SIMPONI® (golimumab) found to have higher treatment persistence rates in France than adalimumab, etanercept and certolizumab pegol in overall rheumatic disease population at 12 months1
Real-world data across Europe also show improvements in cost-utility and patient-reported quality of life measures with golimumab2-7
Washington, D.C., 12th November, 2016 – MSD (Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada), today announced large-scale, real-word data from studies in multiple European countries, presented at the annual American College of Rheumatology Meeting (ACR 2016). The data show long-term treatment persistence, clinical effectiveness and improvements in quality of life and related reductions in healthcare utilisation in patients treated with golimumab for ankylosing spondylitis (AS), psoriatic arthritis (PsA), and rheumatoid arthritis (RA), collectively referred to as immune-mediated rheumatic disease (IMRD).1-6
Real world treatment persistence data in 11,729 patients
A large real-world study of 11,729 IMRD patients in France (4,750 patients with RA, 5,735 with AS and 1,244 with PsA) initiating treatment with a subcutaneous tumor necrosis factor-alpha inhibitor (SC-TNFi) demonstrated that, for the overall cohort of IMRD patients, persistence over 12 months was different between the four SC-TNFi observed, with highest overall persistence seen with golimumab (60.2%) compared with adalimumab, etanercept and certolizumab pegol (57.2%, 56.4% and 59.1%, respectively).1
Within specific indications, persistence rates were highest for patients treated with golimumab in the AS cohort compared with adalimumab and etanercept (statistically significant), and in the RA cohort compared with adalimumab, etanercept and certolizumab pegol (not statistically significant). For the PsA cohort, persistence rates were second highest with golimumab and the highest with adalimumab (not statistically significant).1
The study objective was to describe treatment persistence in a real-world setting among patients diagnosed with IMRD, initiating treatment with an SC-TNFi in France and who were naïve of biologic therapies (subcutaneous and intravenous) in the last 18 months.1
Professor Bruno Fautrel, Study Investigator, Head of Rheumatology Department at the Pitié-Salpêtrière University Hospital, Paris, France, commented “The study is central for French rheumatologists since it provides a comprehensive view of TNF-blocker maintenance in real life settings, and actually it confirms the benefits that we may expect from these treatments in daily practice. For rheumatologists of other countries, the experience in a public health care system covering approximately 60-million population is also of high value.”
Both clinical and quality-of-life improvements were also observed with golimumab in a real-life study of 963 biologic-naïve patients with AS over six months (78% treated with golimumab, 22% treated with infliximab), with associated effect on health care resource utilisation.2,3 Highlights in the data include a reduction in patients reporting hospitalisations from 13.6% in the 3 months before study start to 3.1% at 6 months, and a reduction in reported outpatient care from 39.4% of patients to 19.0% at 6 months.3 Associated reductions in number of work days missed and work impairment due to AS are also reported.3
“We were pleased to see the mounting real-world evidence that choosing golimumab leads to positive outcomes for the patients and for the health systems in which it is being used. This clinical effectiveness and these quality of life benefits were demonstrated in the data presented at ACR”, said George Philip M.D., Executive Director of Clinical Research at MSD. “Furthermore, it was interesting to note that monthly dosing had a very low rate of patient non-adherence in RA patients in the ARCO study data because good adherence by patients can support continued treatment persistence over time.”
