Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial

Abstract Background The prostaglandin D2 (PGD2) receptor 2 (DP2 receptor) pathway is an important regulator of the inflammatory cascade in asthma, which can be stimulated by allergic or non-allergic triggers. Fevipiprant is an oral, non-steroidal, highly selective, reversible antagonist of the DP2 receptor that inhibits the binding of PGD2 and its metabolites. Methods SPIRIT, a 2-treatment period (52-week, double-blind and optional 104-week single-blind), randomised, placebo-controlled, multicentre, parallel-group study, assessed the long-term safety of fevipiprant (150 mg and 450 mg o.d.) added to standard of care in patients ≥ 12 years with uncontrolled asthma. Stratified block randomisation was used. Patients were randomised in an approximate ratio of 3:3:1 (fevipiprant 150 mg, fevipiprant 450 mg or placebo). Patients were either newly enrolled or had participated in a previous fevipiprant Phase 3 trial. Primary endpoints were: time-to-first treatment emergent adverse event (AE); serious AE; and AE leading to discontinuation from study treatment. Data from both treatment periods were combined for analyses. Data were collected during study site visits. Results In total, 1093 patients were randomised to receive fevipiprant 150 mg, 1085 to fevipiprant 450 mg, and 360 to placebo. Overall, 1184 patients had ≥ 52 weeks’ treatment, while 163 received ≥ 104 weeks’ treatment. Both doses were well tolerated, with a safety profile similar to placebo both in new patients and in those enrolled from previous studies. In exploratory analyses, reduced rates of moderate-to-severe asthma exacerbations, increased time-to-first moderate-to-severe asthma exacerbation and improved FEV1 were observed for both doses of fevipiprant versus placebo; these were without multiplicity adjustment and should be interpreted with caution. SPIRIT was terminated early, on 16 December 2019, by the Sponsor. Conclusions In patients with uncontrolled asthma, the addition of fevipiprant had a favourable long-term safety profile. Trial registration Clinicaltrials.gov, NCT03052517, prospectively registered 23 January 2017, https://clinicaltrials.gov/ct2/show/NCT03052517.

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Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial

Ukrains'kyi Visnyk Psykhonevrolohii ◽

10.36927/2079-0325-v28-is3-2020-5 ◽

2020 ◽

pp. 27-37

Author(s):

Suresh Durgam ◽

Willie Earley ◽

Rui Li ◽

Dayong Li ◽

Kaifeng Lu ◽

...

Keyword(s):

Safety Profile ◽

Relapse Prevention ◽

Controlled Trial ◽

Fixed Dose ◽

Open Label ◽

Double Blind ◽

Double Blind Placebo ◽

Randomized Controlled ◽

Time To Relapse

Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97 weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3—9 mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9 mg/d) or placebo for double-blind treatment (up to 72 weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n = 99) or cariprazine (n = 101). Time to relapse was significantly longer in cariprazine — versus placebo-treated patients (P = .0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI] = 0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥ 10% of patients during open-label treatment; there were no cariprazine adverse events ≥ 10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060. Key words: schizophrenia; cariprazine; long-term treatment; relapse prevention; randomized controlled trial; oral antipsychotics

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Biologics for oral corticosteroid-dependent asthma

Allergy and Asthma Proceedings ◽

10.2500/aap.2020.41.200015 ◽

2020 ◽

Vol 41 (3) ◽

pp. 151-157

Author(s):

İnsu Yılmaz

Keyword(s):

Severe Asthma ◽

Oral Corticosteroid ◽

Real Life ◽

Severe Atopic Dermatitis ◽

Double Blind ◽

Eosinophilic Asthma ◽

Asthma Phenotype ◽

Severe Eosinophilic Asthma ◽

Term Administration

Background: Oral corticosteroid (OCS) dependent asthma is one of the severe asthma phenotypes that requires personalized treatment. Objective: To review the role of biologic treatments in OCS-dependent asthma. Methods: A nonsystematic review was performed of emerging multiple novel biologics for potential treatment of OCS-dependent asthma. Results: The serious adverse effects of OCS can be seen as a result of their regular long-term administration. Anti‐interleukin (IL) 5 (mepolizumab), anti‐IL-5R (benralizumab), and anti‐IL-4Rα (dupilumab) are the therapies of choice for OCS-dependent severe asthma. Results of studies showed the efficacy of mepolizumab, benralizumab, and dupilumab, especially in patients with the OCS-dependent severe eosinophilic asthma phenotype and with nasal polyps. Dupilumab may be the therapy of choice of monoclonal antibodies in cases of moderate-severe atopic dermatitis accompanied by OCS-dependent severe asthma. For reslizumab and omalizumab, placebo controlled double-blind studies conducted with OCS-dependent patient populations are needed. Conclusion: Biologics are effective in the “OCS-dependent asthma” phenotype as add-on therapy. It seems that chronic OCS use in OCS-dependent asthma will be replaced by biologic agents that specifically target type 2 inflammation, along with a much better safety profile. However, real-life studies that compare these biologics in OCS-dependent severe asthma are urgently needed.

