burgos-Vargas R, Braun J. Inflammatory back pain. Rheum Dis Clin North Am. 2012 Aug;38(3):487-99. doi: 10.1016/j.rdc.2012.08.014. Epub 2012 Sep 14.
Reference Type
BACKGROUND
van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984 Apr;27(4):361-8. doi: 10.1002/art.1780270401.
Reference Type
BACKGROUND
Feldtkeller E, Khan MA, van der Heijde D, van der Linden S, Braun J. Age at disease onset and diagnosis delay in HLA-B27 negative vs. positive patients with ankylosing spondylitis. Rheumatol Int. 2003 Mar;23(2):61-6. doi: 10.1007/s00296-002-0237-4. Epub 2002 Sep 3.
Reference Type
BACKGROUND
Mau W, Zeidler H, Mau R, Majewski A, Freyschmidt J, Stangel W, Deicher H. Clinical features and prognosis of patients with possible ankylosing spondylitis. Results of a 10-year followup. J Rheumatol. 1988 Jul;15(7):1109-14.
Reference Type
BACKGROUND
Rudwaleit M, Khan MA, Sieper J. The challenge of diagnosis and classification in early ankylosing spondylitis: do we need new criteria? Arthritis Rheum. 2005 Apr;52(4):1000-8. doi: 10.1002/art.20990. No abstract available.
Reference Type
BACKGROUND
Braun J, Deodhar A, Dijkmans B, Geusens P, Sieper J, Williamson P, Xu W, Visvanathan S, Baker D, Goldstein N, van der Heijde D; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group. Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period. Arthritis Rheum. 2008 Sep 15;59(9):1270-8. doi: 10.1002/art.24001.
Reference Type
BACKGROUND
van der Heijde D, Kivitz A, Schiff MH, Sieper J, Dijkmans BA, Braun J, Dougados M, Reveille JD, Wong RL, Kupper H, Davis JC Jr; ATLAS Study Group. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2006 Jul;54(7):2136-46. doi: 10.1002/art.21913.
Reference Type
BACKGROUND
Arends S, Brouwer E, van der Veer E, Groen H, Leijsma MK, Houtman PM, Th A Jansen TL, Kallenberg CG, Spoorenberg A. Baseline predictors of response and discontinuation of tumor necrosis factor-alpha blocking therapy in ankylosing spondylitis: a prospective longitudinal observational cohort study. Arthritis Res Ther. 2011 Jun 20;13(3):R94. doi: 10.1186/ar3369.
Reference Type
BACKGROUND
Glintborg B, Ostergaard M, Krogh NS, Dreyer L, Kristensen HL, Hetland ML. Predictors of treatment response and drug continuation in 842 patients with ankylosing spondylitis treated with anti-tumour necrosis factor: results from 8 years' surveillance in the Danish nationwide DANBIO registry. Ann Rheum Dis. 2010 Nov;69(11):2002-8. doi: 10.1136/ard.2009.124446. Epub 2010 May 28.
Reference Type
BACKGROUND
Kristensen LE, Karlsson JA, Englund M, Petersson IF, Saxne T, Geborek P. Presence of peripheral arthritis and male sex predicting continuation of anti-tumor necrosis factor therapy in ankylosing spondylitis: an observational prospective cohort study from the South Swedish Arthritis Treatment Group Register. Arthritis Care Res (Hoboken). 2010 Oct;62(10):1362-9. doi: 10.1002/acr.20258.
Reference Type
BACKGROUND
Kristensen LE, Geborek P, Saxne T. Dose escalation of infliximab therapy in arthritis patients is related to diagnosis and concomitant methotrexate treatment: observational results from the South Swedish Arthritis Treatment Group register. Rheumatology (Oxford). 2009 Mar;48(3):243-5. doi: 10.1093/rheumatology/ken467. Epub 2008 Dec 23.
Reference Type
BACKGROUND
Alawadhi A, Alawneh K, Alzahrani ZA. The effect of neutralizing antibodies on the sustainable efficacy of biologic therapies: what's in it for African and Middle Eastern rheumatologists. Clin Rheumatol. 2012 Sep;31(9):1281-7. doi: 10.1007/s10067-012-2040-2. Epub 2012 Aug 9.
Reference Type
BACKGROUND
de Vries MK, Wolbink GJ, Stapel SO, de Vrieze H, van Denderen JC, Dijkmans BA, Aarden LA, van der Horst-Bruinsma IE. Decreased clinical response to infliximab in ankylosing spondylitis is correlated with anti-infliximab formation. Ann Rheum Dis. 2007 Sep;66(9):1252-4. doi: 10.1136/ard.2007.072397. Epub 2007 May 1.
Reference Type
BACKGROUND
de Vries MK, van der Horst-Bruinsma IE, Nurmohamed MT, Aarden LA, Stapel SO, Peters MJ, van Denderen JC, Dijkmans BA, Wolbink GJ. Immunogenicity does not influence treatment with etanercept in patients with ankylosing spondylitis. Ann Rheum Dis. 2009 Apr;68(4):531-5. doi: 10.1136/ard.2008.089979. Epub 2008 Mar 28.
Reference Type
BACKGROUND
de Vries MK, Brouwer E, van der Horst-Bruinsma IE, Spoorenberg A, van Denderen JC, Jamnitski A, Nurmohamed MT, Dijkmans BA, Aarden LA, Wolbink GJ. Decreased clinical response to adalimumab in ankylosing spondylitis is associated with antibody formation. Ann Rheum Dis. 2009 Nov;68(11):1787-8. doi: 10.1136/ard.2009.109702. No abstract available.
Reference Type
BACKGROUND
Arends S, Lebbink HR, Spoorenberg A, Bungener LB, Roozendaal C, van der Veer E, Houtman PM, Griep EN, Limburg PC, Kallenberg CG, Wolbink GJ, Brouwer E. The formation of autoantibodies and antibodies to TNF-alpha blocking agents in relation to clinical response in patients with ankylosing spondylitis. Clin Exp Rheumatol. 2010 Sep-Oct;28(5):661-8. Epub 2010 Oct 22.
Reference Type
BACKGROUND
Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999 Dec;47(6):555-67. doi: 10.1016/s0022-3999(99)00057-4.
Reference Type
BACKGROUND
Other Identifiers
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KCU-12032014
Identifier Type: -
Identifier Source: org_study_id
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