Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Assessment of Efficacy and Safety of Pamidronate in Undifferentiated Spondyloarthropathy (uSpA): A Placebo Control Trial in a Tertiary Level Centre.
Sarkar1, Rathindra N., Phaujdar2, Sibaji, Siddhanta2, Sattik, Banerjee2, Siwalik, De2, Dibeyendu, Bhattacharyya2, Kuntal, Pal2, H. K.
Undifferentiated spondyloarthropathy (uSpA) represents an incomplete form or early phase of Ankylosing spondylitis (AS) or another distinct type of spondyloarthropathy, whereas nonsteroidal anti-inflammatory drugs (NSAIDs) and disease modifying anti-rheumatic drugs (DMARDs) are still mainstay of treatment, tumour necrosis factor antagonists have shown good results in patients (pts) with severe symptoms or axial involvement but are very expensive and suppresses immunity. Pamidronate, an aminobisphosphonate, has shown anti-tumour necrosis factor properties. We evaluated efficacy and safety of Pamidronate in Indian uSpA pts refractory to NSAIDs therapy.
Fifty four pts fulfilling the modified Amor criteria for diagnosis of uSpA, having active disease even after 3 month's continuous therapy with two NSAIDs in maximal dose were selected. Active disease was defined as a Visuo-Analogue Scale (VAS) >50 (0100mm scale) in 3 out of 4 following parameters: pts' global assessment, pain, Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI-morning stiffness). Patients receiving Sulfasalazine, 23g orally per day for peripheral arthritis were allowed to continue.
Patients were divided into Pamidronate group (N=40, received 60 mg monthly i.v. infusion in 500 ml Normal saline) and Placebo group (N=14, received Normal saline monthly i.v. infusion). Pts allowed continuing the analgesics. Efficacy assessment at the baseline and at 6-month was done using BASMI, BASFI, BASDAI, Bath Ankylosing Spondylitis Global Score (BAS-G), CRP and ESR. Proportion of pts achieving ASAS-20 and BASDAI-50 were also recorded at 6 months. Pts were observed for any AE. This study has clearance from Institutional Ethics Committee.
Pts with USpA (n=54, M: F: 8:1), mean (SD) age was 46.54 (8.57) years, mean (SD) disease duration was 3.94 (1.14) years. Baseline characteristics and the disease activity in both treatment groups were similar. Changes in the parameters from baseline to 6 months in both groups are as described in Table 1. In Pamidronate group, there was significant reduction in all parameters compared to baseline while 32 pts (80 %) achieved ASAS-20 and 27 pts (67.5 %) achieved BASDAI-50 response, Pts in the placebo group showed increase in all the parameters. Very early feel good response was found in 23 pts (57.5 %) within 36 hours of first Pamidronate infusion. Mild fever, arthralgia, myalgia noted in 7 (17.5%) pts after first dose and in 3 cases (7.5 %) after second dose of Pamidronate.
Table 1. Clinical and laboratory parameters at baseline and 6 months
Pamidronate appears to be effective treatment option for pts with uSpA with acceptable safety profile.
To cite this abstract, please use the following information:
Sarkar, Rathindra N., Phaujdar, Sibaji, Siddhanta, Sattik, Banerjee, Siwalik, De, Dibeyendu, Bhattacharyya, Kuntal, et al; Assessment of Efficacy and Safety of Pamidronate in Undifferentiated Spondyloarthropathy (uSpA): A Placebo Control Trial in a Tertiary Level Centre. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1925