Clinical Characteristics and Treatment Outcomes of Early Axial Spondyloarthritis Patients in India: A Multicentric Prospective Observational Study

Abstract

Background:

This multicentre prospective observational study assessed the clinical characteristics, treatment modalities and short-term outcomes of patients diagnosed with early axial spondyloarthritis (axSpA) in India.

Methods:

Fourteen rheumatology outpatient clinics in India enrolled patients aged ≥18 years with axial symptoms of <2 years who met the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axSpA. Disease activity indices (Ankylosing Spondylitis Disease Activity Score [ASDAS] and Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]), functional index (Bath Ankylosing Spondylitis Functional Index [BASFI]), non-steroidal anti-inflammatory drug (NSAID) intake scores, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were assessed at baseline, 3 months and 6 months. Correlation analysis was conducted between the study results and comparable international early axSpA inception cohorts.

Results:

A total of 155 patients (81% men, mean age 28 years) were included in the study. Eighty-five percent of patients were human leukocyte antigen B27 (HLA-B27) positive. Peripheral arthritis (31%), enthesitis (32%) and uveitis (14%) were common. At baseline, the mean (standard deviation (SD), 95% confidence interval) of the ASDAS-CRP, BASDAI and BASFI indices was 3.5 (1.1, 3.3–3.7), 4.2 (1.7, 3.9–4.5) and 3.8 (1.8, 3.5–4.2), respectively. After 6 months, these indices decreased to 1.7 (0.8, 1.5–1.8; P < .01), 2.0 (1.5, 1.7–2.2; P < .01) and 1.6 (1.2, 1.3–1.8; P < .01), respectively. The median NSAID intake score decreased from 50 to 10 (P < .01). Radiographic sacroiliitis was observed in 54% of patients and magnetic resonance imaging (MRI) sacroiliitis was observed in 97% of patients.

Conclusion:

This study demonstrates that early diagnosis and treatment of axSpA significantly improved clinical outcomes and reduced NSAID use in the study participants. The genetic and clinical profiles of Indian patients with early axSpA are comparable to those of patients worldwide. The high radiographic sacroiliitis observed in this study suggests a delayed diagnosis of axSpA in Indian patients.

Keywords

Early axial spondyloarthritis (axSpA)India MRI sacroiliitis non-steroidal anti-inflammatory drug (NSAID) score disease activity indices

Introduction

Axial spondyloarthritis (axSpA) is a chronic immune-mediated inflammatory condition that predominantly affects the sacroiliac joints and spine. AxSpA manifestations typically encompass inflammatory back pain (IBP), enthesitis and peripheral arthritis. AxSpA is frequently associated with extra-musculoskeletal manifestations (EMMs), such as uveitis, psoriasis and inflammatory bowel disease (IBD).¹ In India, the estimated prevalence of spondyloarthritis is approximately 0.2%–0.3%.² Approximately 5%–10% of patients with early axSpA exhibiting positive magnetic resonance imaging (MRI) findings may develop radiographic sacroiliitis within 2 years and this percentage may escalate to approximately 30% within the subsequent 10 years of disease follow-up.³

In recent years, the relative ease of access to MRI has facilitated the early diagnosis of axSpA in appropriate clinical settings. The Assessment of SpondyloArthritis International Society (ASAS) has recently defined early axSpA as a disease characterised by axial symptoms that persist for less than 2 years. Axial symptoms include back or buttock pain or morning stiffness and are typically attributed to axSpA by rheumatologists.⁴ Studies have demonstrated that early detection and treatment initiation of axSpA significantly improve patient outcomes, prevent further deformities and reduce healthcare expenses.⁵ In numerous cases, the administration of non-steroidal anti-inflammatory drugs (NSAIDs) alone results in substantial pain relief, reduced functional impairment and disease remission.⁶ However, in real-world clinical practice, the diagnosis of axSpA is frequently delayed due to various factors, particularly in resource-constrained nations such as India.⁷ Consequently, there is a scarcity of real-world data pertaining to early axSpA diagnosis and management in low- and middle-income countries, such as India.