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Choice of therapy and time to first treatment for patients with colon cancer: A National Cancer Database analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e14642 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e14642-e14642

Author(s):

David C. Olson ◽

Khaled Mohamed Abou El-Ezz ◽

Peter T. Silberstein

Keyword(s):

Colon Cancer ◽

Stage Iv ◽

Standard Of Care ◽

Insurance Status ◽

National Cancer Database ◽

Veteran Affairs ◽

Treatment Data ◽

Medicare Patients ◽

Time To First Treatment ◽

To Receive

e14642 Background: Insurance status has been shown to affect adherence to guidelines in the treatment of colon cancer1. This study aims to investigate trends in management of colon cancer and time to first treatment in patients with various insurance types using the National Cancer Database (NCDB). Methods: Treatment data for 845,121 patients and time to first treatment data for 497,993 patients diagnosed with colon cancer between 2000 and 2010 were identified using the NCDB. Reported utilization of treatment and time to first treatment were analyzed by insurance status. Results: Among all stages of colon cancer, no treatment was received more often by Veteran Affairs (10.5%) and Medicare (10.9%) patients than uninsured (8.8%), managed care (4.5%), private insurance (4.7%), Medicaid (8.4%) or Medicare with supplement (7.7%). Among stage I colon cancer, surgery was received less often by uninsured (90.9%) than other insurance types. Stage III colon cancer patients enrolled in Medicare with/without supplement received chemotherapy less often than other insurance types (49.9% and 46%). Stage IV Medicare patients with/without supplement also received chemotherapy less than other insurance types (59.5% and 52.9%). Surgery as monotherapy was the most common treatment received among all insurance types and stages. More uninsured patients received treatment within 3 days than any other insurance types (61%). A delay of at least 17days occurred more in Veteran Affairs patients than other insurance types (40.6%). Conclusions: This is the largest study to date to have examined treatment trends and time to first treatment. Among all insurance types, Medicare without supplement and Veteran Affairs patients were most likely to receive no treatment. Uninsured were less likely to receive the standard of care treatment with stage I cancers. Medicare patients were less likely to receive the standard of care for stage III and stage IV cancers than other insurance types. Veteran Affairs patients had treatment delayed significantly more than other insurance types. Future studies are needed to assess factors leading to receipt of substandard care.

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Antiplatelet therapy: new insights on the secondary prevention of stroke

NATIONAL JOURNAL OF NEUROLOGY ◽

10.28942/nnj.v1i2.230 ◽

2019 ◽

pp. 39-51

Author(s):

Julián García- Rafanell ◽

Javier Borja

Keyword(s):

Secondary Prevention ◽

Safety Profile ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Antiplatelet Agent ◽

Antiplatelet Agents ◽

Double Blind ◽

Long Term Study ◽

Long Term Treatment

Antiplatelet agents represent an important part of the therapeutic armamentarium in the prevention of stroke. Among them, aspirin is the gold standard but its chronic use has been associated with gastric intolerance, gastrointestinal and systemic hemorrhages and drug-resistance. Triflusal is a new antiplatelet agent from the family of salicylates but is not derived from aspirin and has a more selective mechanism of action : inhibition of thromboxane A2 in the platelet with no effect on prostacyclin biosynthesis in the endothelium. In the quest for the search of new antiplatelet agents, triflusal has shown a similar relative risk reduction than aspirin for the prevention of stroke but with reduced severe hemorrhagic side effects. The efficacy and better safety profile of triflusal vs aspirin in the secondary prevention of stroke has been demonstrated in major, randomized and double blind clinical trials and confirmed after a long term study with a mean follow up of 17 years, as well as in a Cochrane meta-analysis. Aspirin, but not triflusal, increased antihypertensive therapy requirements during long term treatment in the secondary prevention of stroke. In patients with atrial fibrillation, the combination of oral anticoagulants with triflusal has shown increased efficacy versus the standard oral single anticoagulation treatment with no increase of haemorrhagic risk. Studies have shown that the risk of upper gastrointestinal bleeding associated with the use of triflusal was negligible whereas the hemorrhagic risk associated with the use of aspirin, including low doses aspirin, was evident. Triflusal was well tolerated in asthmatic patients with aspirin-exacerbated –respiratory-diseases. The efficacy of triflusal in secondary prevention of stroke and its better safety profile when compared to aspirin has been recognized in important International Guidelines including the European Stroke Organization Guidelines.

