Treatment of active ankylosing spondylitis with abatacept: an open-label, 24-week pilot study

2011 ◽  
Vol 70 (6) ◽  
pp. 1108-1110 ◽  
Author(s):  
I-H Song ◽  
F Heldmann ◽  
M Rudwaleit ◽  
H Haibel ◽  
A Weiß ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Pilot Study ◽  
Activity Index ◽  
Disease Activity Index ◽  
Inadequate Response ◽  
Open Label ◽  
Tnfα Inhibitor ◽  
Group 2 ◽  
Activity Index Score ◽  
Group 1

ObjectiveTo prospectively explore the short-term efficacy and safety of abatacept in patients with ankylosing spondylitis (AS).MethodsIn this prospective open-label pilot study, abatacept (10 mg/kg) was administered intravenously on days 1, 15, 29 and every 28 days thereafter up to week 24 in 15 tumour necrosis factor α (TNFα)-inhibitor naive patients (group 1) and 15 patients with inadequate response to TNFα inhibitors (group 2) with active AS. The primary end point was the proportion of patients with 40% improvement according to the Assessment of SpondyloArthritis international Society criteria (ASAS40) in both groups at week 24.ResultsAt week 24, ASAS40 was reached by 13% of group 1 and 0% of group 2; 20% improvement (ASAS20) was reached by 27% and 20%, respectively. There was no significant change of Bath Ankylosing Spondylitis Disease Activity Index score, patient global assessment or C reactive protein. Overall, abatacept was well tolerated.ConclusionsIn this pilot open-label AS study a major response was not observed.

scholarly journals Clinical features of ankylosing spondylitis in patients with secondary AA amyloidosis

2020 ◽  
Vol 14 (3) ◽  
pp. 45-49
Author(s):  
D. G. Rumyantseva ◽  
E. M. Agafonova ◽  
S. O. Krasnenko ◽  
A. S. Starkova ◽  
M. M. Urumova ◽  
...  
Keyword(s):  
New York ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Clinical Features ◽  
Activity Index ◽  
Disease Activity Index ◽  
Clinical Feature ◽  
Aa Amyloidosis ◽  
Group 2 ◽  
Group 1

Renal AA amyloidosis is the most severe type of renal pathology in patients with ankylosing spondylitis (AS). The characteristic symptoms of AA amyloidosis in rheumatic diseases do not often occur for years, making it difficult to diagnose it early and to start adequate therapy.Objective: to identify the clinical features of AS complicated by secondary AA amyloidosis.Patients and methods. The investigation enrolled 9 patients with AS (according to the 1984 modified New York criteria) and histologically confirmed secondary AA amyloidosis (Group 1). A comparison group included 216 AS patients without amyloidosis (Group 2).Results and discussion. In Group 1 patients, the age at the onset of AS was significantly less and the disease duration was 4 times longer than those in Group 2. All the patients with AA amyloidosis had enthesitis and arthritis, including those of the hip joints. The scores of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP), and the acute phase inflammation index CRP were higher in Group 1 than in Group 2.Conclusion. The clinical feature of AS complicated by secondary AA-amyloidosis is the long duration of the disease and the high frequency of juvenile onset, non-axial manifestations (arthritis, coxitis and enteritis), as well as the high activity of systemic inflammation.

scholarly journals Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-week results of the GO-RAISE study

2011 ◽  
Vol 71 (5) ◽  
pp. 661-667 ◽  
Author(s):  
Jürgen Braun ◽  
Atul Deodhar ◽  
Robert D Inman ◽  
Désirée van der Heijde ◽  
Michael Mack ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Safety Profile ◽  
Activity Index ◽  
Disease Activity Index ◽  
Subcutaneous Injections ◽  
Treatment Regimens ◽  
Group 3 ◽  
Group 2 ◽  
Necrosis Factor ◽  
Group 1