Further data on golimumab presented at ACR:
The ARCO Study (Spain) demonstrated that nonâ€‘adherence with subcutaneous biological medications in RA patients was more frequent in patients with weekly administration (17.4%) and less frequent in those with monthly administration (6.4%).4
In GO-NICE (Germany), golimumab demonstrated clinical effectiveness with associated patient-reported improvements across a wide range of quality of life and socio- and health-economic measures in 1,458 patients with RA, PsA, and AS.5 Significantly improved measures were functional ability (p<0.0001 vs baseline) and fatigue (p<0.0001 vs baseline), while other improved measures were reduced days of work absenteeism, increased productivity, and reduced requirement for hospitalisation and physiotherapy.5
In GO-MORE (Germany), further clinical effectiveness data in RA patients treated with golimumab was also presented at ACR in a sub-analysis of the GO-MORE study.6 GO-MORE was a large, open-label, multinational, prospective study in biologic-naïve patients with active RA. This analysis in 370 patients in Germany assessed the efficacy of golimumab as an add-on therapy in combination with methotrexate at different doses as well as other DMARD-combinations.6 Patients showed continuous clinical improvement rates over 6 months when treated with golimumab, regardless of the chosen concomitant therapy.6 These results, as well as quality of life and safety data were comparable to the multinational GO-MORE study.6,7
For further information, please contact:
Harry Brady (MSD) Rebecca Aris (Pegasus)
+44 (0) 7974 444 851 +44 (0) 1273 712 034
About the studies
French persistence study with TNF-Alpha inhibitor treatment
The objective of this study was to describe treatment persistence in a real-world setting, among patients diagnosed with IRMD, initiating treatment with an SC-TNFi in France and who were naïve of biotherapies (subcutaneous and intravenous) in the last 18 months.1
The Système National d’Information Inter-régime [French national health insurance scheme information-sharing system] (SNIIR-AM) database lists all outpatient and inpatient healthcare consumption for individuals covered by the general health insurance scheme. Using French claims data, patients were included through Long Term Disease (LTD) status and hospital admission, based on ICD-10 codes. Identification of RA was based on M05, M06, M08.0, M08.2, M08.4 and M13 ICD-10 codes. For AS, identification was based on M08.1, M08.8, M08.9, M45 and M46 to M14 ICD-10 codes, and identification of PsA was based on M07 and M09 ICD-10 codes. Patients were then identified through filled prescriptions for adalimumab (ADA), etanercept (ETA), certolizumab pegol (CZP) and golimumab (GLM) between 06/01/2012 and 12/31/2013. Persistence was estimated using Kaplan Meier analysis.1 A total of 4,750 patients with RA were identified, 5,735 with AS and 1,244 with PsA.1
This study was funded by MSD, who were involved with the writing, study design, analysis, and interpretation of data.
The multi-country observational study in AS patients (QUO-VADIS Study)
This was a prospective observational study in biologic-naive AS patients (modified New York criteria) newly treated with golimumab or infliximab (originator, 78% treated with golimumab, 22% infliximab) in a clinical practice setting. Patients were followed-up for ~6 months of treatment with golimumab or infliximab and data was collected at baseline (BL), and at 3 and 6 months. 2,3 The assessment of HCRU was done by evaluating data on the use of concomitant medications, hospitalisations (inpatient care or acute care) and visits in day care and outpatient settings. Work productivity and activity impairment (WPAI) was assessed by the number of work days missed as well as quantifying absenteeism, presenteeism, work impairment, and activity.3 The Classification and Regression Trees (CART) analysis evaluated the association of BL parameters (demographic, clinical, disease severity) with change in HRQoL at 6 months, measured by an improvement of ≥ 5 points of the Short-Form 36 (SF-36) Physical Component Summary (PCS) score. Clinical parameters included Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and AS Disease Activity Scores (ASDAS).2
This study was funded by MSD, who were involved with the writing, study design, analysis, and interpretation of data.
The ARCO study
ARCO was a retrospective study in RA patients ≥18 years old from 42 Spanish hospitals, who started a new SC biological drug 12 to 18 months prior to the study visit. Adherence was evaluated through the Medication Possession Ratio (MPR) (number of days covered by the taken medication / days of study period). The number of days covered was calculated with the vials taken by the patient from the hospital pharmacy, taking into account the prescribed interval of administration, changes in this interval and if induction was prescribed. The number of days was the study period, subtracting drug suspension periods. Patients with MPR ≤ 80% were considered non-adherent. Variables associated with non-adherence were studied in a multivariable model that included age, gender, RA duration, interval of administration, induction, order of administration, and changes in the interval of administration. A total of 364 patients were included (age 54.9 years [12.5]; 77.5% women, median RA duration 7.8 years). The initial interval of administration was weekly (44.2%), biweekly (39.1%) and monthly (17.3%); the median duration of the period studied 14.8 months.4
This study was funded by MSD (Merck & Co., Inc., Rahway, NJ, USA), who were involved with the writing, study design, analysis, and interpretation of data.
The German non-interventional study (GO-NICE)
Patients were enrolled in the non-interventional prospective study GO-NICE at 158 German sites to explore the disease activity by DAS28, PsARC and BASDAI, the quality of life, fatigue, days of sick leave, quality of work, as well as safety, over a 24-month period. 5
This study was funded by MSD, who were involved with the writing, study design, analysis, and interpretation of data.
