Anticytokine therapies in rheumatic diseases: an update
Rajan Madhok, Hilary Capell in The Year in Rheumatic Disorders Volume 4, 2004
(n = 16) for 6 weeks; all patients received etanercept in the subsequent observational phase, lasting 24 weeks. DMARDs and steroids were withdrawn prior to the study. The primary outcome measure was a 50% improvement in the Bath AS Disease Activity Index (BASDAI), an index of disease activity that evaluates fatigue, pain and stiffness. Ancillary outcome measures included the Bath AS Functional Index (BASFI), which evaluates the impact of disability on different activities of daily living, the Bath AS Metrology Index (an index of spinal mobility), pain level on a numeric rating scale, quality of life (using the Short Form 36), and C-reactive protein levels. Fifty-seven per cent of the etanercept-treated patients but only 6% of patients receiving placebo (P = 0.004) had a 50% improvement in the BASDAI at week 6 (Fig. 3.4); when the placebo-treated patients switched to etanercept, 56% improved. Similarly, the other outcome variables improved significantly with etanercept but not with placebo at week 6. Disease relapses occurred on average 6 weeks after cessation of etanercept therapy. No severe adverse events were observed.
Ankylosing spondylitis
John M. Saxton in Exercise and Chronic Disease, 2011
Five trials (Altan et al., 2006; Analay et al., 2003; Cagliyan et al., 2007; Hidding et al., 1993; Karapolat et al., 2008) compared supervised with non-supervised exercise. Effect sizes for the supervised groups were generally higher for all the patient reported outcome measures. For the supervised groups, the mean effect size changes for BASDAI/pain, BASFI and global assessment (BAS-G) were 0.75, 0.60 and 1.1 respectively, in comparison to 0.43, 0.21 and 0.56, respectively, for the non-supervised groups. Two of the trials were judged to have five PEDro points, one with four and one with seven PEDro points (Table 11.1), indicating that there is moderate evidence for large effect of supervised exercise programmes on patient reported outcome measures.
Axial Spondyloarthritis
Jason Liebowitz, Philip Seo, David Hellmann, Michael Zeide in Clinical Innovation in Rheumatology, 2023
Over the past ten years, we have seen some small shifts in the measures used to monitor AxSpA. Within clinical trials, the ASAS criteria for 20% or 40% improvement, while often preferred by regulatory bodies such as the FDA and the European Medicines Agency as the primary outcome, is now consistently accompanied by the Ankylosing Spondylitis Disease Activity Score (ASDAS), which is felt to have greater content and construct validity as well as greater responsiveness.50 In the next ten years, we may see these measures reverse in importance. We have also seen reduced importance of the physical examination maneuvers, including the Bath Ankylosing Spondylitis Metrology Index in trials, particularly as they change slowly and have low responsiveness within trials.50 The most commonly used outcome measure in clinical practice remains the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). However, studies within the United States have pointed to the potential validity of the Routine Assessment of Patient Index Data 3 (RAPID3) for monitoring AxSpA and use of patient-reported outcome measures (PROMIS) in AxSpA for monitoring physical function and quality of life, measures that are more commonly used in the United States than in other parts of the world.51–56 Only one study to date has examined PROMIS measures in AxSpA.56 Finally, the largest contribution to outcome measures in the past ten years has been the development of the ASAS Health Index (HI).57 The ASAS HI is a measure of quality of life specific to AxSpA. It has excellent measurement properties, including responsiveness.
Assessment of effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting for treatment of patients with active rheumatoid arthritis or ankylosing spondylitis
Published in Current Medical Research and Opinion, 2018
Cătălin Codreanu, Klára Šírová, Katerina Jarošová, Anastas Batalov
The number of patients in remission or low disease activity at 24 weeks was also evaluated using established criteria. In RA, remission is defined as a DAS28 score of <2.6 points and low disease activity is defined as a DAS28 score of <3.2 points23,24. In AS, low disease activity is defined as a BASDAI score of ≤3 points25. As the Bath Ankylosing Spondylitis Functional Index was not applied in this study, response/remission as per ASAS was not available and, instead, remission criteria based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) were applied: 0.12 × Back Pain +0.06 × Duration of Morning Stiffness +0.11 × Patient Global +0.07 × Peripheral Pain/Swelling +0.58 × Ln(CRP +1)26–28. Remission was defined as an ASDAS score of <1.3 points25,29.
Real-world effectiveness and safety of adalimumab for treatment of ankylosing spondylitis in Japan
Published in Modern Rheumatology, 2019
Shigeto Kobayashi, Tomoko Kashiwagi, Junko Kimura
A total of 403 patients were prospectively enrolled in the study; there were 396 and 374 patients in the safety and effectiveness analysis sets, respectively (Figure 1). In the safety analysis set, most patients were male (n = 266, 67.2%), with a mean (standard deviation [SD]) age of 46.3 (15.6) years, body weight of 63.2 (13.4) kg, and disease duration of 9.8 (9.8) years (Table 1). Further, most of the patients (90.7%) were outpatients. Among 292 patients with BASDAI score at baseline, the mean (SD) BASDAI score was 4.9 (2.3), and about one-half of the patients (48.2%) had a BASDAI score ≥4. Among 236 patients with known HLA-B27 status, 131 (55.5%) were HLA-B27–positive. Comorbid conditions, including extra-articular manifestations of AS, were present in many patients (n = 231, 58.3%), and most were taking concomitant medications (n = 369, 93.2%) (Table 1).
Efficacy and safety of adalimumab in Japanese patients with psoriatic arthritis and inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs): A prospective, observational study
Published in Modern Rheumatology, 2020
Akimichi Morita, Ryuhei Okuyama, Norito Katoh, Chiharu Tateishi, Koji Masuda, Toshifumi Komori, Eisaku Ogawa, Takamitsu Makino, Emi Nishida, Shohei Nishimoto, Kenzo Muramoto, Daisuke Tsuruta, Hironobu Ihn
In the present study, BASDAI scores significantly decreased from baseline to weeks 12 and 24. As PsA has peripheral and axial clinical manifestations [35], the diagnosis of spinal involvement in PsA or axial PsA presents a clinical and classification challenge. BASDAI is used for measuring disease activity of axial diseases such as ankylosing spondylitis and axial PsA [35–37], but not peripheral PsA; therefore, it is generally not considered useful for measuring PsA disease activity. Consequently, the observed decrease in BASDAI scores may have occurred because the percentage of patients with spondylitis (axial PsA) was high in the current study and higher than in ADEPT (21.6% in current study, 0.7% in ADEPT). Indices that measure only peripheral joint activity such as the DAS and ACR response criteria may be inadequate in capturing disease activity associated with axial PsA. Therefore, a tool such as BASDAI may be useful to assess complete disease activity. However, further studies are required to confirm the usefulness of BASDAI in measurement of PsA disease activity.
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