Therefore, we endeavoured to investigate early axSpA in the regional Indian population within an outpatient clinic setting. The primary objectives of the present study were to elucidate the characteristics of early axSpA in Indian patients, ascertain the treatment modalities employed by Indian rheumatologists for early axSpA patients and evaluate the short-term (at 3 and 6 months) outcomes in terms of disease activity and NSAID intake scores. Additionally, we conducted a comparability assessment of our study cohort with previously published international cohorts.

Methods

Fourteen rheumatology centres in India participated in this prospective observational study. The study investigators were members of the Spondyloarthropathy Special Interest Group of the Indian Rheumatology Association.

Study Design

Patients aged ≥ 18 years who met the 2009 ASAS classification criteria for axSpA and had axSpA symptoms for less than 2 years were recruited for the study. Patients were recruited from the outpatient clinics of participating rheumatology centres. Patients with a history of axSpA diagnosis who were on treatment with disease-modifying anti-inflammatory drugs (DMARDs), juvenile-onset spondyloarthritis, peripheral spondyloarthritis or pregnancy were excluded from the study (Figure 1).

Figure 1.

Study Protocol Flow Diagram.

Data were collected over a 6-month period (baseline, 3 months and 6 months) from July 1, 2022, to January 31, 2023. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), human leukocyte antigen B27 (HLA-B27), pelvic radiographs and magnetic resonance images of the sacroiliac joints were recorded at baseline. The images were reported by local radiologists, who were not part of the study investigators. The 2022 ASAS-European Alliance of Associations for Rheumatology (EULAR) management guidelines⁸ were followed throughout the study. At the 3- and 6-month follow-up appointments, the treating rheumatologist adjusted the pharmacological management plan to achieve low disease activity, defined as Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of <2.1 and <4, respectively. The ASAS-NSAID score calculator⁹ was used to calculate NSAID intake. During each clinic visit, NSAID scores, ASDAS ESR, ASDAS-CRP, BASDAI and Bath Ankylosing Spondylitis Functional Index (BASFI) were measured. Written informed consent was obtained from all participating patients. All patient records were anonymised. The study was conducted in accordance with the Declaration of Helsinki and ethics committee approval from the lead institution was obtained from the Ethics Committee for Research, Fortis Flt. Lt. Rajan Dhall Hospital (ECR Reference No. ECR/2022/TH/03, May 31, 2022) was subsequently approved by the respective ethics committees at the study centres.

Statistical Analysis

For the analysis of continuous variables, the mean ± standard deviation (SD) and median with interquartile range (IQR) were used. Categorical variables were summarised by providing frequencies and percentages. For group comparisons of continuous variables, parametric (t–tests) and non-parametric (Mann-Whitney U) tests were used, whereas for categorical variables, chi-square and Fisher’s exact tests were applied as necessary.

To assess temporal changes in key outcome variables, a repeated-measures analysis of variance (ANOVA) was conducted, with a specific focus on disease activity scores (ASDAS and BASDAI), functional scores (BASFI) and NSAID scores across three time points: baseline, 3 months and 6 months. Pearson (r) or Spearman (ρ) coefficients were used for correlation analysis among variables. Individual category assessments were performed to ensure that missing data did not adversely affect the results. Multiple comparisons across subgroup analyses were performed without formal adjustment, as these analyses were exploratory and intended to identify trends rather than confirm statistical hypotheses. For repeated-measures ANOVA, only participants with complete data available at all three time points (baseline, 3 and 6 months) were included in the analysis. No specific missing data imputation methods were applied, as repeated-measures ANOVA requires complete cases for within-subject comparisons. Consequently, analyses were conducted using a complete-case approach. Statistical significance was set at P < .05. Statistical analyses were performed using SPSS (version 29).

Results

A total of 155 patients were included in the study, of whom 125 (80.6%) were men. The mean age of the study cohort was 28 ± 8.7 years, with a range of 18–62 years. The age distributions were 44.5% ≤ 25 years, 38.7% 26–35 years and 16.8% > 35 years. The median disease duration (IQR) was 12 months (8–12) (Table 1).