ObjectiveTo assess the efficacy and safety of golimumab over 104 weeks in patients with active ankylosing spondylitis.MethodsAt baseline, patients with active ankylosing spondylitis (n=356) were randomly assigned (1:1.8:1.8) to subcutaneous injections of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3) every 4 weeks. At week 16, patients in groups 1 and 2 with <20% improvement in total back pain and morning stiffness entered early escape to 50 or 100 mg, respectively. At week 24, patients still receiving placebo crossed over to golimumab 50 mg. Findings through week 24 were previously reported; those through week 104 are presented herein.ResultsAt week 104, 38.5%, 60.1% and 71.4% of patients in groups 1, 2 and 3, respectively, had at least 20% improvement in the Assessment in SpondyloArthritis international Society response criteria (ASAS20); 38.5%, 55.8% and 54.3% had an ASAS40 response and 21.8%, 31.9% and 30.7% were in ASAS partial remission. Mean Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores were <3 at week 104 for all the treatment regimens. Golimumab safety through week 104 was similar to that through week 24.ConclusionClinical response that was achieved by patients receiving golimumab through 24 weeks was sustained through 52 and 104 weeks. The golimumab safety profile appeared to be consistent with the known safety profile of tumour necrosis factor inhibitors.

scholarly journals Comparison of Deep Tissue Massage and Therapeutic Massage for Lower Back Pain, Disease Activity, and Functional Capacity of Ankylosing Spondylitis Patients: A Randomized Clinical Pilot Study

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Mateusz Wojciech Romanowski ◽  
Maja Špiritović ◽  
Radosław Rutkowski ◽  
Adrian Dudek ◽  
Włodzimierz Samborski ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Pilot Study ◽  
Disease Activity ◽  
Pain Intensity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Deep Tissue ◽  
Therapeutic Massage ◽  
Lower Back ◽  
Clinical Benefits

Objectives. This study aims to compare the effectiveness of deep tissue massage (DTM) and therapeutic massage (TM) in the management of ankylosing spondylitis (AS) patients. Materials and Methods. This was a small, randomized clinical pilot study. Subjects were 27 men with diagnosed AS, randomly assigned to DTM group or TM group. Subjects in each group had 10 sessions of massage. Outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), Modified Schober Test, Finger to Floor Test, chest expansion, and pain intensity of lower back. Results. There are no statistical significant differences between groups, except for BASDAI and pain intensity of lower back. Conclusions. This study suggests that massage may have clinical benefits for treating ankylosing spondylitis patients. Additional scientific research in this area is warranted.

Azithromycin and metronidazole versus metronidazole-based therapy for the induction of remission in mild to moderate paediatric Crohn’s disease : a randomised controlled trial

Gut ◽  
2018 ◽  
Vol 68 (2) ◽  
pp. 239-247 ◽  
Author(s):  
Arie Levine ◽  
Michal Kori ◽  
Jarek Kierkus ◽  
Rotem Sigall Boneh ◽  
Malgorzata Sladek ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Randomised Controlled Trial ◽  
Crohn's Disease ◽  
Activity Index ◽  
Controlled Trial ◽  
Open Label ◽  
Faecal Calprotectin ◽  
Group 2 ◽  
Randomised Controlled ◽  
Group 1

ObjectiveCrohn’s disease (CD) pathogenesis associated with dysbiosis and presence of pathobionts in the lumen, intracellular compartments and epithelial biofilms. Azithromycin is active in all three compartments. Our goal was to evaluate if azithromycin-based therapy can improve response and induce remission compared with metronidazole alone in paediatric CD.DesignThis blinded randomised controlled trial allocated children 5–18 years with 10<Pediatric Crohn’s Disease Activity Index (PCDAI)≤40 to azithromycin 7.5 mg/kg, 5 days/week for 4 weeks and 3 days/week for another 4 weeks with metronidazole 20 mg/kg/day (group 1) or metronidazole alone (group 2), daily for 8 weeks. Failures from group 2 were offered azithromycin as open label. The primary end point was response defined by a decrease in PCDAI>12.5 or remission using intention to treat analysis.Results73 patients (mean age 13.8±3.1 years) were enrolled, 35 to group 1 and 38 to group 2. Response and remission rates at week 8 were identical 23/35 (66%) in group 1 and 17/38 (45%) and 15/38 (39%) in group 2 (P=0.07 and P=0.025, respectively). The needed to treat for remission was 3.7. Faecal calprotectin declined significantly in group 1 (P=0.003) but not in group 2 (p=0.33), and was lower at week 8 (P=0.052). Additional therapy was required in 6/35(17%) from group 1 versus 16/38(42%) in group 2 (P=0.027) by week 8. Among 12 failures in group 2, open-label azithromycin led to remission in 10/12 (83%).ConclusionsThe combination of azithromycin and metronidazole failed to improve response but was superior for induction of remission and reduction in calprotectin.Trial registration numberNCT01596894.

