scholarly journals EFFICACY AND SAFETY OF ADALIMUMAB IN ANKYLOSING SPONDYLITIS: DATA FROM REAL LIFE

2015 ◽  
Vol 24 (1) ◽  
pp. 44-49
Author(s):  
Claudiu Popescu ◽  
◽  
Cristina Coroama ◽  
Costin Mitulescu ◽  
Denisa Predeteanu ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Clinical Setting ◽  
Demyelinating Disease ◽  
Real Life ◽  
Time Frame ◽  
University Hospital ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Serious Adverse Events

Rationale. Data from controlled trials showed that adalimumab, a humanized anti-TNF monoclonal antibody, is effective and safe in the treatment of ankylosing spondylitis (AS). Objectives. The present study aimed to observe the effi cacy and safety of adalimumab in AS in a real life clinical setting. Methods. The study observed cross-sectionaly and retrospectively the efficacy and safety of adalimumab in all the patients admitted to the Rheumatology Department of “Sfânta Maria” Clinical Hospital between January 2008 and June 2013 who were classified as having AS according to the modified New York criteria. The diagnosis and follow-up of uveitic cases were done in the Ophthalmology Department of the Emergency University Hospital. Results. Within the study time-frame, 79 AS patients met the inclusion criteria: 71 (89.9%) had adalimumab for at least 24 months; 8 (10.1%) switched from adalimumab to another biological, as follows: 3 (3.8%) because of serious adverse events, 3 (3.8%) were primary non-responders and 2 (2.5%) were secondary non-responders. The clinical response was fast: after 3 months of treatment, 59 (83.1%) patients had BASDAI < 4 and 55 (77.5%) patients had BASFI < 4. Regarding safety, the serious adverse effects recorded were: infectious arthritis, pulmonary tuberculosis, pulmonary sarcoidosis. There were no cases of cancer or demyelinating disease during the study frame. Conclusions. Therapy with adalimumab in AS produces a prompt and lasting effect. The efficacy (remission) and safety (adverse events) of adalimumab can be monitored in the real-life clinical setting using BASDAI, BASFI, and routine clinical evaluations. Clinicians may need to expect a slightly higher rate of serious adverse events and rate of treatment discontinuation than those reported by controlled trials.

scholarly journals Controlled Trial of a 5-Day Course of Telithromycin versus Doxycycline for Treatment of Mild to Moderate Scrub Typhus

2007 ◽  
Vol 51 (6) ◽  
pp. 2011-2015 ◽  
Author(s):  
Dong-Min Kim ◽  
Ki Dong Yu ◽  
Ji Hyun Lee ◽  
Hyun Kuk Kim ◽  
Seung-Hyun Lee
Keyword(s):  
Adverse Events ◽  
Scrub Typhus ◽  
Controlled Trial ◽  
Sensitivity Study ◽  
University Hospital ◽  
Efficacy And Safety ◽  
Open Label ◽  
Serious Adverse Events ◽  
New Antibiotics

ABSTRACT New antibiotics are required to have the antibacterial activity against doxycycline-resistant Orientia tsutsugamushi. An in vitro sensitivity study showed that telithromycin was more effective than erythromycin for Rickettsia, Bartonella, and Coxiella burnetii. In this prospective, open-label, randomized trial, we enrolled patients with mild-to-moderate scrub typhus. We compared the efficacy and safety of a 5-day telithromycin therapy with those of a 5-day doxycycline therapy at Chosun University Hospital or one of its two community-based affiliated hospitals (Jangheung Hospital and Cheomdan Hospital), which are all located in southwestern Korea, between September and December 2005. A total of 92 patients were randomly assigned to either the telithromycin group (n = 47) or the doxycycline group (n = 45). After the treatment, fever control time was 20.45 ± 12.9 h in the telithromycin group and 22.60 ± 21.44 h in the doxycycline group (P > 0.05). After the treatment, the cure rate was 100% in the telithromycin group and 97.8% in the doxycycline group (P > 0.05). Furthermore, there were no significant differences in time elapsed until such symptoms as headache, myalgia, and rash disappeared. No serious adverse events or death were noted following the treatment in both groups. There were no significant differences in adverse events. In conclusion, the efficacy and safety of a 5-day once-a-day regimen of 800 mg telithromycin were equivalent to those of a 5-day twice-a-day regimen of 100 mg doxycycline in patients with mild-to-moderate scrub typhus. Telithromycin could be considered a promising new antibacterial agent for patients with scrub typhus.