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A 1-day visit in a severe asthma centre: effect on asthma control, quality of life and healthcare use

European Respiratory Journal ◽

10.1183/13993003.00220-2016 ◽

2016 ◽

Vol 48 (3) ◽

pp. 726-733 ◽

Cited By ~ 36

Author(s):

Akke-Nynke van der Meer ◽

Henk Pasma ◽

Wilma Kempenaar-Okkema ◽

Jo-Anneke Pelinck ◽

Myrte Schutten ◽

...

Keyword(s):

Quality Of Life ◽

Asthma Control ◽

Severe Asthma ◽

Life Questionnaire ◽

Healthcare Use ◽

Uncontrolled Asthma ◽

Control Quality ◽

Asthma Patients

Patients with uncontrolled asthma report ongoing symptoms, poor quality-of-life and extensive healthcare use (HCU) and might benefit from management by a specialised severe asthma team. It is unknown whether a one-time evaluation by asthma experts, without long-term supervision by a specialised team, provides favourable outcomes. We evaluated asthma control (Asthma Control Questionnaire; ACQ), quality-of-life (Asthma-related Quality of Life Questionnaire; AQLQ) and HCU before and 1 year after a 1-day visit programme in a severe asthma centre, including a multidisciplinary assessment resulting in a personalised management plan to be implemented by patients own pulmonologists.40 uncontrolled asthma patients completed questionnaires (ACQ, AQLQ, HCU) at baseline, and 6 and 12 months follow-up.ACQ improved from 2.6 (interquartile range 1.7–3.2) to 1.8 (1.2–3.2) (p=0.003) and AQLQ from 4.8 (4.0–5.2) to 5.3 (4.4–6.0) (p<0.001). We found a reduction in patients with ≥2 exacerbations (95% versus 17%; p<0.001), ≥1 emergency room visit (78% versus 37%; p<0.001) and ≥1 hospitalisation (47% versus 10%; p=0.001).Evaluation of uncontrolled asthma patients in a 1-day visit programme in a severe asthma centre resulted in significant improvements in asthma control, quality-of-life and healthcare use after 1 year. This 1-day visit approach seems beneficial for uncontrolled asthma patients and might reduce their dependence on expensive treatment modalities and long-term management in specialised centres.

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DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma

Respiratory Research ◽

10.1186/s12931-020-01541-7 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Andrew Menzies-Gow ◽

Sandhia Ponnarambil ◽

John Downie ◽

Karin Bowen ◽

Åsa Hellqvist ◽

...

Keyword(s):

High Dose ◽

Treatment Cessation ◽

Uncontrolled Asthma ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo ◽

Long Term Treatment ◽

To Receive

Abstract Background Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. The efficacy, safety and oral corticosteroid-sparing potential of tezepelumab are being investigated in two ongoing, phase 3, randomized, double-blind, placebo-controlled studies (NAVIGATOR [NCT03347279] and SOURCE [NCT03406078]). DESTINATION (NCT03706079) is a long-term extension (LTE) of these studies. Methods DESTINATION is a randomized, double-blind, placebo-controlled LTE study in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids. The study population will comprise patients who complete the 52- and 48-week NAVIGATOR and SOURCE studies, respectively. Patients who were randomized to receive tezepelumab 210 mg every 4 weeks (Q4W) in either predecessor study will continue to receive this regimen for 1 year; those who were previously randomized to receive placebo will be re-randomized (1:1) to receive either tezepelumab 210 mg Q4W or placebo for 1 year. Patients will receive their prescribed controller medications throughout DESTINATION and study physicians will have the opportunity to down- or up-titrate dosage of these medications, if appropriate. The primary objective is to evaluate the long-term safety and tolerability of tezepelumab over 104 weeks (inclusive of the treatment period of either predecessor study). The secondary objective is to assess the long-term effect of tezepelumab on asthma exacerbations. Patients recruited from SOURCE will be followed up post-treatment for 12 weeks. Patients recruited from NAVIGATOR who complete 100 weeks of tezepelumab treatment will be eligible for either 12 weeks of follow-up or a 36-week extended follow-up during which the clinical benefit of tezepelumab after treatment cessation will be investigated. Discussion DESTINATION will evaluate the long-term safety, tolerability and efficacy of tezepelumab versus placebo with continued dosing for up to 2 years. DESTINATION will also evaluate the clinical effect of tezepelumab after treatment cessation. This LTE study aims to elucidate the long-term safety implications of receiving tezepelumab and to assess its potential long-term treatment benefits in patients with severe, uncontrolled asthma. Trial registration NCT03706079 (ClinicalTrials.gov). Registered 15 October 2018.