The German non-interventional study (GO-MORE)
GO-MORE was a large open-label, multinational, prospective study in biologic-naïve patients (pts) with active RA. The German subpopulation (GER) analysis (n=370) was analysed in the context of the total study population (TSP, n=3.280; including GER) – purely descriptively as no formal comparison was performed. Good/moderate EULAR-(DAS28-ESR)-response depending on different DMARD-combinations and quality of life were evaluated. Enrolled pts (DAS28-ESR ≥3.2 despite DMARD-therapy) received 50mg GLM SC once monthly for 6 months.6,7
About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic inflammatory disorder that occurs when the immune system attacks the lining of the membranes that surround joints, also known as the synovium. Unlike the wear-and-tear damage associated with other types of arthritis, rheumatoid arthritis causes painful swelling and can eventually result in bone erosion and joint deformity. Rheumatoid arthritis can be difficult to diagnose in its initial stages because the early signs and symptoms mimic those of many other diseases. Currently, there is no single blood test or physical finding to confirm the diagnosis.8 It is estimated that 0.3 to 1 percent of the world’s population are living with rheumatoid arthritis. The disease is most common in women and is more prevalent in developed countries. It tends to strike during the most productive years of adulthood, between the ages of 20 and 40.9
About Psoriatic Arthritis
Psoriatic arthritis, a type of inflammation that occurs in about 15 percent of patients who have a skin rash called psoriasis, is a chronic arthritis that can lead to joint damage.10
Psoriatic arthritis can affect any joint in the body, and it may affect just one joint, several joints or multiple joints. It typically affects the large joints, especially those of the lower extremities, distal joints of the fingers and toes, and also can affect the back and sacroiliac joints of the pelvis.10
Psoriatic arthritis symptoms flare and subside, vary from person to person, and even change locations in the same person over time.10
Both men and women are equally affected by psoriatic arthritis, most commonly between the ages of 30 and 50.10
About Ankylosing Spondylitis
Axial spondyloarthritis is a painful and potentially progressive form of inflammatory arthritis that mainly affects the spine and pelvic joints, and most commonly results in chronic lower back pain.11 It typically begins in the late teens and early twenties and in severe cases can result in complete fusion of the spinal vertebrae and cause structural damage to hips and other joints.11 The term axial spondyloarthritis covers both non-radiographic axial spondyloarthritis and ankylosing spondylitis.12 In patients with ankylosing spondylitis x-ray changes are clearly present.12
Axial spondyloarthritis is a systemic inflammatory disease that, in addition to its effect on the spine, can affect other areas such as peripheral joints, eyes, and the bowel. 11
About Simponi (golimumab)
Simponi is a human monoclonal antibody that forms high-affinity, stable complexes with both the soluble and transmembrane bioactive forms of human tumour necrosis factor (TNF)-alpha.13 Simponi is a subcutaneous (SC) anti-tumor necrosis factor (TNF)-alpha treatment, available either through the Simponi™ SmartJect pre-filled pen or a prefilled syringe as a SC administered injection.13
Simponi is approved for the treatment of moderate to severe, active rheumatoid arthritis in adults, in combination with methotrexate, when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including methotrexate has been inadequate; severe, active and progressive rheumatoid arthritis, in combination with methotrexate, in adults not previously treated with methotrexate; active and progressive psoriatic arthritis in adult patients, alone or in combination with methotrexate, when the response to previous DMARD therapy has been inadequate; severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy; for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs); and in combination with methotrexate for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with methotrexate.13
In rheumatoid arthritis (RA), Simponi 50 mg is given once a month, on the same date each month. Simponi should be given concomitantly with MTX. In psoriatic arthritis (PsA), ankylosing spondylitis (AS), or non-radiographic axial spondyloarthritis (nr-Axial SpA), Simponi 50 mg is given once a month, on the same date each month. For these indications, available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period. For these indications, in patients with RA, PsA, AS, or nr-Axial SpA with a body weight of more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse drug reactions with the 100 mg dose compared with the 50 mg dose (see section 4.8). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100 mg.
Janssen Biotech, Inc. discovered and developed Simponi and markets the product in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific.
In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to Simponi to Mitsubishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights for Simponi to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Important Safety Information
SIMPONI is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis (TB) or other severe infections such as sepsis and opportunistic infections, in patients with moderate or severe heart failure (NYHA Class III/IV). Patients must be monitored closely for infections including TB, before, during and after treatment with SIMPONI. SIMPONI should not be given to patients with a clinically important, active infection. Caution should be exercised when considering use of SIMPONI in patients with a chronic infection or history of recurrent infection. Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate. Patients taking TNF-blockers are more susceptible to serious infections. Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal, and opportunistic infections, including fatalities, have been reported in patients receiving SIMPONI. Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. Administration of SIMPONI should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of treatment with SIMPONI should be carefully considered before initiation of therapy with SIMPONI.
