Methotrexate and Polymyalgia Rheumatica Therapy | AAFP.Steroid-Sparing Agents in Giant Cell Arteritis
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Combined treatment of giant cell arteritis with methotrexate and prednisone. Steroid-Sparing Agents in Giant Cell Arteritis
Combined treatment of giant cell arteritis with methotrexate and prednisone.
Giant cell arteritis is the commonest form of medium-to-large vessel vasculitis, requiring long-term corticosteroid therapy.
The short- and long-term side effects of corticosteroids are many, including weight gain, psychological effects, osteoporosis, cardiometabolic complications, and infections. Various agents used in place of or in combination with corticosteroids to reduce corticosteroid-related side effects were reviewed.
However, considerable variation in practice was identified giving unclear guidance. This review included the most recent evidence on methotrexate, mycophenolate mofetil, azathioprine, cyclophosphamide, abatacept, and tocilizumab. Also discussed are encouraging results with tocilizumab in GCA patients. Amongst the agents available for steroid-sparing effects, tocilizumab demonstrated the most robust data and is consequently recommended as the agent of choice for steroid-sparing, for remission induction, remission maintenance, and treating relapsing and refractory cases of GCA.
Giant Cell temporal Arteritis GCA is a chronic, systemic vasculitis, with a distinct tropism for large and medium-sized arteries with well-developed elastic membranes. The epidemiology of GCA suggests striking differences in disease risk among ethnic groups, with the highest incidence rates found in Scandinavian and other people of Northern European descent, irrespective of their place of residence [ 1 - 5 ].
Globally, the incidence of GCA is around 27 perin persons over 50 years of age [ 6 ]. Corticosteroids are the mainstay of therapy. Prompt diagnosis and initiation of therapy is critical to prevent complications such as partial visual loss or blindness and other vascular complications [ 7 - 11 ]. The average duration of corticosteroid therapy in GCA is years, although lifelong treatment may be required in some patients [ 812 - 15 ].
Long-term corticosteroid use months or more is potentially associated with treatment-related Adverse Events AEshowever, the incidence and severity are commonly dependent on a combination of the daily dose and regimen cumulative dose [ 15 - 18 ]. These AEs include skin, gastrointestinal, ophthalmological, skeletal, adrenal, cardiometabolic, and neuropsychiatric complications [ 131719 ]. The corticosteroid-related AEs patients and rheumatologists consider the most worrisome include weight gain, psychological effects, osteoporosis, and infections [ 20 ].
Given the substantial morbidity associated with long-term corticosteroid therapy, guidelines e. The limits applied were from onwards and articles in the English language, and adult population. Relevant natural language and controlled vocabulary terms were selected and combined. Where possible, articles were restricted to systematic reviews, RCTs or case series. In a large, representative cohort of real-world patients seen in routine clinical practice of rheumatologists across the United States of America, treatment patterns were reviewed using data from electronic medical records and other sources in an ongoing and continuous updating manner.
These patients met the definition of at least two GCA-related diagnosis codes within a 1-year period, between and The mean follow-up period was 24 months with an average of 12 Rheumatology clinic visits.
This also reflects the lack of clarity around the value of additional steroid-sparing agents to avoid [ 6 ] corticosteroids. The traditional view of GCA as a corticosteroid-responsive disease is not always accurate or predictable; a spectrum of severity and extent exists. Based on treatment response, GCA patients can be divided into four subgroups; in-remission, relapsed, refractory, and corticosteroid intolerant [ 3 ].
The last three groups exhibit the greatest unmet need for adjunctive therapy [ 22 ]. A critical review of the literature published in Clinical and Experimental Rheumatology [ 23 ] revealed five case series with large cohorts. These reported inconsistent efficacy, but reductions in relapse rate and in overall corticosteroids exposure [ 24 - 26 ]. In a meta-analysis of individual patient data from these trials, it was found that adjunctive low-dose MTX reduced both relapse risk and corticosteroids exposure, though the frequency and severity of AEs were not reduced [ 2728 ].
Similar beneficial effects were observed to reduce corticosteroids dose and a reduction in relapses [ 23 ]. Based on a systematic analysis of clinical trial data, the use of MTX as a steroid-sparing strategy may be considered for patients at high risk for corticosteroid-induced AEs at disease outset. It may also be useful for patients whose disease course is protracted and who are at risk for recurrent relapses and corticosteroid-induced AEs [ 2930 ].