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Clinical trial testing superiority of combination plinabulin (Plin) and pegfilgrastim (Peg) versus peg alone in breast cancer treated with high-risk febrile neutropenia risk chemotherapy (chemo): Final results of the phase 3 protective-2 in chemo-induced neutropenia (CIN) prevention.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.533 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 533-533

Author(s):

Douglas W. Blayney ◽

Yuankai Shi ◽

Hryhorii Adamchuk ◽

David Feng ◽

Qingyuan Zhang ◽

...

Keyword(s):

Clinical Trial ◽

High Risk ◽

Safety Profile ◽

Early Stage ◽

Standard Of Care ◽

Primary Objective ◽

Severe Neutropenia ◽

Double Blind Study ◽

Phase 3 ◽

Double Blind

533 Background: Peg is standard of care (SoC) for the prevention of CIN. Peg’s mechanism of action leaves patients vulnerable to FN in week 1 of the chemo cycle(C), as the absolute neutrophil count (ANC) does not normalize until week 2. Plin is a first-in-class, non-G-CSF small molecule agent, which received breakthrough designation from FDA in CIN. It prevents CIN by protecting progenitor cells in bone marrow from chemo assault and has normal ANC in week 1 (Blayney JAMA Onc 2020). Phase 2 testing showed the combination of Plin and Peg achieved CIN protection throughout the entire cycle vs Peg alone (Blayney: St Gallen 2019, ASCO 2019). Methods: Plin is given on Day (D)1 after Chemo, has a favorable safety profile, and also has anticancer activity. A separate phase 3 study evaluating Plin as an anticancer agent (DUBLIN-3; NCT02504489) in NSCLC pts is underway, with anti-cancer results in OS expected in 2021. In PROTECTIVE-2 (Study 106; NCT0329457), we added Plin (on D1) to Peg (on D2), testing superiority of the combination for CIN prevention vs Peg alone. Study 106, is a global multicenter randomized (1:1) double-blind study to evaluate Plin 40 mg + Peg 6mg (Arm 1) versus Peg 6mg + Placebo (Plac) (Arm 2) in preventing Severe Neutropenia (N), (defined as ANC <0.5 cells × 10E9/L) in early-stage BC (node positive or node negative with a high risk of recurrence) pts. 221 pts with ECOG status 0 or 1 received Docetaxel (75 mg/m2), Doxorubicin (50 mg/m2), and Cyclophosphamide (500 mg/m2) (TAC) on D1 for four 21 D cycles and study treatment. Central laboratory ANC was assessed at Covance in Cycle 1 (C1) on D 1, 2, 3, 6, 7, 8, 9, 10, 11, 12, 13, and 15. Primary objective was to compare the percentage (%) of pts with a Duration of Severe Neutropenia (DSN) of 0 days [that is % of pts with no Grade (Gr) 4 neutropenia (N)] in C1 in each arm. Key secondary endpoints were DSN and ANC Nadir in C1. We also evaluated safety (AE frequency and Grade). Conclusions: Adding Plin to Peg offers superior CIN protection compared to Peg alone and also has a superior safety profile by lowering over 20% of grade 4 AE. The effect size of the CIN protection in the combination is also correlated to clinical meaningful FN reduction compared to peg alone. Clinical trial information: NCT03531099. [Table: see text]

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Statistical analysis plan for the Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients with Acute Respiratory Failure trial

Critical Care and Resuscitation ◽

10.51893/2020.1.oa7 ◽

2020 ◽

Vol 22 (1) ◽

pp. 63-71

Author(s):

Rameela Chandrasekhar ◽

◽

Christopher G Hughes ◽

Brenda T Pun ◽

Onur M Orun ◽

...