scholarly journals Efficacy and safety of IL-17 inhibitors for the treatment of ankylosing spondylitis: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Yufeng Yin ◽  
Mingjun Wang ◽  
Mengru Liu ◽  
Erye Zhou ◽  
Tian Ren ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Response Rate ◽  
Phase Iii ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
End Point ◽  
Increased Risk ◽  
Severe Infections

Abstract Objectives: To systematically assess the efficacy and safety of IL-17 inhibitors in patients with active ankylosing spondylitis. Methods: A systematic review of the literature was performed for randomized controlled trials (RCTs) concerning IL-17 inhibitors in patients with ankylosing spondylitis. Meta-analyses were used to determine the efficacy and safety of the IL-17 inhibitors in the treatment of these patients. The primary end point was predefined as the proportion of patients with at least 20% improvement in the Assessment of Spondyloarthritis International Society (ASAS20) response criteria at week 16, and the secondary end point was defined as ASAS40 at week 16. Results: Six phase III randomized, double-blind, placebo-controlled trials including 1733 patients (1153 patients received IL-17 inhibitors, including secukinumab or ixekizumab, whereas 580 patients received a placebo as comparators) were included. At week 16, the IL-17 inhibitor regimen produced a significant increase in the ASAS20 response rate (RR=1.63, 95% CI 1.45 to 1.84, p=0.00) and the secondary endpoint ASAS40 response rate (RR=2.12, 95% CI 1.75 to 2.56, p=0.00) versus those for the placebo. With respect to the safety profile, more treatment-emergent adverse events (RR=1.11, 95% CI 1.01 to 1.22, p=0.03) and non-severe infections (RR=1.82, 95% CI 1.40 to 2.37, p<0.001) were described after treatment with IL-17 inhibitors than after treatment with placebo, while no increased risk of other adverse events was indicated after IL-17 inhibitor therapy, including death, discontinuation due to adverse events, or serious adverse events. Conclusions: IL-17 inhibitors produced favourable response rates but an increased risk of non-severe infections in the treatment of active ankylosing spondylitis.

scholarly journals Assessing the Short-Term Efficacy and Safety of Guselkumab for Moderate-to-Severe Plaque Psoriasis: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Jing Yang ◽  
Zongming Wang ◽  
Xilin Zhang
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Plaque Psoriasis ◽  
Sensitivity Analyses ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Severe Plaque Psoriasis ◽  
Randomized Controlled

Background. To investigate the efficacy and safety of guselkumab in the treatment of moderate-to-severe plaque psoriasis. Methods. A systematic review was undertaken to identify double-blind randomized controlled trials (RCTs). PubMed, Web of Science, Cochrane Library, EMBASE, and Google Scholar databases were searched before 1 March 2020. The odds ratios (ORs) with 95% confidence interval (CI) were calculated. All analyses were conducted with intention-to-treat basis. A range of sensitivity analyses was undertaken. Results. A total of 7 articles contained 1206 plaque psoriasis patients with guselkumab, 585 patients with placebo, and 1250 patients with adalimumab were included. The results indicated that guselkumab had better efficacy than placebo or adalimumab for Psoriasis Area and Severity Index score reductions from baseline of 75% (PASI 75) (OR=61.37, 95% CI=31.15 to 120.91; OR=3.08, 95% CI=2.35 to 4.06), Investigator’s Global Assessment scores of 0 or 1 (IGA 0/1) (OR=65.75, 95% CI=45.54 to 94.95; OR=2.79, 95% CI=2.17 to 3.59), and Dermatology Life Quality Index scores of 0 or 1 (DLQI 0/1) (OR=29.64, 95% CI=18.80 to 46.73; OR=1.86, 95% CI=1.50 to 2.31). The guselkumab had similar safety with placebo or adalimumab about the incidence of adverse events (AEs) (OR=1.05, 95% CI=0.86 to 1.29; OR=0.97, 95% CI=0.79 to 1.19) and serious adverse events (SAEs) (OR=1.03, 95% CI=0.47 to 2.27; OR=0.91, 95% CI=0.44 to 1.87). Meanwhile, there was no statistically significant association of infections and serious infections compared with the placebo or adalimumab group. The guselkumab was more effective and had the similar tolerance. Conclusion. The guselkumab had excellent efficacy and great safety in moderate-to-severe plaque psoriasis, but long-term safety remained to be determined.