Overall, HLA B27 n (%) positivity was observed in 133 (85.8%) patients. The prevalence rates of HLA B27 positivity in men and women were 108 (85.7%) and 25 (86.2%), respectively. Approximately 48 (31%) and 50 (32%) patients had peripheral arthritis and enthesitis, respectively. Uveitis was the most common EMM, present in 21 (14%) patients, followed by psoriasis in 3 (2%) and IBD in 2 (1%). The median (IQR) baseline CRP level was 10 mg/L (3–24). Approximately one-fourth of the study participants experienced hip pain within 2 years of diagnosis (Table 1).

Table 1.

Clinical, Demographic and Investigation Profile of the Study Patients.

Demography n = 155
Age in years, mean (SD)	28 (8.7)
Gender n (%)	Male 125 (80.6) Female 30 (19.4)
Disease duration in months, median (IQR)	12 (8–20)
Family history of spondyloarthritis n (%)	36 (23)
Clinical features n = 155
Peripheral arthritis n (%)	48 (31)
Hip tenderness n (%)	45 (29)
Enthesitis n (%)	50 (32)
Extra-musculoskeletal manifestations n = 155
Psoriasis n (%)	3 (2)
IBD n (%)	2 (1)
Uveitis n (%)	21 (14)
Blood investigations, n = 155
HLA B27 positive n (%)	133 (85.8)
CRP (mg/L), median (IQR)	Baseline: 10.0 (3–24) 3 months: 4.0 (2–10) 6 months: 2.6 (1.35–6)
ESR (mm), median (IQR)	Baseline: 34 (20–50) 3 months: 20 (12–30) 6 months: 15 (10–22)
Radiology investigations n (%)
Radiographic sacroiliitis (n = 155)	84 (54)
MRI sacroiliitis (n = 123)	119 (97)

At baseline, the mean (SD, 95% confidence interval) of ASDAS-CRP, BASDAI and BASFI indices were 3.5 (1.1, 3.3–3.7), 4.2 (1.7, 3.9–4.5) and 3.8 (1.8, 3.5–4.2), respectively. After 6 months, these indices decreased to 1.7 (0.8, 1.5–1.8), 2.0 (1.5, 1.7–2.2) and 1.6 (1.2, 1.3–1.8), respectively (Table 2). The reduction in disease activity was statistically significant (P < .05) for all comparisons. All patients (n = 155) underwent pelvic radiography and 123 (79.3%) underwent MRI of the sacroiliac joints. MRI was not performed in all patients due to cost and logistical constraints. Approximately 84 (54.1%) patients had radiographic evidence of sacroiliitis. MRI findings of sacroiliitis were observed in 119 patients (97%).

Table 2.

Disease Activity Measures.

Disease Activity Measures, n = 155
	Baseline	3 Months	6 Months	P Value
ASDAS-CRP, mean (SD, 95% CI)	3.5 (1.1, 3.5–3.7)	2.2 (1, 2.0–2.3)	1.7 (0.8, 1.5–1.8)	<.05
BASDAI, mean (SD, 95% CI)	4.2 (1.7, 3.9–4.5)	2.4 (1.5, 2.1–2.7)	2 (1.5, 1.7–2.2)	<.05
BASFI, mean (SD, 95% CI)	3.8 (1.8, 3.5–4.2)	2 (1.4, 1.7–2.2)	1.6 (1.2, 1.3–1.8)	<.05

As an initial treatment strategy, NSAIDs were administered to all patients unless contraindicated. The median (IQR) baseline NSAID score was 50 (25–80), which decreased to 10 (0–25) at the end of 6 months (Figure 2). This change was statistically significant (P < .01). The most frequently used drug combination was NSAIDs plus sulfasalazine (SSZ) (39%) (Table 3). The combination of NSAIDs, a tumour necrosis factor inhibitor (TNFi) and SSZ was the second most preferred combination, initiated in 29.6% of patients. Tofacitinib therapy in conjunction with NSAIDs was initiated in 8.4% of the patients. During the study period, transaminitis occurred in one patient on a combination of regular NSAIDs and tofacitinib and in two patients on SSZ, necessitating modifications in therapy. All prescribed medications were generally well tolerated throughout the study period and no significant safety concerns were observed. However, one patient developed an allergic reaction to secukinumab and another experienced cerebral venous thrombosis while receiving tofacitinib.

