scholarly journals Secukinumab and Sustained Improvement in Signs and Symptoms of Patients With Active Ankylosing Spondylitis Through Two Years: Results From a Phase III Study

2017 ◽  
Vol 69 (7) ◽  
pp. 1020-1029 ◽  
Author(s):  
H. Marzo-Ortega ◽  
J. Sieper ◽  
A. Kivitz ◽  
R. Blanco ◽  
M. Cohen ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Signs And Symptoms ◽  
Phase Iii ◽  
Sustained Improvement ◽  
Phase Iii Study

scholarly journals Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study

2016 ◽  
Vol 76 (6) ◽  
pp. 1070-1077 ◽  
Author(s):  
Jürgen Braun ◽  
Xenofon Baraliakos ◽  
Atul Deodhar ◽  
Dominique Baeten ◽  
Joachim Sieper ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Response Rates ◽  
Phase Iii ◽  
X Rays ◽  
Serious Adverse Events ◽  
Radiographic Outcomes ◽  
Clinical Signs And Symptoms ◽  
Radiographic Changes

ObjectiveTo evaluate the effect of secukinumab, an interleukin-17A inhibitor, on clinical signs and symptoms and radiographic changes through 2 years in patients with ankylosing spondylitis (AS).MethodsIn the phase III MEASURE 1 study, patients were randomised to receive intravenous secukinumab 10 mg/kg (at baseline, week 2 and week 4) followed by subcutaneous secukinumab 150 mg (intravenous 150 mg; n=125) or 75 mg (intravenous 75 mg; n=124) every four weeks, or matched placebo (n=122). Placebo-treated patients were re-randomised to subcutaneous secukinumab 150 or 75 mg from week 16. Clinical efficacy assessments included Assessment of SpondyloArthritis international Society 20 (ASAS20) response rates through week 104. Radiographic changes at week 104 were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS).Results97 (77.6%) and 103 (83.1%) patients in the intravenous 150 mg and intravenous 75 mg groups, respectively, completed week 104. In the full analysis set (intent-to-treat), ASAS20 response rates at week 104 were 73.7% and 68.0% in the intravenous 150 mg and intravenous 75 mg groups, respectively. Among patients with evaluable X-rays who were originally randomised to secukinumab (n=168), mean change in mSASSS from baseline to week 104 was 0.30±2.53. Serious adverse events were reported in 12.2% and 13.4% of patients in the 150 mg and 75 mg groups, respectively.ConclusionsSecukinumab improved AS signs and symptoms through 2 years of therapy, with no unexpected safety findings. Data from this study suggest a low mean progression of spinal radiographic changes, which will need to be confirmed in longer-term controlled studies.Trial registration numberNCT01358175.

scholarly journals Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001457
Author(s):  
Christopher T Ritchlin ◽  
Philip S Helliwell ◽  
Wolf-Henning Boehncke ◽  
Enrique R Soriano ◽  
Elizabeth C Hsia ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Treated Patient ◽  
Human Monoclonal Antibody ◽  
Clinical Manifestations ◽  
Study Participant ◽  
Signs And Symptoms ◽  
Phase Iii ◽  
Sustained Improvement ◽  
Randomised Study ◽  
Tnfα Inhibitor

ObjectiveEvaluation of the efficacy and safety of guselkumab, a human monoclonal antibody targeting the interleukin-23p19 subunit, in patients with psoriatic arthritis (PsA) through 1 year.MethodsAdults who met ClASsification criteria for Psoriatic ARthritis, with active disease (≥3 swollen and ≥3 tender joints; C reactive protein ≥0.3 mg/dL) despite standard treatment (31% previously received ≤2 tumour necrosis factor inhibitors (TNFi)), were randomised (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week0, Week4, then Q8W; or placebo with cross-over to guselkumab 100 mg Q4W at Week24 (PBO→Q4W) through Week48. Clinical efficacy through Week52 (employing non-responder imputation) and adverse events (AEs) through Week60 were evaluated.ResultsOf 381 treated patients, 90% completed the study. Numerical increases in the proportions of patients achieving ≥20% improvement in ACR criteria (ACR20) were observed post-Week24, reaching 73% (94/128) and 60% (76/127) for Q4W-randomised and Q8W-randomised patients, respectively, by Week52. Proportions of patients achieving ACR50/ACR70/skin responses and minimal/very low disease activity were maintained, as were improvements in physical function and health-related quality of life, through Week52 in guselkumab-randomised patients. Response to guselkumab was maintained in both TNFi-naïve and TNFi-experienced patients. Serious AEs and serious infections occurred in similar proportions of guselkumab Q4W-randomised (3% and 0%) and Q8W-randomised (6% and 2%) patients through Week60, with no new safety concerns versus observations through Week24. No guselkumab-treated patient and two patients receiving placebo died; no study participant developed opportunistic infection or inflammatory bowel disease.ConclusionGuselkumab provided sustained improvement across multiple clinical manifestations of PsA, maintaining a favourable benefit-risk profile, through 1 year regardless of prior TNFi exposure.