No significant difference was shown between the groups. However, the patient group was small which limits the generalisation of this finding. Additionally, there was no randomisation to the treatment group; treatment choice was based on clinician preference. A two-centre retrospective study was designed to describe the use of azathioprine in GCA and to evaluate its steroid-sparing effect.
Of the 28 patients included, 21 responded to the combination of azathioprine and prednisolone [ 35 ]. The mean daily dose of prednisone was Treatment cessation was required in 7 out of 10 patients who experienced azathioprine-related serious side effects. It was concluded that azathioprine may be an alternative treatment for patients with GCA requiring prolonged high dose corticosteroids therapy or developing severe corticosteroid related side effects [ 35 ].
Data from 19 patients treated with cyclophosphamide CYC were retrospectively analysed. In 15 of the 19 patients, CYC had been administered after the failure of high doses of corticosteroids, or experiencing a relapse during medium to high dose corticosteroids therapy, with or without MTX [ 36 ]. CYC was used as the initial treatment in corticosteroid naive patients 4 of the 19 patients. All of the participants were also diagnosed with type 2 diabetes.
During the months follow-up, 15 of the 19 patients remained in remission. Relapse occurred in 4 of the 15 patients who sustained remission, usually 12 months after CYC was ceased. Ten adverse events were registered in nine patients, with recovery soon after the suspension of CYC or dose reduction [ 36 ]. However, one death occurred due to acute hepatitis. The disappearance of inflammatory infiltrate was demonstrated in one patient when temporal artery biopsy was repeated 3 months after CYC therapy.
This study concluded that CYC could represent a useful option for patients requiring prolonged medium- to high-dose of corticosteroid therapy and at high risk of corticosteroids-related side effects A systematic review [ 37 ] was conducted to evaluate the efficacy and safety of infliximab and etanercept in LVV.
Abatacept, a selective T cell co-stimulation modulator [ 38 ], was recently evaluated in a multicentre, randomized, double-blind phase 2 trial of 49 patients with GCA who received a standardized prednisone tapering regimen [ 20 ]. Additionally, those with large-vessel involvement underwent MRI of the aorta and branches initially and at 6-month intervals. Despite the small number of patients with large-vessel involvement in this study population, the findings suggest that abatacept may be an efficacious treatment option for reducing relapse in patients with GCA, but comparative studies will be required to determine its place in therapy.
Interleukin IL -6 contributes to the pathogenesis of GCA and represents a possible target for therapy. The mean follow-up of this cohort since diagnosis was 37 months. Out of all the patients who received TCZ, 7 patients were in disease remission until the end of follow-up for a mean time of It was concluded that TCZ led to a significant decrease in the flare rate and requirement for corticosteroid use in the study sample. GiACTA, a randomized, double-blind, placebo-controlled trial, evaluated TCZ effectiveness in achieving sustained, corticosteroid -free remission.
This was the first trial to employ a blinded, variable-dose corticosteroid-tapering regimen [ 38 ]. The study concluded that TCZ was not only highly effective in maintaining disease remission induced by the combination of TCZ and prednisone, but also that IL-6R blockade has a pronounced steroid-sparing effect for patients [ 41 ].
The trial had 4 arms: 1 TCZ SC mg weekly plus 6-month prednisone taper; 2 TCZ SC mg every other week plus 6-month prednisone taper; 3 prednisone only at 6-month taper; and 4 prednisone only at month taper. Anterior ischemic optic neuropathy developed in one patient in the group that received TCZ every other week [ 31 ]. Table 1 summarizes all agents used for steroid-sparing and the type of evidence available and recommendation for steroid-sparing in GCA.
At the time of writing, there was no British Society for Rheumatology guidance although this may be revised soon. We analysed 13 studies Table 2. There were two studies that did not support the additive value of the use of steroid-sparing agents. Five studies concluded that due to their small sample size, they recommend conducting further larger studies and 11 studies concluded that there was significant value to the use of steroid-sparing agents in side-effect reduction and clinical outcomes improvement.
