Effectiveness Of Golimumab Research Articles

P682 GO-CARE: a prospective multi-centre observational study of golimumab effectiveness and quality of life in a real life UC patient population in Italy

P682 GO-CARE: a prospective multi-centre observational study of golimumab effectiveness and quality of life in a real life UC patient population in Italy

Reduced Occurrence Rate of Acute Anterior Uveitis in Ankylosing Spondylitis Treated with Golimumab - The GO-EASY Study.

Acute anterior uveitis (AAU) is common in ankylosing spondylitis (AS). Golimumab (GOL), a tumor necrosis factor-α inhibitor (TNFi), has proven to be effective in the treatment of AS. To date, the effect of GOL on the incidence of AAU in AS is unknown. The objective was to study the AAU occurrence rate in patients with AS during GOL treatment and secondarily, the efficacy of GOL in daily clinical practice. The study was a multicenter prospective study in a real-world setting in patients with AS who were treated with GOL for 12 months. The occurrence of AAU was assessed in the year before the initial TNFi treatment and during GOL treatment and calculated for the period at risk for a new AAU. Measures for disease activity [Ankylosing Spondylitis Disease Activity Score (ASDAS)] and treatment response [Assessment of Spondyloarthritis international Society (ASAS20 score)] were collected. In total, 93 patients (65% male, 55% TNFi-naive, 27% history of AAU) were included, with a median disease duration of 7 years and ASDAS score of 3.1. During GOL treatment, the AAU occurrence rate was reduced from 11.1 to 2.2 per 100 patient-years (rate-ratio 0.20, 95% CI 0.04-0.91). After 3 months of treatment, 41% of the patients experienced a clinically important improvement of the ASDAS score (p < 0.001) and 36% an ASDAS20 response (p < 0.001). At month 12, 49% had achieved an ASAS20 response (p < 0.001). In AS, the AAU occurrence rate and disease activity decreased significantly during GOL treatment. Therefore, GOL can be considered a good choice in patients with AS who need a TNFi, especially in cases of recurrent AAU. (EudraCT number: 2012-002458-21).

Golimumab effectiveness and safety in clinical practice for moderately active ulcerative colitis.

Golimumab (GLB) is an antitumour necrosis factor-α (anti-TNF) therapy that has shown efficacy as induction and maintenance therapy for ulcerative colitis (UC). We aimed to describe the outcome of GLB therapy for UC in a real-world clinical practice. Consecutive patients receiving GLB for UC in six Irish Academic Medical Centres were identified. The primary study endpoint was the 6-month corticosteroid-free remission rate. The secondary endpoints included the 3-month clinical response, time free of GLB discontinuation and adverse events. Seventy-two patients were identified [57% men; median (range) age of 41.4 years (20.3-76.8); disease duration 6.6 years (0-29.9); follow-up 8.7 months (0.4-39.2)]. Sixty-four percent of patients were anti-TNF naive. The 3-month clinical response and the 6-month corticosteroid-free remission rates were 55 and 39%, respectively. Forty-four percent of patients discontinued GLB during the follow-up, median (95% confidence interval) time to GLB discontinuation 18.7 months (9.2-28.1). A C-reactive protein more than 5 mg/l at baseline was associated with failure to achieve 6-month corticosteroid-free remission and a shorter time to GLB discontinuation, odds ratio 0.2 (0.1-0.7), P=0.008, and hazard ratio (95% confidence interval) 2.8 (1.3-5.7), P=0.007, respectively. Adverse events occurred in 7% of patients (n=5), all of which were minor and self-limiting. These real-world clinical data suggest that GLB is an effective and safe therapy for a UC cohort with significant previous anti-TNF exposure. An elevated baseline C-reactive protein, likely reflective of increased inflammatory burden, is associated with a reduced likelihood of a successful outcome of GLB therapy.