scholarly journals Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

2013 ◽  
Vol 29 (suppl 1) ◽  
pp. s17-s31 ◽  
Author(s):  
Cassyano Januário Correr ◽  
Inajara Rotta ◽  
Thaís de Souza Teles ◽  
Rangel Ray Godoy ◽  
Bruno Salgado Riveros ◽  
...  
Keyword(s):  
Adverse Events ◽  
Meta Analysis ◽  
Biological Agents ◽  
Severe Psoriasis ◽  
Biological Agent ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Short Term ◽  
Serious Adverse Events

We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible.

Efficacy and safety of IL-17 inhibitors for the treatment of ankylosing spondylitis: a meta-analysis of randomized controlled trials

2020 ◽  
Author(s):  
Yufeng Yin ◽  
Mingjun Wang ◽  
Mengru Liu ◽  
Erye Zhou ◽  
Tian Ren ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Infectious Diseases ◽  
Randomized Controlled Trials ◽  
Response Rate ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
End Point ◽  
Increased Risk

Abstract Objectives: To systematically assess the efficacy and safety of IL-17 inhibitors in patients with active ankylosing spondylitis.Methods: Electronic databases were searched for randomized controlled trials (RCTs) concerning IL-17 inhibitors in patients with ankylosing spondylitis. The efficacy and safety of the IL-17 inhibitors in the treatment of these patients were compared to those of a placebo. The primary end point was predefined as the proportion of patients with at least 20% improvement in the Assessment of Spondyloarthritis International Society (ASAS20) response criteria at week 16, and the secondary end point was defined as ASAS40 at week 16.Results: Six phase III randomized, double-blind, placebo-controlled trials including 1733 patients (1153 patients received IL-17 inhibitors, including secukinumab or ixekizumab, whereas 580 patients received a placebo as comparators) were included. At week 16, the IL-17 inhibitor regimen produced a significant increase in the ASAS20 response rate (RR=1.63, 95% CI 1.45 to 1.84, p=0.00) and the secondary endpoint ASAS40 response rate (RR=2.12, 95% CI 1.75 to 2.56, p=0.00) versus those for the placebo. With respect to the safety profile, more infectious diseases were described after treatment with IL-17 inhibitors than after treatment with placebo (RR=1.82, 95% CI 1.40 to 2.37, p<0.001), while no increased risk of other adverse events was indicated after IL-17 inhibitor therapy, including treatment-emergent adverse events, death, discontinuation due to adverse event, serious adverse events, or total adverse events.Conclusions: IL-17 inhibitors produced favourable response rates but an increased risk of infectious diseases in the treatment of active ankylosing spondylitis.

scholarly journals Efficacy and safety of jakinibs in rheumatoid arthritis: A systematic review and meta-analysis

2020 ◽  
Author(s):  
Yufeng Yin ◽  
Mengru Liu ◽  
Xin Chang ◽  
Michun He ◽  
Mingjun Wang ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Clinical Response ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Increased Risk ◽  
Serious Infections

Abstract Objectives To assess the efficacy and safety of jakinibs for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). Methods A systematic search was conducted in PubMed, Embase and the Cochrane Library. Randomized placebo-controlled trials (RCTs) of jakinibs in RA patients were eligible. The effective outcome was RA improvement to reach an American College of Rheumatology 20%/50%/70% (ACR20/50/70) response rate at week 12 and 24 after treatment. The safety outcomes included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), discontinuations due to adverse events, infections and serious infections. Results Twenty-eight randomized, double-blind, controlled trials including 14500 patients were included. Both at week 12 and 24, the pooled analysis was suggestive of an effective treatment with jakinibs, represented as the increased clinical response of ACR20, ACR50 and ACR70. The subgroup analysis based on different types of jakinibs demonstrated that only peficitinib treatment had no impact on the clinical response of ACR50 or ACR70 at week 12. Jakinibs were associated with an increased incidence of infections at week 12 and TEAEs and infections at week 24. No increase in the risk of SAEs, discontinuations due to adverse events, or serious infections was observed in comparisons between treatment with jakinibs and treatment with placebo in these patients. Conclusions Jakinibs are efficacious and well tolerated in RA patients up to a period of 24 weeks, although they are associated with an increased risk of infectious complications.

