scholarly journals Efficacy and Tolerance of 5-Aminosalicylic Acid Suppositories in the Treatment of Ulcerative Proctitis: A Review of Two Double-Blind, Placebo Controlled Trials

1990 ◽  
Vol 4 (7) ◽  
pp. 472-475 ◽  
Author(s):  
CN Williams
Keyword(s):  
Placebo Group ◽  
Disease Activity ◽  
Global Assessment ◽  
Activity Index ◽  
Disease Activity Index ◽  
Aminosalicylic Acid ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Ulcerative Proctitis ◽  
Significant Difference

The efficacy and tolerance of 500 mg 5-aminosalicylic acid (mesalamine) suppositories in the treatment of ulcerative proctitis were assessed in two double-blind, placebo controlled studies of six weeks' duration, involving a total of 173 patients. In trial 1, patients used one 500 mg suppository tid. In trial 2, patients used one 500 mg suppository bid. Physician's global assessment and a disease activity index based upon patient symptoms and sigmoidoscopic appearance were used to assess efficacy. At the endpoint of trial l (tid), there was an 80.4% mean reduction in the disease activity index seen in patients treated with mesalamine compared to a 36.8% mean reduction in the placebo group (P<0.05). Analysis of the physician's global assessment indicated that 84.2% of patients receiving mesalamine were considered to be 'much improved' compared to 41 % of patients on placebo (P<0.01). At the endpoint of trial 2 (tid), there was a 74.7% mean reduction in disease activity index compared to 34.2% in the placebo group (P<0.001). Analysis of the physician's global assessment indicated that 79.2% of the mesalamine group was considered to be 'much improved' compared to 26.2% on placebo (P<0.001). There was no significant difference in efficacy seen in patients treated with 500 mg mesalamine suppositories bid or tid. Mesalamine suppositories are effective and well tolerated in the treatment of ulcerative proctitis.

scholarly journals A Double-Blind, Placebo Controlled, Multicentre Study of the Efficacy And Safety of 5-Aminosalicylic Acid Tablets in the Treatment of Ulcerative Colitis

1990 ◽  
Vol 4 (7) ◽  
pp. 463-467 ◽  
Author(s):  
LR Sutherland ◽  
M Robinson ◽  
G Onstad ◽  
M Peppercorn ◽  
N Greenberger ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Global Assessment ◽  
Activity Index ◽  
Disease Activity Index ◽  
Controlled Study ◽  
Active Ulcerative Colitis ◽  
Aminosalicylic Acid ◽  
Double Blind ◽  
Double Blind Placebo

This double-blind, placebo controlled, multicentre, parallel trial assessed the efficacy of two oral doses of a new formulation of 5-aminosalicylic acid (5-ASA) targeted to release in the cecum which was given for six weeks to 136 patients with active ulcerative colitis. Seven centres participated (two Canadian, five American). Patients were randomly assigned to one of three treatment groups (4 g 5-ASA, 2 g 5-ASA or placebo). Medication was dispensed as 250 mg identically appearing tablets containing either 5-ASA or placebo to be taken four times a day. Subjects were assessed at baseline and after three and six weeks of treatment. Assessments included a disease activity index, physician's global assessment and flexible sigmoidoscopy. Compliance was assessed through pill count. A total of 136 patients participated ( 4 7 on 4 g 5-ASA, 45 on 2 g 5-ASA, and 44 on placebo). The three groups were similar in terms of age, weight, distribution of disease, extent of disease, and previous use of steroids or sulphasalazine. Ninety patients completed the six week study. Of the 46 dropouts, 38 (82.6%) left because of insufficient efficacy ( most on either place ho or 2 g 5-ASA), four (8.7%) had adverse reactions (all on 5-ASA), the remaining four (8.7%) left for reasons not related to their ulcerative colitis. The disease activity index represents a composite score ( maximum of 12) with categories for number of daily stools, presence of bleeding, abdominal pain and physician's assessment of disease activity. Patients who received 4 g 5-ASA daily demonstrated significant declines in disease activity index within three weeks of therapy and maintained improvement until the end of the stuuy. Although disease activity index declined for patients receiving 2 g 5-ASA daily, these changes did not reach statistical significance when compared to placebo-treated patients. On a five point scale (much improved, somewhat improved, unchanged, somewhat worse, much worse) the physician's global assessment mirrored the changes in disease activity index. Patients randomized to receive 4 g 5-ASA tablets were consistently noted as being either much or somewhat improved compared to placebo-treated patients. Side effects were few and minor and 52% (4 g 5-ASA), 42% (2 g 5-ASA) and 37% (placebo) of patients had no complaints. Headache was the most commonly cited adverse reaction for 6.9% (4 g 5-ASA) and 9.4% (2 g 5-ASA) of treated patients but 3.5% of placebo-treated patients also complained of headache. In conclusion in this randomized double-blind, placebo controlled study, patients with active ulcerative colitis randomized to 4 g 5-ASA per day noted improvement in disease activity as measured by disease activity index and physician's global assessment when compared to placebo-treated patients. ln contrast, patients who received 2 g 5-ASA daily did not demonstrate significant differences compared to the placebo group.