EFFECT OF GOLIMUMAB ON IMMUNOLOGICAL MARKERS FOR BONE METABOLISM AND ON ARTERIAL STIFFNESS IN PATIENTS WITH RHEUMATOID ARTHRITIS

Objective: to evaluate the effect of golimumab (GLM) on the receptor activator of NF-κB ligand (RANKL)/osteoprotegerin (OPG) transmembrane molecular system and arterial stiffness in patients with rheumatoid arthritis (RA).Subjects and methods. Thirty-six patients with RA were examined and randomized into 2 groups based on disease duration (less than or more than 2 years). The serum levels of OPG, and RANKL, were investigated. Dual-energy X-ray absorptiometry and pulse wave contour analysis were performed before and 52 weeks after GLM treatment.Results and discussion. Group 1 patients demonstrated increased serum OPG levels that were on average 3.6 times higher than in the controls (р=0.005) and 2.1 times higher than in Group 2 (р=0.01). In Group 2 patients, the RANKL concentration was 9-fold higher than that in the controls (p=0.001) and 30.6% higher than in Group 1 (p=0.01). The examinees were found to be diagnosed with subclinical damage to the great arteries (increases in augmentation index (AIp), stiffness index (SI), and reflection (RI) index), which progressed with a longer RA duration. After GLM treatment, serum OPG and RANKL levels decreased in Group 1 patients by 2.1- (p&lt;0.001) and 1.7-fold (p&lt;0.01), respectively. In Group 2, the level of RANKL dropped by 32.2% (p&lt;0.01), without significant OPG concentration changes. After GLM treatment, the pulse wave contour analysis parameters in Group 1 did not differ from those in the controls; Group 2 showed significant decreases in AIp by an average of 1.8 times (p&lt;0.01), in SI by 1.2 times (p&lt;0.01), and in RI by 1.6 times (p&lt;0.01).Conclusion. GLM treatment in RA patients is accompanied by a lower imbalance in the RANKL/OPG transmembrane molecular system and exerts a vasoprotective effect on the large elastic vessels (reductions in AIp and SI) and small muscular arteries (a decrease in RI).

THE EFFECT OF GOLIMUMAB ON ARTERIAL STIFFNESS IN PATIENTS WITH RHEUMATOID ARTHRITIS

Objective: to evaluate the effect of golimumab (GLM) on arterial stiffness in patients with different clinical and immunological subtypes of rheumatoid arthritis (RA). Material and methods. Examinations were made in 48 patients with RA meeting the 1987 ACR/2010 EULAR classification criteria. The investigators visualized carotid arteries with determination of local vessel wall stiffness and studied regional arterial stiffness with assessment of contour pulse wave analysis before and 52 weeks after initiation of therapy. Results and discussion . Young and middle-aged RA patients without any concomitant cardiovascular diseases were found to have subclinical great artery involvement that was characterized by increases in intima-media thickness (IMT) and stiffness index β of the common carotid artery (CCA); by rises in peripheral augmentation index (AIp), stiffness index (SI), and reflection index (RI), the intensity of a change in which was associated with high DAS28 and seropositivity for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (antiCCP) antibodies. GLM treatment in patients with RA was accompanied by a statistically significant decrease in DAS28 and a reduction in CCA IMT and local (carotid) stiffness of the vascular bed. More significant correction of the investigated parameters was achieved in patients with the seronegative subtype of the disease; in this group of patients, CCA IMT decreased by 29% by the end of observation (p=0.01), CCA SI β reduced by an average of 28.7% (p=0.0001). At 52 weeks after GLM therapy initiation, contour pulse wave analysis indicated that this subgroup of patients was observed to have decreases in AIp, SI, and RI to the control level; in RA seropositive for RF and/or anti-CCP, they reduced by an average of 1.8 (p=0.0001), 1.2 (p=0.005) and 1.6 (p=0.001) times, respectively. Conclusion. Along with high anti-inflammatory activity, GLM therapy in patients with RA has a vasoprotective effect on the walls of large elastic-type vessels (decreases in CCA IMT and SI β, AIp, and SI) and small muscular-type arteries (a reduction in RI).