scholarly journals Maintained Clinical Remission in Ankylosing Spondylitis Patients Switched from Reference Infliximab to Its Biosimilar: An 18-Month Comparative Open-Label Study

2019 ◽  
Vol 8 (7) ◽  
pp. 956 ◽  
Author(s):  
Kaltsonoudis Evripidis ◽  
Pelechas Eleftherios ◽  
Voulgari V. Paraskevi ◽  
Drosos A. Alexandros
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Clinical Remission ◽  
Activity Index ◽  
Disease Activity Index ◽  
Control Group ◽  
Nocebo Effect ◽  
Open Label

Background: Switching from reference infliximab (RI) to biosimilar infliximab (BI) had no detrimental effects on efficacy and safety. However, long-term follow-up data is missing. Objective: To evaluate patients with Ankylosing Spondylitis (AS) in clinical remission who were switching from RI to BI, in terms of the safety and efficacy of this, in a long-term fashion. Methods: One hundred and nine consecutive unselected AS patients were investigated. All were naïve to other biologics and were followed-up at predefined times receiving RI. Patients in clinical remission were asked to switch from RI to BI. Those who switched to BI were compared with a matched control-group receiving continuous RI. During follow-up, several parameters were recorded for at least 18 months. Disease activity was measured using the Bath Ankylosing Spondylitis disease activity index (BASDAI), and the Ankylosing Spondylitis disease activity score (ASDAS), using the C-reactive protein. Remission was defined as BASDAI < 4 and ASDAS < 1.3. Results: Eighty-eight patients were evaluated (21 excluded for different reasons). From those, 45 switched to BI, while 43 continued receiving RI. No differences between groups regarding demographic, clinical and laboratory parameters were observed. All patients were in clinical remission. During follow-up, five patients from the BI-group and three from the maintenance-group discontinued the study (4 patients nocebo effect, 1 loss of efficacy). After 18 months of treatment, all patients in both groups remained in clinical remission. No significant adverse events were noted between groups. Conclusion: BI is equivalent to RI in maintaining AS in clinical remission for at least 18 months.

Biosimilars in Saudi Arabia: a single-centre, open-label case series examining infliximab switching

2021 ◽  
Vol 10 (2) ◽  
pp. 68-71
Author(s):  
Mansour Somaily ◽  
Hana Alahmari ◽  
Wejdan Abbag ◽  
Shahenda Yousif ◽  
Nawar Tayfour ◽  
...  
Keyword(s):  
Saudi Arabia ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Activity Index ◽  
Case Series ◽  
Disease Activity Index ◽  
Local Data ◽  
Open Label ◽  
One Year

Background: A biosimilar version of infliximab ( CT-P13) was recently approved for use in Saudi Arabia. Clinical data support its use in the treatment of rheumatic disease, however, there is a lack of local data regarding the efficacy and tolerability of CT-P13 among patients with rheumatological disorders in Saudi Arabia. Objectives: To investigate the feasibility, tolerability and immunogenicity of switching from originator infliximab to biosimilar infliximab, CT-P13, in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and Behçet’s disease (BD). Methodology: The study included patients who were being treated with originator infliximab in the Department of Rheumatology in Khamis Mushayt General Hospital, Saudi Arabia, and were required to switch to biosimilar infliximab (CT-P13) between January 2018 and June 2019. Patient follow-up was carried out every three months for one year. The disease activity score 28 (DAS28) was used to assess RA severity. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score was used to measure disease activity in patients with AS, while BD disease activity was based on clinical assessment. Results: In total, 13 patients (six with RA, five with AS and two with BD) were switched to biosimilar infliximab. The majority (n = 11/13) remained on biosimilar infliximab throughout the follow-up period with no reported major adverse events. Overall, there was a significant improvement in RA disease activity following biosimilar treatment, with the mean DAS28 decreasing from 3.61±1.24 before biosimilar therapy to 2.63±1.54 one year after switching. Conclusion: In patients with AS, BD, or RA who switched from originator infliximab to the biosimilar, CT-P13, we did not observe any significant differences in tolerability or efficacy between biosimilar and originator. Furthermore, disease activity significantly declined in RA patients following biosimilar treatment