scholarly journals AB0100 EVALUATION OF PGA LEVEL FOR CLINICAL REMISSION WITH BOOLEAN CRITERIA, 10MM OR 20MM?

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1078.1-1079
Author(s):  
I. Yoshii
Keyword(s):  
Disease Activity ◽  
Patient Group ◽  
Clinical Remission ◽  
Global Assessment ◽  
Activity Index ◽  
T Test ◽  
Mean Values ◽  
Significant Difference ◽  
Remission Criteria ◽  
The Mean

Background:Patient’s global assessment (PGA) is one important component of Boolean composite criteria for remission in treat with rheumatoid arthritis (RA). However, PGA no more than 10mm is sometimes obstacle to attain clinical remission. In recent few years, one opinion that PGA no more than 20mm may be comparable as no more than 10mm.Objectives:The aim of this study is to analyze how difference of these PGA level affect disease activity and daily activities in living, and evaluate which is optimal for the remission with Boolean remission criteria from real world setting.Methods:RA patients who were followed up for more than three years in the institute were picked up in the study. Each patient was monitored with tenderness joint count (TJC), swollen joint count (SJC), PGA, evaluator’s global assessment (EGA), serum C-reactive protein level (CRP), calculated disease activity score with simplified disease activity index(SDAI), Health Assessment Questionnaire Disability Index (HAQ-DI), and pain score using visual analog scale (PS-VAS) every consulted time from the first encounter (Baseline). Patients were classified according to achievement of Boolean remission criteria. Group 1: a patient group who attained Boolean remission wih TJC≦1, SJC≦1, CRP≦1mg/dl, and PGA≦1 (G-1), Group 2: a patient group who could not attained the Boolean remission used in the G-1 evaluation, but could attained another Boolean remission with TJC≦1, SJC≦1, CRP≦1mg/dl, and PGA≦2 (G-2), and Group 3: a patient group who could not attain Boolean remission for neither criterion.Mean values of measured parameters at Baseline and after the Baseline were compared statistically with Student T-test. Mean values of the same parameters in the G-1 and G-2 at the time of attain Boolean remission for each criteria, mean values of each of these parameters thereafter, and changes of these parameters were compared statistically with Student T-test.Results:A total of 438 patients 385 in the G-1 group, 16 in the G-2 group, and 37 in the G-3 group, were recruited. In parameters at Baseline, level of TJC, SJC, PGA, EGA, SDAI, and HAQ-DI in the G-1 was significantly lower than in the G-3, whereas no significant differences in any parameters demonstrated between in the G-2 and G-3. Level of HAQ-DI, and PS-VAS after Baseline in the G-1 was lower than in the G-3, whereas no significant difference of these parameters after Baseline demonstrated between in the G-2 and G-3. TJC, SJC, PGA, and EGA demonstrated significant less level in the G-1 than in the other two groups. The mean SDAI score at the time of first achievement of Boolean remission in the G-1 and G-2 were 1.08 and 2.57, respectively. The mean value of SDAI score after remission in the G-1 and G-2 were 3.35 and 6.44, respectively. These values and PS-VAS including change of the SDAI score demonstrated significant difference between the two groups (p<0.01), whereas HAQ-DI in the two groups demonstrated no significant difference.Conclusion:These results suggested that setting PGA as no more than 10mm should be reasonable for the evaluation of clinical remission with the Boolean criteria.Disclosure of Interests:None declared

scholarly journals Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study

2021 ◽  
pp. annrheumdis-2021-219876
Author(s):  
Evgeniy Nasonov ◽  
Saeed Fatenejad ◽  
Eugen Feist ◽  
Mariana Ivanova ◽  
Elena Korneva ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Phase Iii ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Acr20 Response

