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COMPARATIVE EFFICACY AND SAFETY OF BIOLOGIC VERSUS
NON-BIOLOGIC THERAPIES IN THE MANAGEMENT OF REACTIVE
ARTHRITIS: A 52-WEEK COHORT STUDY
Abdujabborov Jamshidbek
Omonov Jamshid
Tursunboev Ulugbek
Kushboeva Shabnam
Abdurakhmanova Sayyora
https://doi.org/10.5281/zenodo.15192883
Introduction
Reactive Arthritis (ReA) is a form of seronegative spondyloarthritis often
triggered by infections, primarily from the gastrointestinal or urogenital tracts.
The disease is characterized by the sudden onset of asymmetric oligoarthritis,
leading to significant pain, reduced mobility, and a decline in the quality of life
(Sieper et al., 2002). While conventional therapies, including nonsteroidal anti-
inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs
(DMARDs), are commonly used in the management of ReA, biologic therapies—
especially tumor necrosis factor-alpha (TNF-α) inhibitors—have emerged as a
promising alternative in treating refractory cases (Braun & Sieper, 2007).
Despite the potential of biologic agents, their high cost and the risk of adverse
effects require careful consideration, particularly in resource-limited settings
(Coates et al., 2016). This study aims to compare the efficacy and safety of
biologic therapies, specifically TNF-α inhibitors, to conventional non-biologic
therapies in patients with ReA. The research seeks to provide empirical evidence
that will guide clinicians in selecting the most appropriate treatment options for
managing ReA.
Materials and Methods
This study employed a prospective cohort design to compare biologic and
non-biologic therapies in the treatment of ReA. The study enrolled 60 patients
diagnosed with ReA, as per established clinical and laboratory criteria. The
patients were recruited from rheumatology clinics and divided into two groups:
30 patients received biologic therapies (TNF-α inhibitors, such as etanercept or
adalimumab), while 30 patients were administered conventional DMARDs,
including methotrexate and sulfasalazine. Inclusion criteria required
participants to be between 18 and 65 years old and present with active ReA
symptoms for a minimum of three months. Exclusion criteria included a history
of other autoimmune diseases, prior use of biologic therapies, or
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contraindications to study medications. Patients were allowed to use NSAIDs
and corticosteroids as rescue medications.
The primary outcome measure was the change in Disease Activity Score
(DAS28) over a 52-week period, which is a standard assessment of disease
activity in inflammatory arthritis. Secondary outcomes included remission rates
(defined as a DAS28 score of less than 2.6), quality of life, and the incidence of
adverse events. Quality of life was evaluated using the Health Assessment
Questionnaire (HAQ). Clinical assessments were conducted at baseline, 12
weeks, 26 weeks, and 52 weeks, including joint counts, patient-reported
outcomes, and laboratory tests such as erythrocyte sedimentation rate (ESR)
and C-reactive protein (CRP). Statistical analyses were performed using t-tests,
Mann-Whitney U tests, chi-square tests, and repeated-measures ANOVA, with a
significance level set at p < 0.05.
Results
At baseline, the demographic characteristics of the two groups were
comparable. The average age of the participants was 38.5 years, with 65% of the
cohort being male. The mean DAS28 score was 5.8, indicating a high level of
disease activity in both groups. Over the 52-week study period, the biologic
group showed significantly greater improvements in disease activity, as
measured by DAS28 scores, compared to the non-biologic group. Specifically, the
mean reduction in DAS28 was 2.8 ± 0.6 in the biologic group, compared to 1.9 ±
0.7 in the non-biologic group (p < 0.05). Remission was achieved by 70% of
patients in the biologic group, compared to 50% in the non-biologic group (p =
0.03). Additionally, the biologic group exhibited more significant improvements
in quality of life, with a mean HAQ score change of -1.2 ± 0.3 versus -0.8 ± 0.4 in
the non-biologic group (p < 0.05).
In terms of adverse events, 25% of patients in the biologic group
experienced side effects, most commonly injection site reactions (10%). In the
non-biologic group, 40% of patients reported adverse events, with
gastrointestinal discomfort being the most frequent (20%). Serious adverse
events were rare in both groups, with similar rates of occurrence. Subgroup
analyses revealed that patients with shorter disease durations (less than 12
months) responded more favorably to biologic therapy, as did patients with
higher baseline CRP levels.
Conclusion
The findings from this 52-week cohort study suggest that biologic
therapies, specifically TNF-α inhibitors, are more effective than conventional
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non-biologic therapies in reducing disease activity and achieving remission in
patients with Reactive Arthritis (ReA). Patients receiving biologic therapies also
reported a higher quality of life, underscoring the benefits of these therapies
beyond symptom control. Although biologics carry a higher cost, their superior
efficacy and generally acceptable safety profile make them a viable option for
treating moderate to severe ReA, especially for patients who fail conventional
treatments. However, the risk of mild adverse events, such as injection site
reactions, and the higher cost of biologic treatments remain significant
considerations. This study’s strengths include its rigorous methodology and
detailed outcome assessments, but its limitations, such as the relatively small
sample size and short follow-up duration, highlight the need for further
research. Future studies should explore the long-term effects of biologic
therapies on disease progression, joint damage, and the cost-effectiveness of
these treatments in diverse patient populations.
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