P762 GO-CARE: A prospective multi-centre observational study of golimumab effectiveness and quality of life in a real-life UC patient population in Italy

P762 GO-CARE: A prospective multi-centre observational study of golimumab effectiveness and quality of life in a real-life UC patient population in Italy

Postmarketing surveillance evaluating the safety and effectiveness of golimumab in Japanese patients with rheumatoid arthritis

Objectives: The purpose of this study was to evaluate the real-world safety and effectiveness of golimumab (GLM) in Japanese patients with rheumatoid arthritis.Methods: A postmarketing surveillance of 5154 patients was conducted with a follow-up duration of at least 24 weeks. Patients were divided into four groups based on the initial treatment: 50 mg or 100 mg of GLM with concomitant use of methotrexate (MTX) and 50 mg or 100 mg of GLM monotherapy. Patient characteristics at baseline, safety and effectiveness were assessed for each group.Results: Over 70% of patients received 50 mg of GLM with concomitant MTX, and approximately, 20% received monotherapy. The incidence rate of adverse events was 45.40 per 100 patient-years. The incidence of adverse events including serious adverse events was comparable across all groups. The proportion of patients showing remission or low disease activity increased from 13.69% to 46.21% at the final evaluation, and no differences were observed in the percentage of remission across the four groups. Concomitant MTX use was associated with higher probability of continuing therapy.Conclusions: GLM showed effectiveness in Japanese rheumatoid arthritis patients with an acceptable safety profile.

Efficacy of golimumab for preventing large joint destruction in patients with rheumatoid arthritis as determined by the ARASHI score

Objectives: The objective of this study is to investigate the inhibitory effect of golimumab on large joint destruction in patients with rheumatoid arthritis.Methods: We recruited 45 patients with rheumatoid arthritis and evaluated the radiographic severity of large joint destruction using the assessment of rheumatoid arthritis by scoring of large joint destruction and healing in radiographic imaging (ARASHI) score. We evaluated 450 large joints including the elbow, shoulder, hip, knee, and ankle at baseline and 52 weeks after treatment with golimumab. Rapid radiographic progression (RRP) and rapid radiographic improvement (RRI) were calculated and the correlation between large joint destruction and clinical factors was analyzed.Results: The mean age of the study population was 61.29 ± 14.71 years old, and most patients (91.1%) were female. The mean disease duration was 12.6 ± 12.48 years. The cohort included patients in all clinical stages of disease as defined by the Steinbroker criteria (I:7, II:10, III:9, IV:19) as well as clinical classes 2 (n = 18), 3 (n = 26), and 4 (n = 1) and the mean disease activity score-CRP (DAS28-CRP) was 4.431 ± 1.044. Patients were treated with methotrexate (mean dose 6.44 ± 1.78 mg/week), prednisolone (PSL) (mean dose 1.078 ± 1.871 mg/d), and golimumab (44.4% of 100 mg). RRP was evident in 20% of the large joints treated with golimumab, and, therefore, golimumab was effective at inhibiting large joint destruction in 80% of joints. RRI was evident in 33.3% of large joints following golimumab treatment. We also observed that EULAR response criteria significantly correlated with the ARASHI change score at 52 weeks after treatment. The total ARASHI status score significantly correlated with the Sharp–van der Heijde score, but not with the delta total sharp score. Multiple regression analyses revealed that the total ARASHI change score was only correlated with EULAR response criteria significantly.Conclusions: Golimumab therapy was effective at inhibiting large joint destruction of RA patients who have good clinical response, including higher improvement of the shoulder and ankle joints than other large joints.