Effects of Homoeopathic Single and Minimum Dose on Non-Radiographic Axial Spondyloarthritis—BASDAI Assessment

2020 ◽  
Vol 33 (01) ◽  
pp. 041-052
Author(s):  
Deepak Kumar ◽  
Eiphrangdaka L. Suchiang ◽  
Gautam Pal
Keyword(s):  
Ankylosing Spondylitis ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Low Back ◽  
Beneficial Effects ◽  
Mild Disease ◽  
Minimum Dose ◽  
Before And After ◽  
Activity Index Score

AbstractEarly cases of ankylosing spondylitis do not have the typical presentation of radiographic sacroiliitis but present as non-radiographic axial spondyloarthritis (nr-axSpA) where both are varieties of axSpA. Homoeopathic prescription based on totality of symptoms offers a promising relief to nr-axSpA where peripheral joints are also affected. Here, a 27-year-old male patient presented with bilateral heel pain, pain in low back, pain on base of right toes, pain in neck with stiffness for 1 year had refractive response to conventional medication. Diagnosis was confirmed by Assessment of SpondyloArthritis International Society diagnostic criteria for axSpA. Single medicine and minimum dose of Silicea showed its effectiveness on the symptoms' improvement and Bath Ankylosing Spondylitis Disease Activity Index score whereby score of 8.8 (active disease) before treatment changed to 1.2 (inactive or mild disease) after treatment. Various other parameters were assessed accordingly before and after treatment. This case report encourages further exploring the beneficial effects of homoeopathic treatment in clinical condition like axSpA utilising validated scale.

Association of IL-12B Genetic Polymorphism with the Susceptibility and Disease Severity of Ankylosing Spondylitis

2011 ◽  
Vol 39 (1) ◽  
pp. 135-140 ◽  
Author(s):  
RUEY-HONG WONG ◽  
JAMES CHENG-CHUNG WEI ◽  
CHUN-HUANG HUANG ◽  
HONG-SHEN LEE ◽  
SHANG-YAN CHIOU ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Disease Severity ◽  
Activity Index ◽  
Disease Activity Index ◽  
T Helper 17 ◽  
Tyrosine Kinase 2 ◽  
Polymerase Chain ◽  
Activity Index Score ◽  
Interleukin 23

Objective.Interleukin 23 (IL-23) stimulates the differentiation of T helper 17 (Th17) cells, which are involved in the pathogenesis of ankylosing spondylitis (AS). Binding of IL-23 to the IL-23 receptor complex activates Janus kinases 2 and tyrosine kinase 2, which phosphorylate IL-23R and subsequently promote the transcription of the IL-17 gene. IL-12B encodes a p40 subunit common to IL-12 and IL-23. We evaluated the effects of IL-12B and IL-23R genotype on the occurrence and clinical features of AS.Methods.A total of 362 patients with AS and 362 healthy controls were enrolled in the study. Genotypes of IL-12B A1188C (rs3212227) and IL-23R C2370A (rs10889677) were identified by polymerase chain reaction/restriction fragment-length polymorphism. Disease activity and functional status were assessed by Bath AS indices.Results.Subjects carrying IL-12B CC [matched relative risk (RRm) 1.93, 95% CI 1.23–3.03] and IL-12B AC (RRm 1.73, 95% CI 1.21–2.46) genotypes had a significantly greater risk of developing AS than subjects with the IL-12B AA genotype. Subjects carrying both IL-12B CC and IL-23R AA genotypes also had a significantly higher risk (RRm 2.98, 95% CI 1.51–5.89) of developing AS compared to those with IL-12B AA and IL-23R CC/CA genotypes, and this interaction between IL-12B and IL-23R was significant. Patients with AS who had IL-12B CC and IL-12B AC genotypes had an obviously increased Bath Ankylosing Spondylitis Disease Activity Index score compared to those who carried the IL-12B AA genotype (4.3 vs 3.7).Conclusion.The IL-12B A1188C genotype was associated with the development and disease severity of AS.