Pasireotide treatment significantly improves clinical signs and symptoms in patients with Cushing's disease: results from a Phase III study

2014 ◽  
Vol 81 (3) ◽  
pp. 408-417 ◽  
Author(s):  
Rosario Pivonello ◽  
Stephan Petersenn ◽  
John Newell-Price ◽  
James W. Findling ◽  
Feng Gu ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Phase Iii Study ◽  
Clinical Signs And Symptoms

scholarly journals Safety and Efficacy of Golimumab Administered Intravenously in Adults with Ankylosing Spondylitis: Results through Week 28 of the GO-ALIVE Study

2017 ◽  
Vol 45 (3) ◽  
pp. 341-348 ◽  
Author(s):  
Atul Deodhar ◽  
John D. Reveille ◽  
Diane D. Harrison ◽  
Lilianne Kim ◽  
Kim Hung Lo ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Activity Index ◽  
Controlled Trial ◽  
Disease Activity Index ◽  
Signs And Symptoms ◽  
Phase Iii ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Link Type ◽  
Secondary Endpoints

Objective.To evaluate the safety and efficacy of intravenous golimumab (GOL) in patients with active ankylosing spondylitis (AS).Methods.In a phase III, randomized, double-blind, placebo (PBO)-controlled trial, 208 patients were randomized (1:1) to intravenous (IV) infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, 12, and every 8 weeks, or PBO (n = 103) at weeks 0, 4, and 12, with crossover to GOL at Week 16. The primary endpoint was ≥ 20% improvement from baseline in the Assessment of Spondyloarthritis International Society Criteria (ASAS20) at Week 16. Secondary endpoints included ASAS40, ≥ 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50), and change in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16. Safety was monitored through Week 28.Results.Significantly greater proportions of GOL-treated patients had ASAS20 response at Week 2 (37.1% vs 19.4%; p = 0.005) and at Week 16 (73.3% vs 26.2%; p < 0.001). At Week 16, 41.0% of those receiving GOL achieved BASDAI50 compared with 14.6% of those taking PBO (p < 0.001), and the GOL group had greater mean improvement in BASFI (−2.4 vs −0.5; p < 0.001). Through Week 16, 23.3% of patients in the PBO group and 32.4% of patients in the GOL group had ≥ 1 adverse event (AE); infections being the commonest type of AE. Through Week 28, two GOL-treated patients had a serious AE.Conclusion.GOL 2 mg/kg administered IV at weeks 0, 4, and every 8 weeks significantly reduced the signs and symptoms of AS in adults. AE were consistent with other antitumor necrosis factor therapies, with no new safety signals (Clinicaltrials.gov: NCT02186873).

Golimumab: A User's Guide to a New Biologic Treatment

2010 ◽  
Vol 16a (2) ◽  
pp. 51-56
Author(s):  
Melissa A. Michelon ◽  
Andrew Wang
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Health Care Providers ◽  
Signs And Symptoms ◽  
Severity Index ◽  
Phase Iii ◽  
Care Providers ◽  
Effective Treatment Option ◽  
Biologic Treatment ◽  
Medline Search

Background Golimumab is a new tumor necrosis factor (TNF) antagonist recently approved by the Food and Drug Administration for controlling the signs and symptoms of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, although it is not currently approved for use in psoriasis. Objective To give readers a review of current literature and clinical trials of golimumab and serve as a guide to this new biologic therapy. Methods A Medline search was performed using the following terms: golimumab, anti-TNF, psoriasis, and psoriatic arthritis. Product inserts were obtained from fda.gov/Drugs. Results In a phase III clinical trial comprising patients with psoriatic arthritis, patients receiving golimumab showed significant improvement in the signs and symptoms of disease. Significant changes in the Psoriasis Area and Severity Index were also observed in patients with at least 3% body surface area treated with golimumab. Other assessments included the Nail Psoriasis Severity Index, Physician's Global Assessment of psoriatic nail disease, and the psoriatic arthritis modified Maastricht Ankylosing Spondylitis Enthesitis Score, all of which showed notable improvement in golimumab-treated patients compared with placebo. Golimumab was usually well tolerated in phase III trials, but adverse events generally occurred more often in patients receiving golimumab compared with placebo. Long-term safety studies are ongoing. Conclusion Golimumab, one of the newest anti-TNF therapies, offers health care providers another effective treatment option for patients with psoriatic arthritis with a similar side effect profile and convenient dosing schedule relative to other available TNF antagonists.

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