ObjectiveTo evaluate the efficacy and safety of olokizumab (OKZ) in patients with active rheumatoid arthritis despite treatment with methotrexate (MTX).MethodsIn this 24-week multicentre, placebo-controlled, double-blind study, patients were randomised 1:1:1 to receive subcutaneously administered OKZ 64 mg once every 2 weeks, OKZ 64 mg once every 4 weeks, or placebo plus MTX. The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at week 12. The secondary efficacy endpoints included percentage of subjects achieving Disease Activity Score 28-joint count based on C reactive protein <3.2, Health Assessment Questionnaire Disability Index at week 12, ACR50 response and Clinical Disease Activity Index ≤2.8 at week 24. Safety and immunogenicity were assessed throughout the study.ResultsA total of 428 patients were randomised. ACR20 responses were more frequent with OKZ every 2 weeks (63.6%) and OKZ every 4 weeks (70.4%) than placebo (25.9%) (p<0.0001 for both comparisons). There were significant differences in all secondary efficacy endpoints between OKZ-treated arms and placebo. Treatment-emergent serious adverse events (TESAEs) were reported by more patients in the OKZ groups compared with placebo. Infections were the most common TESAEs. No subjects developed neutralising antidrug antibodies.ConclusionsTreatment with OKZ was associated with significant improvement in signs, symptoms and physical function of rheumatoid arthritis without discernible differences between the two regimens. Safety was as expected for this class of agents. Low immunogenicity was observed.Trial registration numberNCT02760368.

scholarly journals AB0669 PARTICULARITIES OF TUNISIAN FEMALE AXIAL SPONDYLOARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1629.2-1629
Author(s):  
K. Ben Abdelghani ◽  
Y. Gzam ◽  
A. Fazaa ◽  
S. Miladi ◽  
K. Ouenniche ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Age At Onset ◽  
Disease Onset ◽  
Disease Activity Index ◽  
Reactive Protein ◽  
Significant Difference ◽  
The Mean

Background:Axial spondyloarthritis (ax-SpA) is a chronic rheumatic disease that mainly affects men. However, the female form of ax-SpA remains insufficiently studied.Objectives:The aim of this study was to determine the clinical characteristics, the disease activity and the functional impact of female ax-SpA in comparison with male ax-SpA.Methods:This is a retrospective study including patients diagnosed with ax-SpA fulfilling the criteria of the Assessment of SpondyloArthritis international Society (ASAS) 2009.Clinical parameters, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath ankylosing spondylitis disease activity index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) were compared between groups of female and male ax-SpA.Results:Two hundred ax-SpA patients were included with 31% of female (n=62) and a mean age of 43,3 ± 11,2 years.The mean age at onset of symptoms was 31,8 ± 8,9 years for women and 25,3 ± 9,1 years for men (p <0,0001). The mean age at diagnosis was 36,4 ± 9,6 years for women and 31,7 ± 10,4 years for men (p = 0,003). Ax-SpA with juvenile onset was noted in 1,7% of women and 12,1% of men (p = 0,02). Male ax-SpA were significantly more smokers (46.8% vs 5.4%; p <0.001). The mean duration of morning stiffness was 11,3 ± 9,2 minutes for women versus 21,6 ± 19,3 minutes for men (p = 0,005).The mean ESR was 42,4 ± 29,8 mm for women and 28,3 ± 23,4 mm for men (p = 0,001). Radiographic sacroiliitis was present in 69,3% of women versus 84,7% of men (p = 0,01). The use of anti-TNF alpha was less frequent in women (29% vs 48,5%; p = 0,01).Our study didn’t found a statistically significant difference in peripheral manifestations, extraarticular manifestations, CRP, BASDAI and BASFI between the two groups.Conclusion:Female ax-SpA seems to have a better prognosis than male with older age in disease onset, less inflammation, less radiographic sacroiliitis and less use of biological treatments.References:[1]Rusman T, et al. Curr Rheumatol Rep. 2018; 20(6).[2]Siar N, et al. Curr Rheumatol Rev. 2019;Disclosure of Interests:None declared

scholarly journals Efficacy of 5-Aminosalicylic Acid Enemas in the Treatment of Distal Ulcerative Colitis