Considering all the evidence available for choosing the most appropriate steroid-sparing agent in GCA, a large number of studies favoured TCZ. There is good evidence that it can safely be used for:.
The next best agent for steroid-sparing effect appears to be MTX. There is good quality evidence that supports the use of MTX to reduce flares in relapsing GCA and help in reducing the corticosteroid dose and adverse effects. Immunosuppressants like azathioprine, mycophenolate, and cyclophosphamide may be used in refractory GCA or large vessel vasculitis patients as third-line agents. His major research interests include inflammation, fibrosis, genetics and autoimmunity in scleroderma, ankylosing spondylitis, rheumatoid arthritis, osteoarthritis and other rheumatic diseases.
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❾-50%}Combined treatment of giant cell arteritis with methotrexate and prednisone -
Patients: 42 patients with new-onset giant-cell arteritis according to biopsy. Intervention: High initial doses of corticosteroid were given; the dose was then tapered quickly until therapy was completely withdrawn. Methotrexate or placebo was given weekly from the start of corticosteroid therapy for 24 months. Measurements: Number of relapses, cumulative dose of corticosteroid, and number of adverse events were assessed on completion of follow-up.
Overall, the rate and severity of adverse events were similar between groups. Treatment was discontinued in 3 patients in the methotrexate group who experienced definite drug-related adverse events. In sensitivity analysis that included patients lost to follow-up, differences between groups in number of relapses and cumulative dose of prednisone were significant. Porto University create scientific, cultural and artistic knowledge, higher education training strongly anchored in research, the social and economic valorization of knowledge and active participation in the progress of the communities in which it operates.
The Open Rheumatology Journal is an Open Access online journal, which publishes research articles, reviews, letters, case reports and guest-edited single topic issues in all areas of rheumatology. Bentham Open ensures speedy peer review process and accepted papers are published within 2 weeks of final acceptance. The Open Rheumatology Journal is committed to ensuring high quality of research published.
We believe that a dedicated and committed team of editors and reviewers make it possible to ensure the quality of the research papers. The overall standing of a journal is in a way, reflective of the quality of its Editor s and Editorial Board and its members. The Open Rheumatology Journal is seeking energetic and qualified researchers to join its editorial board team as Editorial Board Members or reviewers.
The essential criteria to become Editorial Board Members of The Open Rheumatology Journal are as follows: Experience in rheumatology with an academic degree.
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The papers published are of high quality after rigorous peer review and they are Indexed in: major international databases. I read Open Access journals to keep abreast of the recent development in my field of study. Researchers, faculty members, and students will be greatly benefited by the new journals of Bentham Science Publishers Ltd. Peer Review Workflow Reviewers Guidelines. Guidelines for Guest Editors. Article Information. Abstract Background: Giant cell arteritis is the commonest form of medium-to-large vessel vasculitis, requiring long-term corticosteroid therapy.
Materials and Methods: Various agents used in place of or in combination with corticosteroids to reduce corticosteroid-related side effects were reviewed. Variations in the Optimal Treatment Strategies for GCA In a large, representative cohort of real-world patients seen in routine clinical practice of rheumatologists across the United States of America, treatment patterns were reviewed using data from electronic medical records and other sources in an ongoing and continuous updating manner.
Relapsing and Refractory GCA The traditional view of GCA as a corticosteroid-responsive disease is not always accurate or predictable; a spectrum of severity and extent exists. Azathioprine A two-centre retrospective study was designed to describe the use of azathioprine in GCA and to evaluate its steroid-sparing effect. Cyclophosphamide Data from 19 patients treated with cyclophosphamide CYC were retrospectively analysed.
Abatacept Selective T cell Co-Stimulation Modulator and Steroid-Sparing in GCA Abatacept, a selective T cell co-stimulation modulator [ 38 ], was recently evaluated in a multicentre, randomized, double-blind phase 2 trial of 49 patients with GCA who received a standardized prednisone tapering regimen [ 20 ]. Table 1. Agents used for steroid-sparing in GCA treatments. Serial No.
There is good evidence that it can safely be used for: Steroid-sparing Induction of remission Maintenance of remission Less frequent flare-ups The next best agent for steroid-sparing effect appears to be MTX.