Mo1902 Real World Use and Effectiveness of Golimumab for Ulcerative Colitis in Canada

Mo1902 Real World Use and Effectiveness of Golimumab for Ulcerative Colitis in Canada

P583. Real-world use and effectiveness of golimumab for ulcerative colitis in Canada

P583. Real-world use and effectiveness of golimumab for ulcerative colitis in Canada

Effect of golimumab and pamidronate on clinical efficacy and MRI inflammation in axial spondyloarthritis: a 48-week open randomized trial

Objectives: To compare the effect of golimumab (GLM) and pamidronate (PAM) on clinical efficacy and magnetic resonance imaging (MRI) inflammation in axial spondyloarthritis (aSpA).Method: Patients who fulfilled the Assessment of SpondyloArthritis Society (ASAS) criteria for aSpA and had active disease [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4] were randomized in a 2:1 ratio to receive either GLM (50 mg) or PAM (60 mg) 4 weekly for 48 weeks. Clinical efficacy was assessed at intervals. Inflammation of the spine and sacroiliac joints (SIJs) on MRI was graded by the Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system.Results: Twenty patients were assigned to GLM and 10 to PAM (83% men; age 33.4 ± 10.9 years; disease duration 4.4 ± 3.4 years). The baseline characteristics of the two groups were similar. At week 48, the proportions of patients who achieved an ASAS20 response were not significantly different between the GLM and PAM groups (65% vs. 56%; p = 0.69). Although there were no differences in BASDAI, spinal pain, and Medical Outcomes Study 36-item Short Form Health Survey (SF-36) scores between the two groups at week 48, the Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath AS Functional Index (BASFI), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) levels were significantly lower in GLM-treated patients. The SPARCC scores of the spine and SIJs decreased significantly in GLM- but not in PAM-treated patients. The differences in SPARCC scores between the two groups at week 48 were statistically significant. The frequency of adverse events (AEs) was similar in both arms.Conclusions: In patients with aSpA, the clinical response rate and improvement in pain and quality of life (QoL) were similar between GLM and PAM groups after 48 weeks. However, significant reduction in inflammatory markers and MRI inflammation was only observed with GLM treatment.

155. Incidence of Inefficacy and Side Effects of Golimumab in Rheumatoid Patients: A University Hospitals of Leicester Audit

155. Incidence of Inefficacy and Side Effects of Golimumab in Rheumatoid Patients: A University Hospitals of Leicester Audit

The effects of golimumab on subclinical atherosclerosis and arterial stiffness in ankylosing spondylitis--a randomized, placebo-controlled pilot trial

Our aim was to ascertain the efficacy of golimumab compared with placebo in the prevention of atherosclerosis and arterial stiffness in AS. A randomized, double-blind, placebo-controlled pilot study was performed in which AS patients were treated with golimumab (n = 20) and placebo (n = 21) for 12 months. Patients from the placebo group who failed to achieve a 20% response to Assessment of SpondyloArthritis international Society criteria (ASAS20) at 6 months received open-label golimumab. Intima-media thickness (IMT), pulse wave velocity (PWV) and augmentation index (AIx) were measured at baseline, 6 and 12 months. At 6 months, 11/20 (55%) and 3/21 (14%) patients from the golimumab and placebo groups achieved an ASAS20 response, respectively (P = 0.006). There was no significant difference in the change of the vascular parameters between the two groups. In the placebo group, significantly greater progression of the mean IMT [from 0.51 mm (S.D. 0.07) at baseline to 0.53 mm (S.D. 0.08) at 6 months, P = 0.044] and PWV (from 12.2 m/s (S.D. 1.6) at baseline to 12.6 m/s (S.D. 1.3), P = 0.028] were observed. There was a trend towards progression of the mean IMT in the golimumab group (P = 0.099) but the maximum IMT, PWV and AIx remained unchanged. At 12 months the changes in vascular parameters were similar between the early and delayed (or no) golimumab groups. Uncontrolled inflammation may result in a significant progression in IMT and PWV in patients with AS. Arterial dysfunction may be prevented by golimumab over a period of 6 months, probably because of effective suppression of inflammation. clinicaltrials.gov (NCT01212653)