1990 ◽  
Vol 4 (7) ◽  
pp. 468-471 ◽  
Author(s):  
MG Robinson ◽  
DL Decktor
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
First Episode ◽  
High Dose ◽  
Aminosalicylic Acid ◽  
Open Label ◽  
Distal Ulcerative Colitis ◽  
The Mean

The efficacy of 4 g 5-aminosalicylic acid (5-ASA, mesalamine) enemas was assessed in 666 patients with distal ulcerative colitis. Patients were enrolled in an open-label compassionate use program. One 4 g 5-ASA enema was administered each night for a period of four weeks and the disease activity index was assessed at baseline and on days 14 and 28. On days 14 and 28, 78.0% and 88.1% of patients, respectively, demonstrated an improvement in disease activity index. The mean decline in disease activity index on day 14 was 40.7% (P=0.0001) and on day 28 it was 55.4% (P=0.0001). Efficacy was similar whether the disease was confined to or extended beyond 30 cm from the anus. There was no difference in efficacy in patients suffering their first episode of disease compared to patients suffering subsequent attacks. In conclusion, high dose 5-ASA enemas are a highly effective treatment for distal ulcerative colitis.

scholarly journals DAPSA and ultrasound show different perspectives of psoriatic arthritis disease activity: results from a 12-month longitudinal observational study in patients starting treatment with biological disease-modifying antirheumatic drugs

RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000765 ◽  
Author(s):  
Silva Pukšić ◽  
Pernille Bolton-King ◽  
Joseph Sexton ◽  
Brigitte Michelsen ◽  
Tore K Kvien ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Clinical Assessment ◽  
Global Assessment ◽  
Activity Index ◽  
Power Doppler ◽  
Disease Activity Index ◽  
Patient Reported Outcome Measures ◽  
Joint Disease ◽  
Patient Reported

ObjectivesDisease Activity index for PSoriatic Arthritis (DAPSA) (sum score 68/66 tender/swollen joint counts (68TJC/66SJC), patient’s global assessment, pain and C-reactive protein (CRP)) is recommended for clinical assessment of disease activity in patients with psoriatic arthritis (PsA). Ultrasound (US) (grey scale (GS) and power Doppler (PD)) detects inflammation in joints and extra-articular structures. The present objectives were to explore the longitudinal relationships between DAPSA, clinical assessment as well as patient-reported outcome measures (PROMs) with US in patients with PsA initiating biological DMARDs and the associations between DAPSA and US remission.Methods47 patients with PsA were examined at baseline and after 3, 6, 9 and 12 months. Assessments included 68TJC/66SJC, examiner’s global assessment (EGA), PROMs, CRP, erythrocyte sedimentation rate (ESR) and US GS and PD (48 joints, 10 flexor tendons, 14 entheses, 4 bursae). Clinical composite scores and PD sum scores (0=remission) were calculated. Longitudinal associations were explored by generalised estimating equations with linear and logistic regression.ResultsDAPSA was not longitudinally associated to PD. 66SJC, ESR, 28-joint Disease Activity Score, EGA and CRP were longitudinally associated with PD (p<0.001–0.03), whereas the pain-related components of DAPSA (68TJC and pain) as well as PROMs were not associated. At 6–12 months, remission was achieved in 29%–33 % of the patients for DAPSA and 59%–70 % for PD. The association between DAPSA and PD remission was not significant (p=0.33).ConclusionsDAPSA was not associated with US inflammatory findings which indicates that DAPSA and US may assess different aspects of PsA activity.

scholarly journals A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

scholarly journals “From Where I Stand”: Using Multiple Anchors Yields Different Benchmarks for Meaningful Improvement and Worsening in the Rheumatoid Arthritis Flare Questionnaire (RA-FQ)