Figure 2.

Note: Baseline NSAID consumption score median (IQR), was 50 (25–80); at 3 months, 17 (1–50); and at 6 months, 10 (0–25).

Table 3.

Initial Therapy.

Initial Therapy n = 155, n (%)
NSAIDs + SSZ	60 (39%)
NSAIDs + TNFi+SSZ	46 (29.6%)
NSAIDs + TOF	13 (8.4%)
NSAIDs only (regular)	12 (8%)
NSAIDs only (intermittent)	8 (5%)
NSAIDs + MTX + SSZ	6 (4%)
NSAIDs + TOF + SSZ	5 (3%)
NSAIDs + MTX	2 (1.2%)
NSAIDs + LFN	2 (1.2%)
NSAIDs + IL-17i	1 (0.6%)

Note: NSAID = Non-steroidal anti-inflammatory drug; TNFi = Tumour necrosis factor inhibitor; MTX = Methotrexate; SSZ = Sulfasalazine; TOF = Tofacitinib; LFN = Leflunomide; IL-17i = Interleukin 17 inhibitor.

Correlation Analysis and Variable Relationships

Age

In the study cohort, age distribution was comparable between groups; HLA B27 positive: 27.82 ± 8.30 years vs. HLA B27 negative: 29.82 ± 10.90 years (P = .320). Age group analysis revealed similar disease activity index values across age categories. Patients ≤25 years, 26–35 years and >35 years of age showed similar ASDAS (3.54 vs. 3.56 vs. 3.55, P = .993), BASDAI (4.02 vs. 4.26 vs. 3.97, P = .664) and BASFI scores (3.88 vs. 3.85 vs. 3.59, P = .791) (Figure 3).

Figure 3.

Note: Disease activity measures (ASDAS, BASDAI and BASFI) remain consistent across age groups, indicating uniform disease severity at baseline, regardless of age at presentation (error bars showing standard deviations).

In this study, age emerged as an important factor in determining the imaging strategy. In younger patients (≤25 years), radiographic sacroiliitis negativity was prevalent (56.5%), despite the probable presence of inflammation discernible via MRI. Conversely, radiographic alterations were more common in older patients (>25 years) (62.8%), indicating accumulated structural damage (Supplementary Table 1).

Sex

Sex differences were minimal in this cohort (Supplementary Table 1). While the sample showed the expected male predominance (80.6% male vs. 18.7% female), age differences in sex approached but did not reach significance (males: 27.60 ± 8.56 vs. females: 30.28 ± 9.14 years, P = .137). Baseline disease activity indices showed no significant sex-based differences: ASDAS (3.59 vs. 3.34, P = .285), BASDAI (4.12 vs. 4.01, P = .738), BASFI (3.92 vs. 3.39, P = .180) and NSAID score (52.27 vs. 51.82, P = .948). The effect sizes for sex differences were small (Cohen’s d range: −0.31–0.28).

HLA B27

HLA B27 status showed no relationship with sex (chi-square = 0.000, P = 1.000) or disease activity indices (chi-square = 0.956, P = .812), confirming that genetic and demographic factors operate independently of clinical severity.

Disease Activity Indices for axSpA

The strongest correlation was observed between the ASDAS and BASDAI (r = 0.645, P < .001), indicating that these two disease activity measures capture similar underlying disease processes. Functional impairment was significantly correlated with disease activity, as demonstrated by the strong correlations between ASDAS and BASFI (r = 0.582, P < .001) and between the BASDAI and BASFI (r = 0.565, P < .001).

NSAID Scores

The intensity of NSAID intake correlated with disease activity measures. Significant positive correlations were observed between NSAID usage and disease activity scores: BASDAI-NSAID (r = 0.404, P < .001), ASDAS-NSAID (r = 0.338, P < .001) and BASFI-NSAID (r = 0.315, P < .001).

Extra-musculoskeletal Manifestations

In our study cohort, uveitis was diagnosed in 21 (14%) patients. Among these patients with uveitis, 18 (85.6%) were HLA-B27 positive. However, upon analysing the entire cohort, uveitis, psoriasis and IBD did not correlate with other study variables, such as HLA-B27, age, sex or disease activity indices.