scholarly journals Efficacy and safety of canakinumab for colchicine-resistant or colchicine-intolerant familial Mediterranean fever: A single-centre observational study

2021 ◽  
Author(s):  
Takuya Tomokawa ◽  
Tomohiro Koga ◽  
Yushiro Endo ◽  
Toru Michitsuji ◽  
Atsushi Kawakami
Keyword(s):  
Familial Mediterranean Fever ◽  
Adverse Events ◽  
Real World ◽  
Clinical Setting ◽  
Japanese Patients ◽  
Efficacy And Safety ◽  
Attack Frequency ◽  
Serious Adverse Events ◽  
Targeted Next Generation Sequencing ◽  
Mediterranean Fever

ABSTRACT Objectives To evaluate the efficacy and safety of canakinumab in Japanese patients with colchicine-resistant or colchicine-intolerant familial Mediterranean fever (FMF) in a real-world clinical setting. Methods We reviewed 13 Japanese FMF patients to whom canakinumab was introduced during the period of October 2017 to December 2020. All patients were diagnosed as FMF according to Tel-Hashomer criteria. We performed genetic analyses for Mediterranean fever or MEFV by targeted next-generation sequencing. Efficacy was assessed by attack frequency and the percentage of patients who achieved attack improvement at 24 weeks. Safety was assessed by adverse events observed during canakinumab treatment. Results The median duration and follow-up of canakinumab treatment were 13 and 16 months, respectively. The median attack frequency was 0.50 [0.30–1.00] at 24 weeks, which was a significant decrease from 2.00 [0.85–2.88] at the time of induction (p = .019). There were three patients (23%) with complete resolution of attacks at 24 weeks. No serious adverse events were observed. However, one patient had small intestinal ulceration which led to the discontinuation of canakinumab. Conclusions Although the number of cases is small, this study suggests that canakinumab is efficacious and safe for use in Japanese patients with colchicine-resistant or colchicine-intolerant FMF in a real-world clinical setting in Japan.

Longitudinal Study of Sustained-Release Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema

2016 ◽  
Vol 235 (4) ◽  
pp. 187-188 ◽  
Author(s):  
Isabelle Aknin ◽  
Laurent Melki
Keyword(s):  
Adverse Events ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real Life ◽  
Injection Rate ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Dexamethasone Intravitreal Implant ◽  
Anti Vegf ◽  
Intravitreal Implant

Observational studies are needed to confirm the long-term efficacy and safety of Ozurdex® intravitreal implant in real life. Among 29 patients with persistent diabetic macular edema (DME), of whom 14 (48%) patients did not have any previous treatments and 22 (76%) any previous antivascular endothelial growth factor (anti-VEGF) injections, significant visual acuity (VA) improvement was observed with a mean gain of 13.8 letters at month 6 (p < 0.0001), 12.7 letters at month 12 (p = 0.0032) and 16.5 letters at month 18 (p = 0.0313). During the follow-up, a total of 17 (59%) patients had a VA improvement of ≥15 letters. Significant central macular thickness decrease was observed with a mean reduction of 159.07 μm at month 6 (p < 0.0001), 181.8 μm at month 12 (p < 0.0001) and 236.17 μm at month 18 (p = 0.0313). No serious adverse events were reported. With a good efficacy and safety, manageable adverse events and an injection rate much lower compared to that of anti-VEGF, this study confirms the use of Ozurdex® for the treatment of persistent DME.