Table 2. List of studies included in the systematic review. Citation Sample Type Results Direct Quotation Disagree with the value adding of steroid sparing agents Agree with the value adding of steroid sparing agents More research required Z.
Su, V. Menon, R. Gliklich, T. Median follow up time was 24 months with a mean of 12 rheumatology ambulatory encounters. Henes, A. Wagner, J. Loock, W. There were also 2 case reports on autologous stem cell transplantation. A distinction between GC-resistant and GC-dependent cases could not be made from the data available. Whereas almost all case reports and retrospective case series with the exception of CSA revealed steroid-sparing effects, the 3 prospective randomised trials and 2 open prospective controlled trials on MTX gave conflicting results.
However, a recent meta-analysis which recalculated the original data resulted in superiority of MTX after 24 months, there were less relapses and lower GC doses in the MTX group. The prospective controlled ETA trial, which comprised 17 GCA patients, showed small, non-significant advantages but was too small to draw definite conclusions.
Hoffman, M. Cid, D. Hellmann, et al. The incidence of treatment failure was comparable between groups after 12 months: In a Cox regression analysis, MTX was not associated with a reduced risk of treatment failure relative risk 0. There were no significant differences between groups with regard to abnormal elevations of the erythrocyte sedimentation rate following initial remissions, serious morbidity due to GCA, cumulative CS dose, or treatment toxicity.
Jover, C. Hernandez-Garcia, I. Morado, et al. One patient in the methotrexate group and 2 in the placebo group were lost to follow-up. All patients responded to initial treatment. Moreover, fewer relapses involving cranial symptoms occurred among patients in the methotrexate group than among the control subjects 2 v. The median duration of prednisone treatment was significantly shorter in the methotrexate group than in the placebo group 29 v. There was a trend toward a lower incidence of diabetes mellitus 3 v.
Three patients receiving methotrexate experienced myelosuppression or mucositis that necessitated withdrawal of the drug. Of these, 1 patient was not taking folic acid supplementation and 2 had mild renal impairment R. Spiera, H. Mitnick, M. Kupersmith, et al.
Baseline characteristics age, height, weight, sedimentation rate, bone mineral density, total corticosteroid dose prior to randomization, and quality of life as measured by SF and function as measured by AIMS were comparable between groups.
There was no late vision loss in either group, and only one major treatment-responsive relapse in a methotrexate-treated patient. There were few major corticosteroid-related side effects and these did not significantly differ between groups. Mahr, J. Jover, R. Spiera, et al. The mean duration of follow-up was Accordingly, a predicted 3. Dropout rates and occurrence of adverse events did not differ between treatment groups. Buttgereit, C. Dejaco, E. Matteson, B.
Journal of American Medical Association, vol , pp , The diagnosis of PMR is based on clinical features such as new-onset bilateral shoulder pain, including subdeltoid bursitis, muscle or joint stiffness, and functional impairment. Headache and visual disturbances including loss of vision are characteristic of GCA. In GCA, temporal artery biopsy remains the standard for definitive diagnosis.
Glucocorticoids remain the primary treatment, but the optimal initial dose and tapering treatment regimens are unknown. According to consensus-based recommendations, initial therapy for PMR is prednisone, Smith, K. Kuet, R. Kilding, M. Akil, J. Mean age at diagnosis was 68; range 21 to The AOC for prednisolone and CRP were not normally distributed across the cohort, and non-parametric methods were therefore used for comparisons. Median AOC prednisolone dose for the prednisolone only group was Sciascia, D.
Piras, S Baldovino, et al. MMF was well tolerated, and no signs of toxicity were observed in a mean of Boureau, P. Espitia, L. De Decker, C. Mean daily dose of prednisone were Ten patients experienced azathioprine serious side effects, leading to discontinuation of treatment in seven cases. Quartuccio, M. Maset, G. De maglio, et al. Ten adverse events were registered in nine patients, with recovery usually soon after the suspension of CYC or dose reduction.
Disappearance of the inflammatory infiltrate could be demonstrated when temporal artery biopsy was repeated 3 months after CYC in one patient. Silva, E. Loza, V. Rituximab was the most used agent, having demonstrated efficacy for remission induction in patients with AAV.