There have been reports of TB in patients receiving SIMPONI. Patients must be evaluated for both active and inactive (“latent”) TB prior to treatment with SIMPONI (including possible previous contact with TB). Tests for TB may yield false negative results, especially in patients who are severely ill or immuno-compromised. If active TB is diagnosed, SIMPONI therapy must not be initiated. If latent TB is suspected, a physician with expertise in the treatment of TB should be consulted. If inactive (“latent”) TB is diagnosed, treatment for latent TB must be started with anti-TB therapy before the initiation of SIMPONI, in accordance with local recommendations. Prior to initiating SIMPONI, treatment for TB should be considered in patients who have several or significant risk factors for TB and a negative test for latent TB. Use of anti-TB therapy should also be considered before the initiation of SIMPONI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Cases of active TB have occurred in patients treated with SIMPONI during and after treatment for latent TB. Patients receiving SIMPONI should be monitored closely for signs and symptoms of active TB, including patients who tested negative for latent TB, patients who are on treatment for latent TB, or patients who were previously treated for TB infection.
The use of TNF-antagonists, including SIMPONI has been associated with reactivation of HBV in patients who are chronic carriers of the virus. Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with SIMPONI. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Carriers of HBV should be closely monitored for signs and symptoms of active HBV infection throughout therapy, and for several months following discontinuation of SIMPONI. In patients who develop HBV reactivation, SIMPONI should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
The potential role of TNF-blocking therapy in the development of malignancies is not known. Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy. Post-marketing cases of malignancies, some fatal, have been reported among children, adolescents and young adults (aged ≤22 years) treated with TNF-blocking agents (initiation of therapy at ≤18 years). Approximately half the cases were lymphomas. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
In the controlled portions of clinical trials of all the TNF-blocking agents including SIMPONI, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with control patients. During the SIMPONI Phase IIb and Phase III clinical trials in RA, PsA and AS, the incidence of lymphoma in patients treated with SIMPONI was higher than expected in the general population. In the post-marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist. There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation. Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. The majority of cases have occurred in adolescent and young adult males with nearly all on concomitant treatment with AZA or 6-MP for inflammatory bowel disease. The potential risk with the combination of AZA or 6-MP and SIMPONI should be carefully considered. A risk for the development for hepatosplenic T-cell lymphoma in patients treated with TNF-blockers cannot be excluded.
In the controlled portions of the SIMPONI Phase IIb and Phase III clinical trials in RA, PsA, AS, and UC, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the groups receiving SIMPONI and the control groups.
It is not known if SIMPONI treatment influences the risk for developing dysplasia or colon cancer. All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course. This evaluation should include colonoscopy and biopsies per local recommendations. In patients with newly diagnosed dysplasia treated with SIMPONI, the risks and benefits to the individual patient must be carefully reviewed and consideration should be given to whether therapy should be continued. In an exploratory clinical trial involving patients with severe persistent asthma, more malignancies were reported in patients treated with SIMPONI compared with control patients. The significance of this finding is unknown. Caution should be exercised when using any TNF-antagonist in chronic obstructive pulmonary disease (COPD) patients, as well as in patients with an increased risk of malignancy due to heavy smoking.
Melanoma has been reported in patients treated with TNF-blocking agents, including SIMPONI. Merkel cell carcinoma has been reported in patients treated with other TNF-blocking agents. Periodic skin examination is recommended, particularly for patients, with risk factors for skin cancer.
Cases of worsening- and new onset CHF have been reported with TNF-blockers, including SIMPONI. SIMPONI has not been studied in patients with CHF. SIMPONI should be used with caution in patients with mild heart failure (NYHA class I/II). Patients should be closely monitored and SIMPONI must be discontinued in patients who develop new or worsening symptoms of heart failure.
Use of TNF-blocking agents, including SIMPONI, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of CNS demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders. In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of SIMPONI therapy. Discontinuation of SIMPONI should be considered if these disorders develop.
There is limited safety experience of SIMPONI treatment in patients who have undergone surgical procedures, including arthroplasty. The long half-life should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on SIMPONI should be closely monitored for infections, and appropriate actions should be taken.
The possibility exists for TNF-blocking agents, including SIMPONI, to affect host defenses against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
The relative deficiency of TNF alpha caused by anti-TNF therapy may result in the initiation of an autoimmune process. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with SIMPONI and is positive for antibodies against double-stranded DNA, treatment with SIMPONI should be discontinued.
There have been post-marketing reports of pancytopaenia, leucopaenia, neutropaenia, aplastic anaemia, and thrombocytopaenia in patients receiving TNF-blockers. Cytopaenias including pancytopaenia have been infrequently reported with SIMPONI in clinical trials. Discontinuation of SIMPONI therapy should be considered in patients with confirmed significant haematologic abnormalities.
Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept, with no added clinical benefit. Because of the nature of the adverse events seen with this combination therapy, similar toxicities may also result from the combination of anakinra and other TNF-blocking agents. The combination of SIMPONI and anakinra is not recommended.