Keyword(s):

Statistical Analysis ◽

Randomised Trial ◽

Randomised Clinical Trial ◽

Statistical Analysis Plan ◽

Brain Dysfunction ◽

Neurological Dysfunction ◽

Long Term Effects ◽

Double Blind ◽

Mechanically Ventilated

BACKGROUND: The best sedative medication to reduce delirium, mortality and long term brain dysfunction in mechanically ventilated septic patients is unclear. This multicentre, double-blind, randomised trial investigates the short term and long term effects of dexmedetomidine versus propofol for sedation in mechanically ventilated severely septic patients. OBJECTIVES: To describe the statistical analysis plan for this randomised clinical trial comprehensively and place it in the public domain before unblinding. METHODS: To ensure that analyses are not selectively reported, we developed a comprehensive statistical analysis plan before unblinding. This trial has an enrolment target of 420 severely septic and mechanically ventilated adult patients, randomly assigned to dexmedetomidine or propofol in a 1:1 ratio. Enrolment was completed in January 2019, and the study was estimated to be completed in September 2019. The primary endpoint is days alive without delirium or coma during first 14 study days. Secondary outcomes include 28-day ventilator-free days, 90-day all-cause mortality and cognitive function at 180 days. Time frames all begin on the day of randomisation. All analyses will be conducted on an intention-to-treat basis. CONCLUSION: This study will compare the effects of two sedatives in mechanically ventilated severely septic patients. In keeping with the guidance on statistical principles for clinical trials, we have developed a comprehensive statistical analysis plan by which we will adhere, as this will avoid bias and support transparency and reproducibility. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01739933).

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COMPARATIVE EVALUATION OF THE LONG-TERM EFFICACY AND SAFETY OF THE INFLIXIMAB BIOSIMILAR BCD-055 AND REFERENCE INFLIXIMAB IN PATIENTS WITH ANKYLOSING SPONDYLITIS: RESULTS OF THE INTERNATIONAL MULTICENTER RANDOMIZED DOUBLE-BLIND PHASE III CLINICAL STUDY ASART-2

Rheumatology Science and Practice ◽

10.14412/1995-4484-2018-293-301 ◽

2018 ◽

Vol 56 (3) ◽

pp. 293-301 ◽

Cited By ~ 1

Author(s):

A. M. Lila ◽

V. I. Mazurov ◽

E. V. Zonova ◽

O. B. Nesmeyanova ◽

T. V. Plaksina ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Safety Profile ◽

Neutralizing Antibodies ◽

Phase Iii ◽

Double Blind ◽

Reference Drug ◽

Patient Withdrawal ◽

Number Of Patients ◽

International Multicenter

The paper gives data on the clinical efficiency and safety profile of long-term use of the infliximab (INF) biosimilar BCD-055 versus the reference drug Remicade® (REM) in a population of patients with active ankylosing spondylitis (AS).Subjects and methods. An international multicenter randomized double-blind Phase III clinical trial was conducted in 199 patients who were randomized into two groups in a 2:1 ratio and who received BCD-055 or REM at a dose of 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Efficiency assessment was made at 14, 30 and 54 weeks in patients who received at least one dose of INF [intent-to-treat (ITT)], as well as at 54 weeks in those who completed the study according to the Protocol (PP) (per protocol). The efficiency endpoints were the proportion of patients who had achieved ASAS20/ASAS40 responses; changes in BASDAI, BASMI, BASFI, MASES, and SF-36 scores. Immunogenicity was assessed by the proportion of patients in each group with identified binding and neutralizing antibodies (BAbs and NAbs) against INF. The safety analysis included the overall rate of adverse events (AEs), including those that met the respective criteria for serous AEs (SAEs), and grade 3–4 toxicity, as well as the number of cases of early termination of the study because of AEs and SAEs.Results and discussion. The ITT population included 199 patients and the PP one consisted of 161 people. The groups were not statistically different in the rate of and reasons for patient withdrawal from the study. A comparable number of patients achieved ASAS20/ASAS40 responses at 14, 30, 54 weeks (р ≥ 0.05). At 54 week, the proportion of patients who received BCD-055 and REM therapy and achieved an ASAS20 response was 67.42 and 52.24% in the ITT population (p = 0.053) and 80.91 and 68.63% in the PP population (p = 0.128). The BCD-055 and drug comparison groups achieved an ASAS40 response in 53.03 and 38.81% in the ITT population (p = 0.081) and in 63.64 and 50.98% in the PP one (p = 0.177). The proportion of persons with identified BAbs and NAbs was comparable: 21.26 and 3.15% in the BCD-055 group (p = 0.920) and 20.63 and 6.35% in the group REM (p = 0.443), respectively. It was found that the presence of NAbs did not affect the therapeutic response. Both groups did not differ in the detection rate and profile of AEs and SAEs or in the rate of patient withdrawal due to AEs. Most identified AEs were mild to moderate.Conclusion. The efficacy of the INF biosimilar BCD-055 used long in patients with AS did not significantly differ from that of the original drug REM; the safety profile of both drugs was comparable.

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