A few uncontrolled studies on the use of abatacept, alemtuzumab, mepolizumab, and tocilizumab were found. Unizony, B. Keroack, J. Eight subjects had failed at least one immunosuppressant methotrexate, azathioprine, cyclophosphamide, infliximab, adalimumab and etanercept , and four had contraindications for the use of GC.
Before and during IL-6R blockade, the patients experienced an average of 2. On TCZ, 7 subjects maintained disease remission until the end of follow-up for a mean time of The mean prednisone dose at the time of disease flare in these 5 patients was 4. One subject relapsed after TCZ discontinuation. Autopsy on one patient who died from an unrelated cause revealed persistent vasculitis.
Stone, K. Tuckwell, S. Dimonaco S et al. Anterior ischemic optic neuropathy developed in one patient in the group that received tocilizumab every other week. Temporal arteritis and polymyalgia rheumatica. Clinical and biopsy findings. Ann Intern Med ; 77 6 : CrossRef PubMed. View Editorial Board.
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Join Our Editorial Board News release date: March 29, Description: The Open Rheumatology Journal is an Open Access online journal, which publishes research articles, reviews, letters, case reports and guest-edited single topic issues in all areas of rheumatology. Centre Antipoison-Centre de Pharmacovigilance, France. UCB S. Westat, USA. University of Oxford, UK.
Almac Sciences, Northern Ireland. Delft University of Technology, The Netherlands. Sapienza - University of Rome, Italy. Paris University, France. Instituto de Agroquimica y Tecnologia de Alimentos, Spain. University Clinic of Navarre, Spain. University of Vienna, Austria. Chiba University, Japan. National Central University, Taiwan. Etanercept can be used as second-line agent for induction of remission for corticosteroid refractory GCA. Sixty-four publications were found.
Twenty-one patients received prednisone and methotrexate and 21 received prednisone and placebo. Of these, 1 patient was not taking folic acid supplementation and 2 had mild renal impairment. Twenty-one patients were enrolled, 12 randomized to methotrexate, 9 to placebo. The combined data set comprised patients, of whom 84 received MTX and 77 received placebo. All three patients showed clinical benefit, and were also able to taper steroid use to a more rapid regimen compared with the recently suggested steroid reduction approach.
Of the 28 patients included, 21 responded to azathioprine. The efficacy of CYC was observed in 15 of the 19 patients, and remission was still present months after CYC suspension in 12 of the 13 patients. Of citations, abstracts, and hand-searched studies screened, 90 were included. The mean follow-up of this cohort since diagnosis was 37 months range 17— Trends in incidence and clinical presentation of temporal arteritis in Olmsted County, Minnesota, Arthritis Rheum ; 31 6 :
Polymyalgia rheumatica, a syndrome characterized by proximal muscle pain and stiffness in older persons, generally is treated with prednisone Deltasone. Dosages of 15 to 25 mg of prednisone per day can reduce inflammation considerably, although many patients relapse when therapy is tapered.
Long-term 18 to 36 months steroid treatment has been recommended by several studies, but this can result in multiple side effects, including osteoporosis, hypertension, cataracts, and hyperglycemia.
Methotrexate Rheumatrex has been used to reduce inflammation in rheumatoid arthritis, systemic vasculitis, and giant cell arteritis, and in small studies has been combined with prednisone to treat polymyalgia rheumatica, decreasing the duration of treatment.
Caporali and associates conducted a multicenter, double-blind, randomized controlled trial to evaluate the efficacy of methotrexate when combined with prednisone in the wide-scale treatment of polymyalgia rheumatica. Seventy-two patients with polymyalgia rheumatica and no contraindications to prednisone or methotrexate were given prednisone at a daily dosage of 25 mg for four weeks, tapering to In addition, patients were randomly assigned to receive methotrexate 10 mg per week or placebo.
Relapses were treated by resumption of the dose of the previous period. After 24 weeks, prednisone treatment was discontinued.
All participants received a weekly dose of folinic acid 7. Patients were assessed regularly during the 76 weeks of the study. Medications were withdrawn from patients if there was a significant decrease in their leukocyte or platelet count or a significant increase in their serum creatinine or transaminase levels.