In clinical studies, concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections, including serious infections, compared to TNF-antagonists alone, without increased clinical benefit. The combination of SIMPONI and abatacept is not recommended.
There is insufficient information regarding the concomitant use of SIMPONI with other biological therapeutics used to treat the same conditions as SIMPONI. The concomitant use of SIMPONI with these biologics is not recommended because of the possibility of an increased risk of infection, and other pharmacological interactions.
Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse events, including infection.
Patients treated with SIMPONI may receive concurrent vaccinations, except for live vaccines. In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines, or on the secondary transmission of infection by live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections. Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for cancer) could result in clinical infections, including disseminated infections. It is recommended that therapeutic infectious agents not be given concurrently with SIMPONI.
In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following administration of SIMPONI. If an anaphylactic reaction or other serious allergic reactions occur, administration of SIMPONI should be discontinued immediately and appropriate therapy initiated. The needle cover on the pre-filled pen is manufactured from dry natural rubber, containing latex, and may cause allergic reactions in individuals sensitive to latex.
In the Phase III studies in RA, PsA, AS, and UC, no overall differences in adverse events (AEs), serious AEs, and serious infections in patients age 65 or older who received SIMPONI were observed compared with younger patients. However, caution should be exercised when treating older people, and particular attention should be paid with respect to occurrence of infections. There were no patients aged 45 and over in the nr-Axial SpA study.
Specific studies of SIMPONI have not been conducted in patients with renal or hepatic impairment. SIMPONI should be used with caution in subjects with impaired hepatic function.
SIMPONI contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take SIMPONI.
Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last SIMPONI treatment. There are no adequate data on the use of SIMPONI in pregnant women. Due to its inhibition of TNF, SIMPONI administered during pregnancy could affect normal immune responses in the newborn. Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. The use of SIMPONI in pregnant women is not recommended; SIMPONI should be given to a pregnant woman only if clearly needed. SIMPONI crosses the placenta. Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to SIMPONI in utero is not recommended for 6 months following the mother’s last SIMPONI injection during pregnancy. It is not known whether SIMPONI is excreted in human milk or absorbed systemically after ingestion. Because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after treatment with SIMPONI. No animal fertility studies have been conducted with golimumab. A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, showed no relevant effects on fertility.
In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients. The most serious ADRs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, lymphoma, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome) and haematologic reactions. Very common (≥1/10) and common (≥1/100, <1/10) ADRs reported in clinical trials and post-marketing experience with SIMPONI include: upper respiratory tract infections (nasopharyngitis, pharyngitis, laryngitis, and rhinitis), bacterial infections (such as cellulitis), lower respiratory tract infections (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess, anaemia, allergic reactions (bronchospasm, hypersensitivity, urticaria), autoantibody positive, depression, insomnia, dizziness, headache, paraesthesia, hypertension, asthma and related symptoms (such as wheezing and bronchial hyperactivity), dyspepsia, gastrointestinal and abdominal pain, nausea, gastrointestinal inflammatory disorders (such as gastritis and colitis), stomatitis, increased alanine aminotransferase and aspartate aminotransferase, pruritus, rash, alopecia, dermatitis, pyrexia, asthenia, injection-site reactions (such as injection-site erythema, urticaria, induration, pain, bruising, pruritus, irritation and paraesthesia), chest discomfort and bone fractures. Simponi® is a Registered Trademark owned by Johnson & Johnson and licensed to Merck and Co., Inc. (known as MSD outside the US and Canada), Kenilworth, New Jersey, USA.
For complete EU prescribing information, please visit www.ema.europa.eu.
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1. Belhassen M, Hudry C, Woronoff MC, et al. Treatment Persistence with Subcutaneous TNF-Alpha Inhibitors in France. Abstract 2253 presented at the American College of Rheumatology Annual Meeting 2016, Washington, November 2016. Available at http://acrabstracts.org/abstract/treatment-persistence-with-subcutaneous-tnf-alpha-inhibitors-in-france/. Last Accessed October 2016.
2. Van Den Bosch F, Flipo RM, Braun J, et al. Clinical and Quality of Life Improvements Observed with Golimumab and Infliximab in a Large Real-Life Ankylosing Spondylitis Population: results from the QUO-VADIS study. Abstract 730 presented at the American College of Rheumatology Annual Meeting 2016, Washington, November 2016. Available at http://acrabstracts.org/abstract/clinical-and-quality-of-life-improvements-observed-with-golimumab-and-infliximab-in-a-large-real-life-ankylosing-spondylitis-population/. Last accessed October 2016.
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