Covering the Cover

Covering the Cover

Adverse effects of golimumab in the treatment of rheumatologic diseases

Introduction: A number of new biological immune modulators have become available as treatments for inflammatory diseases over the past two decades. Most prominent among them are TNF-α inhibitors (TNFi) which have been available in the clinic since the late 1990s. TNFi have demonstrated efficacy in various rheumatologic diseases as well as in inflammatory bowel disease and psoriasis. Golimumab is one of the most recently introduced TNFi.Areas covered: Although golimumab is generally well tolerated, as is the case with other TNFi and indeed with most of the marketed immunomodulatory drugs, potential adverse events may be associated with its use. Herein, we the potential adverse effects associated with golimumab therapy are reviewed. Adverse effects are divided into target-related and agent-related categories.Expert opinion: Golimumab has been demonstrated to be generally safe and well tolerated. Its safety profile seems to be very comparable to the other available TNFi. Long-term studies of golimumab and other TNFi will help establish the durability of response to golimumab as well as identify any potential delayed or cumulative adverse effects.

Effectiveness of Golimumab in Clinical Management of Patients with Rheumatoid Arthritis

Background and ObjectivesLimited data are available regarding the use of golimumab (100 mg) every 4 weeks, with or without methotrexate (MTX). The aim of this retrospective analysis was to evaluate the effectiveness and safety of golimumab following usual clinical practice in Japanese patients with rheumatoid arthritis (RA) according to the recommendations given in the Japanese package insert.Patients and MethodsJapanese RA patients with moderate-to-high disease activity, according to the 28-joint disease activity score based on C-reactive protein (DAS28-CRP) criteria, despite treatment with MTX or another biological agent, were enrolled. Patients were assigned to 50 mg golimumab plus MTX or 100 mg golimumab monotherapy every 4 weeks for 24 weeks. All patients were given MTX if it was not contraindicated. The primary endpoint was the proportion of patients achieving clinical remission (defined as a DAS28-CRP <2.3 or a simplified disease activity index [SDAI] score <3.3) at 24 weeks.ResultsMost patients received combined 50 mg golimumab plus MTX (41/43). In these patients, the primary endpoint, clinical remission, was attained in 83 % of patients according to DAS28-CRP criteria (p < 0.001) and 69 % according to SDAI criteria (p < 0.001) by week 24. Adverse events were reported in 11.6 % of patients receiving golimumab.ConclusionsGolimumab (50 mg) plus MTX effectively reduced the signs and symptoms of RA and was generally well tolerated in patients with an inadequate response to MTX and other biological agents.

Effects of golimumab on the dermatologic manifestations of psoriatic arthritis: 5-year results from the long-term extension of the randomized, placebo-controlled, GO-REVEAL study

Effects of golimumab on the dermatologic manifestations of psoriatic arthritis: 5-year results from the long-term extension of the randomized, placebo-controlled, GO-REVEAL study

Effect of golimumab combined with methotrexate on radiographic progression in rheumatoid arthritis: Comment on the article by Emery et al

Effect of golimumab combined with methotrexate on radiographic progression in rheumatoid arthritis: Comment on the article by Emery et al

Assessment by MRI of inflammation and damage in rheumatoid arthritis patients with methotrexate inadequate response receiving golimumab: results of the GO-FORWARD trial

ObjectiveTo evaluate golimumab's effect on MRI-detected inflammation and structural damage in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX).MethodsPatients (n=444) were randomly assigned to placebo plus MTX, golimumab 100...