Imaging

Radiographic sacroiliitis was significantly associated with higher ASDAS-CRP and NSAIDs scores (Table 4).

Table 4.

Comparison of Clinical Disease Activity Measures Between Patients with Positive and Negative Radiographic Sacroiliitis.

Variable	Radiographic Positive n	Radiographic Positive Mean n (SD)	Radiographic Negative n	Radiographic Negative Mean n (SD)	P Value
ASDAS-CRP	84	3.36 (1.13)	71	3.77 (1.1)	.0211
BASDAI	84	4.0 (1.85)	71	4.22 (1.5)	.4415
BASFI	82	3.66 (2.09)	70	4.02 (1.61)	.2413
NSAID score	82	46.84 (34.89)	71	58.37 (30.23)	.0318

Note: Statistical significance P < .05 (significant); NS = Not significant (P ≥ .05).

The relationships between the study clinical variables, age, imaging and HLA B27 are summarised in Supplementary Tables 1 and 2.

Discussion

AxSpA is a heterogeneous systemic rheumatic disease with a variable course.¹ Emerging evidence suggests that early diagnosis and optimal treatment of axSpA may prevent further radiographic progression and improve the quality of life; therefore, early axSpA research is gaining increased attention.^10,11

To the best of our knowledge, this is the first multicentre study in India to comprehensively examine the clinical profile, treatment practices and treatment responses of patients with early axSpA. In our study cohort, 80% of the patients were male, 85.8% had HLA-B27 positivity and approximately 30% had peripheral arthritis and enthesitis. Our study inclusion criteria are similar to two early axSpA inception cohorts from Europe: Spondyloarthritis Caught Early (SPACE) and Devenir des Spondyloarthrites Indifférenciées Récentes (DESIR).^12,13 Our study included patients with a confirmed axSpA diagnosis according to the ASAS criteria, whereas these two cohorts included patients with chronic back pain. The SPACE cohort included adult patients with chronic back pain for <2 years, while the DESIR cohort recruited patients with chronic IBP for <3 years. Our study findings are also similar to those of the early axSpA Swiss Clinical Quality Management (SCQM) registry cohort from Europe.¹⁴ The genetic (HLA B27 positivity) and clinical profiles (axial and articular manifestations) of our study cohort were similar to those of these cohorts (Table 5). Compared to European cohorts, our patients were younger, predominantly male and had higher rates of HLA-B27 positivity. The prevalence of EMMs (uveitis, psoriasis and IBD) in our early axSpA cohort was similar to that in European cohorts. Previous studies have reported that longer disease duration and uncontrolled disease activity are important risk factors for EMMs in patients with axSpA.¹⁵ Our cohort had high baseline mean ASDAS, BASDAI and BASFI scores compared to their European counterparts. These findings may reflect the delayed diagnosis and referral to a rheumatologist in Indian patients.

Table 5.

Clinical Manifestations Comparisons Between Our Study and Similar Early axSpA Inception Cohorts.

Variables	Indian Early axSpA Cohort (Our Study) n (%)	SPACE COHORT¹¹ n (%)	DESIR Cohort¹² n (%)	SCQM Cohort¹³ n (%)
Patients with confirmed axSpA with ASAS criteria	155	60	486	658
Age of inclusion, mean (SD) years	28 (8.7)	29.7 (8.7)	33 (8.6)	38.0 (12.5)
Duration of back pain	<2 years (inflammatory)	<2years (Chronic back pain)	<3 years (inflammatory)	<2 years (inflammatory)
Male gender n (%)	125 (80.6)	29 (48.3)	244 (50.2)	334 (50.8)
HLA B27 positivity n (%)	133 (85.8%)	47 (79.7)	406 (83.5)	353 (59.5)
Family history of SpA n (%)	36 (23)	31 (51.7)	117 (24.1)	110 (19)
Peripheral arthritis n (%)	48 (31)	8 (13.3)	267 (54.9)	252 (38.4)
Uveitis n (%)	21 (14)	9 (15)	60 (8.5)	46 (8.8)
Enthesitis n (%)	50 (32)	8 (13.3)	227 (46.7)	421(64.2)
Psoriasis n (%)	3 (2)	8 (13.3)	112 (15.8)	54 (10.8)
IBD n (%)	2 (1)	3 (5)	23 (4.7)	46 (9.6)
CRP (mg/L), mean (SD)	20.5 (31)	8.4 (11.9)	NA	5 (1.5–10) Median (IQR)
ESR (mm), mean (SD)	37.7 (26)	14.4 (16.7)	NA	NA
Radiographic sacroiliitis n (%)	84 (54)	11(18.3)	187 (38.8)	121(18.9)
MRI sacroiliitis, n (%)	119 (97)	25(41.7)	231 (33.3)	368 (57.7)
ASDAS-CRP, mean (SD)	3.5 (1.1)	2.4 (0.8)	NA	2.8 (1.0)
BASDAI, mean (SD)	4.1 (1.7)	3.9 (2.3)	NA	4.6 (2.2)
BASFI, mean (SD)	3.8 (1.8)	2.7(2.1)	NA	2.9 (2.5)