At the end of the study, 32 patients 89 percent in the methotrexate group and 30 83 percent in the placebo group were available for evaluation. More patients in the methotrexate group were free of steroids after 76 weeks than in the placebo group, even when the worst-case scenario was assumed for those who dropped out.
The efficacy of methotrexate was clear after 48 weeks, and the methotrexate patients also had significantly fewer flare-ups.
Adverse reactions were not significantly different between the two trial groups. The authors conclude that using prednisone and methotrexate together to treat polymyalgia rheumatica can decrease the number of flare-ups and reduce the total dosage of prednisone required to achieve and maintain remission. Considering the potential adverse effects of long-term prednisone therapy, this would be advantageous to all patients, especially those who cannot tolerate high doses of prednisone.
Further studies are needed to determine whether methotrexate is effective as an induction therapy for polymyalgia rheumatica, and whether it can lower the initial dose of prednisone needed for treatment and control. Even in the Caporali study, doubt is cast on the efficacy of methotrexate because the methotrexate group had fewer flare-ups during weeks 48 to 76 when they were no longer taking methotrexate, and the likelihood of methotrexate having such a sustained effect is low.
Also, the absence of increased steroid morbidity in the higher-dose prednisone plus placebo group makes the clinical significance of this minimal prednisone dose reduction unclear. Lastly, the lack of difference in disease flare-ups during the first 24 weeks when all participants were taking prednisone, and the occurrence of flare-ups in the methotrexate group after prednisone was withdrawn, seems to demonstrate that this effectiveness was caused by prednisone alone rather than the combination.
Perhaps the continuation of the lowest effective dose of prednisone 5 mg or less would be the best and simplest treatment. Stone concludes that methotrexate may be useful for patients who do not tolerate even low doses of glucocorticoids, but the combination requires further study.
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Results: Compared with combined prednisone and placebo therapy, treatment with prednisone and methotrexate reduced the proportion of patients. Combined treatment of giant-cell arteritis with methotrexate and prednisone. A randomized, double-blind, placebo-controlled trial. February Therefore, in many patients, the combined use of slow- acting immunomodulatory drugs, such as methotrexate (MTX) or some biologic agents, is. We do not use lower doses of glucocorticoids (ie, prednisone <40 mg/day) as initial therapy in any patients with newly diagnosed GCA. In. giant cell arteritis) were initially treated using prednisone ( mg daily). once weekly in combination with daily low-dose predni-. Rheumatology Oxford ; 54 3 : International Network for the Study of Systemic Vasculitides. Join Our Editorial Board News release date: March 29, Description: The Open Rheumatology Journal is an Open Access online journal, which publishes research articles, reviews, letters, case reports and guest-edited single topic issues in all areas of rheumatology. Relapses were treated by resumption of the dose of the previous period. Chitale S, Moots R.Background: Corticosteroids remain the cornerstone of therapy for giant-cell arteritis, but relapse during dose tapering and corticosteroid-related adverse events often complicate management of this condition.
Although several approaches, including combined therapy with cytotoxic agents, have been suggested to overcome these problems, no study has clearly shown benefits of alternate treatments. Objective: To analyze the safety and efficacy of combined therapy with corticosteroids and methotrexate in giant-cell arteritis. Design: Randomized, double-blind, placebo-controlled trial. Setting: University-based clinic.
Patients: 42 patients with new-onset giant-cell arteritis according to biopsy. Intervention: High initial doses of corticosteroid were given; the dose was then tapered quickly until therapy was completely withdrawn. Methotrexate or placebo was given weekly from the start of corticosteroid therapy for 24 months. Measurements: Number of relapses, cumulative dose of corticosteroid, and number of adverse events were assessed on completion of follow-up. Overall, the rate and severity of adverse events were similar between groups.
Treatment was discontinued in 3 patients in the methotrexate group who experienced definite drug-related adverse events. In sensitivity analysis that included patients lost to follow-up, differences between groups in number of relapses and cumulative dose of prednisone were significant.
Conclusions: Treatment with methotrexate plus corticosteroid is a safe alternative to corticosteroid therapy alone in patients with giant-cell arteritis and is more effective in controlling disease. Abstract Background: Corticosteroids remain the cornerstone of therapy for giant-cell arteritis, but relapse during dose tapering and corticosteroid-related adverse events often complicate management of this condition.
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