2021 ◽  
Author(s):  
Susan J. Bartlett ◽  
Vivian P. Bykerk ◽  
Orit Schieir ◽  
Marie-France Valois ◽  
Janet E Pope ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Activity Index ◽  
Disease Activity Index ◽  
Early Arthritis ◽  
Meaningful Change ◽  
Meaningful Improvement ◽  
Patient Reported ◽  
New Evidence

Abstract Purpose The Rheumatoid Arthritis Flare Questionnaire (RA-FQ) is a patient-reported measure of disease activity in RA. We estimated minimal and meaningful change from the perspective of RA patients, physicians, and using a disease activity index. Methods Data were from 3- and 6-month visits of adults with early RA enrolled in the Canadian Early Arthritis Cohort. Participants completed the RA-FQ, the Patient Global Assessment of RA, and Patient Global Change Impression at consecutive visits. Rheumatologists recorded joint counts and MD Global. Clinical Disease Activity Index (CDAI) scores were computed. We compared mean RA-FQ change across categories using patients, physicians, and CDAI anchors. Results The 808 adults were mostly white (84%) women (71%) with a mean age of 55 and moderate-high disease activity (85%) at enrollment. At V2, 79% of patients classified their RA as changed; 59% were better and 20% were worse. Patients reporting they were a lot worse had a mean RA-FQ increase of 8.9 points whereas those who were a lot better had a -6.0 decrease. Minimal worsening and improvement were associated with a mean 4.7 and -1.8 change in RA-FQ, respectively, while patients rating their RA unchanged had stable scores. Physician and CDAI classified more patients as worse than patients, and minimal and meaningful RA-FQ thresholds differed by group. Conclusion Thresholds to identify meaningful change vary by anchor used. These data offer new evidence demonstrating robust psychometric properties of the RA-FQ and offer guidance about improvement or worsening, supporting its use in RA care, research and decision-making.

Patient’s Global Assessment as an Outcome Measure for Psoriatic Arthritis in Clinical Practice: A Surrogate for Measuring Low Disease Activity?

2015 ◽  
Vol 42 (12) ◽  
pp. 2332-2338 ◽  
Author(s):  
Ennio Lubrano ◽  
Fabio Massimo Perrotta ◽  
Wendy J. Parsons ◽  
Antonio Marchesoni
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Outcome Measures ◽  
Global Assessment ◽  
Outcome Measure ◽  
Activity Index ◽  
Disease Activity Index ◽  
Secondary Outcome ◽  
Low Disease Activity

Objective.To assess the low disease activity (LDA) in a group of patients with psoriatic arthritis (PsA) receiving antitumor necrosis factor-α (TNF-α) by using the patient’s global assessment (PtGA) in clinical practice, and to compare PtGA with minimal disease activity (MDA) and other outcome measures.Methods.Patients with PsA classified by the ClASsification for Psoriatic ARthritis (CASPAR) criteria and consecutively admitted to an outpatient clinic dedicated to biologic therapy were assessed during their routine followup. The primary outcome measure was the proportion of patients achieving a PtGA ≤ 20 at 4-, 8-, and 12-month followups. Secondary outcome measures included the proportion of patients achieving MDA and other outcome measures. Correlation of PtGA with MDA and other process and outcome measures were also performed.Results.During the period of observation, 124 patients were evaluated. PtGA ≤ 20 was achieved in 25.7% at 4 months, 48.9% at 8 months, and 65.3% at 12 months of followup. The percentage of PtGA ≤ 20 statistically improved throughout the 3 timepoint assessments and it was statistically correlated to MDA. A significant correlation with the Disease Activity index for PSoriatic Arthritis (DAPSA), Bath Ankylosing Spondylitis Disease Activity Index, and Health Assessment Questionnaire was also observed. MDA, DAPSA, and Disease Activity Score at 28 joints with C-reactive protein remission were achieved at 12 months in 64%, 36%, and 71% of patients, respectively.Conclusion.PtGA can estimate the LDA status and could be considered as a surrogate of outcome measures for the assessment of global disease activity in patients with PsA receiving anti-TNF therapy during routine clinical practice. These data suggest that PtGA might be used in outpatient settings, being a simple, reliable, and not time-consuming instrument.

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