Radiographic involvement in patients with axSpA is influenced by numerous unfavourable prognostic factors, including elevated CRP levels, male sex, HLA-B27 positivity and prolonged disease duration.¹ Previous research has indicated that radiographic manifestations typically emerge after 3–5 years of uncontrolled disease activity; however, a significant proportion of patients do not develop radiographic changes despite prolonged disease progression.¹⁶ Conversely, at the time of diagnosis, many patients exhibit radiographic evidence of sacroiliac joint damage without any substantial prior spondyloarthritis symptoms.¹⁷ In our study, radiographic sacroiliitis was identified in 54% of patients at diagnosis, which was higher than the 15%–20% reported in other early axSpA cohorts.^12–14 This suggests a delayed diagnosis, potentially attributed to the limited awareness of axSpA among primary care providers and non-rheumatology specialists, as well as the widespread adoption of alternative therapies in India. Sociocultural factors and financial constraints are also potential reasons for delayed specialist referral in India.¹⁸ The high radiographic sacroiliitis in our study cohort may also reflect recall bias due to inaccurate reporting of symptom onset by the study participants.

In our study, patients exhibited a higher prevalence of sacroiliitis than their European counterparts. This observation may indicate a selection bias in our study, as MRI positivity may have given more confidence to the treating rheumatologist for diagnosis. The relatively low utilisation of the clinical arm of the ASAS axSpA classification criteria for patient inclusion might also be a contributing factor to the elevated MRI positivity observed in our study. Notably, hip involvement was observed in one-fourth of the study cohort, which is atypical for early axSpA patients. This finding suggests either rapid disease progression or diagnostic delay. Although the radiographic criteria for hip arthritis were not standardised in this study, this observation warrants further investigation, as hip involvement has traditionally been regarded as a late manifestation of the disease.¹⁹ The possible hypothesis of an inherently higher rate of radiographic progression during the early phase of the disease warrants confirmation through future genotypic and phenotypic analyses in Indian early axSpA patients.

In our study, NSAIDs were universally prescribed at baseline, with the most common combination being NSAIDs and SSZ, followed by triple therapy including TNFis. Approximately 80% of our patients were taking NSAIDs regularly or intermittently, similar to the patients in the SPACE cohort. Although SSZ has limited evidence of benefit in axial disease, its continued use in India is supported by regional studies.^20,21 In the SPACE cohort, 8.3% of patients were on DMARDs, while in the SCQM cohort, 11.2% of patients were on DMARDs. The substantial prevalence of DMARDs (61.38%) in our cohort, in contrast to the SPACE and SCQM cohorts, may be attributed to the higher incidence of peripheral arthritis (31%) compared with the SPACE (8.33%) and SCQM (11.2%) cohorts. Furthermore, the persistent practice of Indian rheumatologists to prescribe DMARDs, predominantly SSZ, for axial symptoms may contribute to this disparity.^20,21 In our study, approximately 30% (TNFi) and 0.6% interleukin 17 inhibitor (IL-17i) of the patients were prescribed biologics. The biological usage in our cohort was more in line with that of the SCQM cohort, where the TNFi and IL-17i prescription rates were 24.8% and 0.6%, respectively. In our cohort, tofacitinib, an oral Janus kinase inhibitor, was used in approximately 13% of patients. Since the completion of data collection, tofacitinib biosimilars have gained widespread availability in India and have become the preferred second-line treatment option before biological therapy. This is likely attributed to its oral administration, cost-effectiveness and acceptable safety profile in younger patients.²²