P706Treatment of hypercholesterolaemia with PCSK-9 Inhibitors in Denmark. Assessment of real-life data; safety an extent of adverse effects after the first years of clinical use

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Mulverstedt ◽  
I C Klausen ◽  
M H Martinsen ◽  
H Kanstrup ◽  
K K Thomsen ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Adverse Events ◽  
Plasma Lipids ◽  
Real Life ◽  
Outcome Studies ◽  
Control Group ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Wide Range ◽  
Significant Difference

Abstract Introduction PCSK9 Inhibitors (PCSK9 I) are a new group of drugs for treatment of hyperlipidaemia. These drugs have been available in Denmark since October 2015. From the two existing major outcome studies (FOURIER and ODYSSEY OUTCOMES) it has been shown that there was no significant difference in the risk of serious adverse events, discontinuation due to adverse events, neurocognitive events, diabetes-related events, muscle-related events, or myalgia in the treatment group, compared with the control group. In FOUIRER 12.5% came of treatment; In ODYSSEY the rate was 10.2–14.8%. Although this highlights the efficacy and safety in patients with cardiovascular disease, we have little knowledge of the use, efficacy and safety with these drugs in real-life populations Purpose We aim to describe the demography, the treatment efficacy and the extent of adverse effects among patients treated in Danish lipid clinics. Methods Data on all patients treated with PCSK9 I between October 1st, 2015 and May 1st, 2018 were obtained from lipid clinics in Denmark. A database containing information on medications before treatment, adverse effects, plasma lipids (LDL-C, Triglyceride, High density lipoprotein cholesterol (HDL-C)) and supplementary blood tests was created. Levels of plasma lipids and organ markers (Creatinine, Hba1c or Alanine aminotransferase (ALAT)) at baseline and at follow up visits were analysed. Results Nationwide, 383 patients were included, an estimated 90% of all patients undergoing treatment with PCSK9 I in Denmark. A large proportion (n=243 - 63.4%) were described as statin intolerant and only 94 patients were receiving statins at baseline. Adverse effects (AE) were reported by 71 patients (18.5%) on PCSK9 I therapy and 50 patients (13.1%) stopped treatment. Most common AE were flu like symptoms and musculoskeletal aches. In two cases an increase in serum creatinine kinase was detected. One case of angioedema and three cases of local reactions to injections had been documented. No case of anaphylaxis was reported. Of the 71 patients with AEs 55 (77.5%) were statin intolerant. Of the 50, who came off treatment, 43 (86.0%) were statin intolerant. When treatment was stopped 15 patients (30.0%) tried the alternative PCSK9 Inhibitor (cross over). Of those, nine patients were able to tolerate the alternative PCSK9 I treatment. Conclusion Many patients (18.3%) reported AEs on a wide range of symptoms, but the rate of patients terminating PCSK9 I treatment was the same as found in the outcome studies (13.1% vs. 12.2 and 10.2–14.8%). Most of the patients who stopped treatment were statin intolerant and produced the same symptoms, as they had experienced with statins. Interestingly, nine of the 15 patients that were switched to the alternate PCSK9 I seems to tolerate this treatment.

Safety of Efalizumab in Patients with Moderate to Severe Chronic Plaque Psoriasis: Review of Clinical Data. Part II

2005 ◽  
Vol 9 (6) ◽  
pp. 313-323 ◽  
Author(s):  
Kim A. Papp ◽  
Charles Camisa ◽  
Stephen P. Stone ◽  
Ivor Caro ◽  
Xiaolin Wang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Safety Profile ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Chronic Plaque Psoriasis ◽  
Serious Adverse Events ◽  
The Third ◽  
Increased Risk ◽  
Favorable Safety

Background: The efficacy and safety of efalizumab have been evaluated in multiple clinical trials. ObjectiveThe purpose of this review is to provide an overview of the safety profile of efalizumab during the clinical trials. Methods: Twelve-week data from four placebo-controlled trials were pooled and analyzed. Data from patients receiving 13—60 weeks of efalizumab therapy were pooled to evaluate longer-term safety. Results: The most common adverse events were mild to moderate, self-limiting, flulike symptoms that were most frequent following the first two efalizumab doses; by the third dose the incidence was comparable to placebo. Serious adverse events were observed in 2.2% and 1.7% of efalizumab- and placebo-treated patients, respectively. Nonserious adverse events leading to withdrawal were infrequent and similar to placebo (2.8% vs 1.8%). There does not appear to be increased risk of end-organ toxicity, infection, or malignancy in efalizumab-treated patients. Conclusion: Efalizumab was well tolerated, with a favorable safety profile.

Sign in / Sign up

Export Citation Format

Share Document