Physical Function and Spinal Mobility Remain Stable Despite Radiographic Spinal Progression in Patients with Ankylosing Spondylitis Treated with TNF-α Inhibitors for Up to 10 Years

2016 ◽  
Vol 43 (12) ◽  
pp. 2142-2148 ◽  
Author(s):  
Denis Poddubnyy ◽  
Aleksandra Fedorova ◽  
Joachim Listing ◽  
Hildrun Haibel ◽  
Xenofon Baraliakos ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Structural Damage ◽  
Activity Index ◽  
Strong Association ◽  
Disease Activity Index ◽  
Spinal Mobility ◽  
Continuous Control ◽  
Open Label ◽  
Tnf Α

Objective.The aim of the study was to investigate the effect of radiographic spinal progression and disease activity on function and spinal mobility in patients with ankylosing spondylitis (AS) treated with tumor necrosis factor-α (TNF-α) inhibitors for up to 10 years.Methods.Patients with AS who participated in 2 longterm open-label extensions of clinical trials with TNF-α inhibitors (43 receiving infliximab and 17 receiving etanercept) were included in this analysis based on the availability of spinal radiographs performed at baseline and at a later timepoint (yr 2, 4, 6, 8, and 10) during followup. Spinal radiographs were scored according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Function was assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI), spinal mobility by the Bath Ankylosing Spondylitis Metrology Index (BASMI), and disease activity by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).Results.After the initial improvement, BASFI and BASMI remained remarkably stable at low levels over up to 10 years despite radiographic spinal progression. In the generalized mixed effects model analysis, no association between the mSASSS and the BASFI change (β = 0.0, 95% CI −0.03 to 0.03) was found, while there was some effect of mSASSS changes on BASMI changes over time (β = 0.05, 95% CI 0.01–0.09). BASDAI showed a strong association with function (β = 0.64, 95% CI 0.54–0.73) and to a lesser extent, with spinal mobility (β = 0.14, 95% CI 0.01–0.26).Conclusion.Functional status and spinal mobility of patients with established AS remained stable during longterm anti-TNF-α therapy despite radiographic progression. This indicates that reduction and continuous control of inflammation might be able to outweigh the functional effect of structural damage progression in AS.

scholarly journals Early response to adalimumab predicts long-term remission through 5 years of treatment in patients with ankylosing spondylitis

2011 ◽  
Vol 71 (5) ◽  
pp. 700-706 ◽  
Author(s):  
Joachim Sieper ◽  
Désirée van der Heijde ◽  
Maxime Dougados ◽  
L Steve Brown ◽  
Frederic Lavie ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Early Response ◽  
Inactive Disease ◽  
Sustained Remission ◽  
Efficacy And Safety ◽  
Open Label

ObjectivesTo describe the efficacy and safety through 5 years of adalimumab treatment in patients with ankylosing spondylitis (AS), and to identify predictors of remission.MethodsPatients with active AS were followed up to 5 years during a 24-week randomised, controlled period, followed by an open-label extension. Disease activity and clinical improvement were evaluated by Assessment in Spondyloarthritis International Society (ASAS) responses, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS). Kaplan–Meier was used to identify patients with sustained ASAS partial remission (PR) or ASDAS inactive disease (ID) for three or more consecutive visits spanning ≥6 months. Logistic regression was used to identify factors associated with remission. Explanatory variables included baseline demographic and disease characteristics and week 12 responses.ResultsOf the 311 patients who received at least one dose of adalimumab, 202 (65%) completed the 5-year study. Among 125 patients who received 5 years of adalimumab, 70%, 77%, 51% and 61% achieved ASAS40, BASDAI 50, ASAS PR and ASDAS ID, respectively. Of 311 adalimumab-treated patients, 45% and 55% achieved sustained ASAS PR and ASDAS ID at any time during study participation. The strongest predictor of remission at years 1 and 5 and of sustained remission was achieving remission at 12 weeks of treatment; baseline characteristics showed weaker associations. Adverse events were comparable with previous reports on adalimumab safety.ConclusionsIn patients with active AS, the efficacy and safety of adalimumab were maintained through 5 years with about half of the patients experiencing sustained remission at any time during the study. Early achievement of remission was the best predictor of long-term and sustained remission.

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