TREATMENT OF RHEUMATOID ARTHRITIS IN BASRAH: CLINICAL EFFICACY AND TOXICITY OF SULFASALAZINE USED ALONE OR IN COMBINATION WITH DICLOFENAC SODIUM
The Medical Journal of Basrah University,
2008, Volume 26, Issue 2, Pages 97-102
Background: Racial variation in the clinical presentation of rheumatoid arthritis (RA) and its response to treatment
is well known. Ethnicity and associated socioeconomic factors make it necessary to study the effectiveness of the antirheumatic
drugs such as sulfasalazine (SSZ) in our RA patients, and to what extent it interacts with the nonsteroidal
anti-inflammatory drug (NSAID); diclofenac.
Objective: To investigate the efficacy and toxicity of sulfasalazine alone or in combination with diclofenac in the
treatment of moderate to severe RA.
Methods: A three month-randomized clinical trial was conducted on patients with moderate to severe RA: Group I:
received SSZ (500 mg orally twice daily), and Group II: received SSZ plus diclofenac sodium 100mg SR tablets once
daily. Evaluation involved: pain, morning stiffness, joint function, patients and physician global assessment,
radiological assessment, ACR criteria, laboratory findings and drug adverse effects.
Results: Only 17 patients out of 20, managed to complete the 12 week treatment course. Oral SSZ (500mg twice
daily for 3 months) resulted in a statistically significant clinical improvement after 12 weeks of treatment. The
average percent improvement in six clinical parameters was 21.1%. The 20% improvement using ACR criteria
involved 11% of patients. The improvement occurred especially in the number of swollen joints and in joint pain. The
overall improvement that occurred two weeks after treatment with SSZ continued at the same level over the 12 week
treatment period. No statistically significant changes were detected in the laboratory parameters measured including
ESR. No radiological progression was found 12 weeks after treatment in joint space narrowing and joint erosion. SSZ
reduced symptoms reported by patients before treatment by 57.4%. Diclofenac as a sustained release formulation
administered concomitantly with SSZ did not change the improvement caused by SSZ as measured by the six clinical
parameters (23% versus 23.4%). However, the ACR20 increased from 11% to 25%. No effect on laboratory
measurements was found. Diclofenac in combination with SSZ reduced the symptoms reported by patients by 70.6%
compared with 57.4% by SSZ alone.
Conclusion: SSZ treatment for 12 weeks caused mild to moderate improvement in all measured clinical parameters,
especially in the number of swollen joints and in joint pain. Diclofenac as a sustained release formulation, given with
SSZ, did not change the improvement caused by SSZ as measured by six clinical parameters, although it increased
the ACR20 of SSZ from 11% to 25%.
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