New drugs: Golimumab, besifloxacin hydrochloride, and artemether/lumefantrine

Antiarthritic agent Golimumab (Simponi—Centocor Ortho Biotech) is the fifth tumor necrosis factor (TNF) blocker (inhibitor) to be marketed for the treatment of rheumatoid arthritis, joining etanercept (Enbrel), infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia). The latter agent was initially marketed in 2008 for the treatment of Crohn’s disease and was subsequently approved in May 2009 for the treatment of rheumatoid arthritis. Golimumab is a humanized monoclonal antibody that prevents the binding of TNF alpha to its receptors, thereby inhibiting its activity. Like etanercept, adalimumab, and certolizumab, golimumab is administered subcutaneously, whereas infliximab is administered intravenously. The new drug is specifically indicated for use in adult patients for the treatment of moderately to severely active rheumatoid arthritis (in combination with methotrexate), active psoriatic arthritis (alone or in combination with methotrexate), and active ankylosing spondylitis. Etanercept, adalimumab, and infliximab are also indicated for the three conditions for which golimumab has been approved, although the specifics of these indications vary in some instances. For example, in the treatment of rheumatoid arthritis, the indication for golimumab and infliximab involves use in combination with methotrexate, whereas such combination use is not required with etanercept and adalimumab (or certolizumab). The labeled indications for etanercept and adalimumab in the treatment of rheumatoid arthritis also reflect the benefits of inducing major clinical response, inhibiting the progression of structural damage, and improving physical function, and the latter two are included in the labeled indication for infliximab. In the treatment of psoriatic arthritis, the labeled indication for etanercept, adalimumab, and infliximab, but not for golimumab, includes reference to inhibiting the progression of structural damage and improving physical function. The effectiveness of golimumab in the treatment of rheumatoid arthritis was demonstrated in three controlled trials. One of these studies included patients who had been previously treated with one or more doses of another TNF blocker without a serious adverse event but who had discontinued this treatment for a variety of reasons. In all three studies, a higher percentage of patients who were treated with the combination of golimumab and methotrexate experienced improvement at the week 14 and 24 evaluation points compared with patients treated with methotrexate alone. Golimumab has not been directly compared with other TNF blockers in clinical studies, and data are not sufficient to conclude that it is effective in patients in whom response with other TNF blockers has been inadequate. In patients with psoriatic arthritis or ankylosing spondylitis, the use of golimumab resulted in significant improvement in signs and symptoms. Including methotrexate in the regimen for treating psoriatic arthritis did not provide a consistent benefit, and golimumab may be used alone or in combination with methotrexate in the treatment of this disorder. Certain of the TNF blockers have also been approved for other indications. Etanercept and adalimumab are indicated for the treatment of juvenile idiopathic arthritis, and these agents, as well as infliximab, are indicated for the treatment of plaque psoriasis. Infliximab, adalimumab, and certolizumab are indicated for the treatment of patients with Crohn’s disease, and infliximab is also indicated for the treatment of patients with ulcerative colitis. However, these are not labeled indications for golimumab currently. The risks and adverse events associated with the use of golimumab are generally similar to those of the other TNF blockers. Of greatest concern is the potential for serious infection (e.g., tuberculosis [TB], invasive fungal infections, other opportunistic infections), some of which have been fatal and which are the subject of a boxed warning in the product labeling. Treatment with golimumab should not be initiated in patients with an active infection, including clinically important localized infection. Patients should be evaluated for TB risk factors and tested for latent TB infection. A risk of reactivation of hepatitis B virus in patients who are chronic carriers of this virus also exists. The risk of serious infections is increased if a TNF blocker is used concomitantly with abatacept (Orencia) or anakinra (Kineret). Accordingly, golimumab should not be used concurrently with one of these agents. The TNF blockers have also been associated with a risk of malignancies (e.g., lymphomas). The risks and benefits of golimumab should be carefully evaluated before initiating treatment in a patient with a known malignancy or when considering whether to continue treatment in a patient who develops a malignancy. Other risks with the use of golimumab, as well as the other TNF blockers, include exacerbation or new onset of congestive heart failure, exacerbation or new onset of central nervous system demyelinating disorders (e.g., multiple sclerosis), and hematologic reactions