Over a 6-month period, our study demonstrated substantial decreases in disease activity (ASDAS and BASDAI), functional impairment (BASFI) and NSAID consumption. These findings corroborate those reported in the Swiss SCQM cohort,¹⁴ underscoring the efficacy of early intervention in achieving substantial improvements in patient-reported and disease activity outcomes. Nevertheless, the outcomes of extended studies do not indicate uniform trends in the long-term advantages of early axSpA management.^10,11 More appropriately designed multicentre studies are required to corroborate these findings.

The primary strengths of our study were its real-life multicentre design, low dropout rate and adequate drug compliance. However, a significant limitation of our study is the absence of a centralised analysis of the radiographs and MRI data of the study population. This may have resulted in heterogeneity in the image reporting and reporting bias. In India, accessing patient investigation data is challenging because of the absence of a centralised electronic medical record system, which presents significant obstacles to conducting multicentre research. Other limitations of our study include a relatively small sample size, the absence of a control group and the lack of a follow-up after 6 months, which may prevent causal inference from the conclusions. The study centres followed the 2022 ASAS-EULAR management guidelines and the investigators modified the treatment plan according to the patient’s status at follow-up. This variability in the treatment approach reflects real-world practice patterns across India and enhances external validity, although it limits comparability.

Overall, our study demonstrated that Indian patients with early axSpA exhibit comparable genetic, demographic and clinical manifestation profiles to those of other international early axSpA patient cohorts. Disease activity indices are correlated with NSAID use. Disease activity and functional impairment are closely interrelated, whereas age, sex and HLA-B27 status have minimal impact on disease severity. Notably, there were no significant sex differences in HLA-B27 positivity, disease severity or functional impairment among Indian patients with axSpA, indicating similar disease severity across both sexes. These findings indicate that management protocols should be uniform across both sexes in patients diagnosed with axSpA.

Conclusion

Our study demonstrated that early diagnosis and optimal treatment of Indian patients with axSpA resulted in a substantial reduction in disease activity scores and NSAID use among the study participants. The genetic and clinical profiles of study patients with early axSpA were comparable to those of international early axSpA cohorts. The high prevalence of radiographic sacroiliitis in the study cohort indicates a delayed diagnosis. These findings underscore the necessity of earlier referral pathways and can serve as guiding principles for future multicentre studies conducted in India.

Supplemental Material

Supplemental material for this article is available online.

Footnotes

Acknowledgements

The authors thank Mr Mayur Shinde, statistician at Bhaikaka University, Karamsad, India, for help with the statistical analysis.

Authors’ Contribution

Ashok Kumar: Conception and design of the study.

Himanshu Pathak and Ashok Kumar: First manuscript of draft.

All authors: Data collection, critical revision and final approval of the published version

All authors assume full responsibility for the integrity and accuracy of all aspects of this study.

Declaration of Conflicting Interests

“The preliminary results of this study were presented as a poster at the National Conference of the Indian Rheumatology Association (IRACON) 2023. Ashok Kumar, Subramanian Nallasivan, Lalit Duggal, Ramnath Misra, Sonal Mehra, Sourabh Malaviya and Ved Chaturvedi are members of the Editorial Board of the journal. They were not involved in the decision making process related to the manuscript. The authors report no other disclosures.”

Ethical Approval

The study was approved by the Ethics Committee for Research, Fortis Flt Lt Rajan Dhall Hospital, New Delhi (ECR Reference No. ECR/2022/TH/03, 31 May 2022), and subsequently approved by the respective ethics committees at all participating study centres.

Funding

The authors received no financial support for the research, authorship and/or publication of this article.

Patient Consent

Written informed consent was obtained from all participants prior to enrolment in the study.

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