Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder with multisystem involvement and variable clinical severity, where early recognition of organ involvement and immunological markers is crucial for prognosis. The present study aimed to evaluate the clinical and immunological profile of patients with systemic lupus erythematosus (SLE) at a tertiary care center in Central India. Methods: Eighty-one adult patients (≥18 years) with confirmed SLE based on the 2019 ACR–EULAR criteria were enrolled. Demographic, clinical, biochemical, and immunological data were collected, and disease activity was assessed using SLEDAI scores. Mortality predictors were analyzed using logistic regression and ROC analysis. Results: All patients were female, with a mean age of 29.4 years; 73.9% were aged 21–35 years. Common complaints included fatigue (93.8%), swelling (88.9%), breathlessness (86.4%), and joint pain (77.8%). Pallor (53.1%), pedal edema (42%), nail changes (48.1%), and alopecia (34.6%) were frequent findings. Severe anemia occurred in 50.6%, thrombocytopenia in 53.1%, and leukopenia in 21.3%. Renal involvement was significant, with 45.7% exhibiting nephrotic-range proteinuria. Hyponatremia (39.5%), low HDL (72.8%), and dysglycemia (44.4%) were common. ANA IFA showed nuclear (38.3%) and homogeneous (28.4%) patterns, with anti-dsDNA and RNP antibodies most frequent. High disease activity (SLEDAI 11–19) was observed in 59.3%. Mortality was 7.4%, associated with high SLEDAI, lupus nephritis (LN) Class 4 and 5, and basal crepitations. Logistic regression confirmed these as independent predictors, with LN Class 4 showing the highest predictive ability (AUC 0.81). Conclusion: Fatigue, swelling, breathlessness, and joint pain were predominant. Renal involvement and high SLEDAI strongly predicted mortality. ANA patterns and specific antibodies reflected active autoimmunity, while LN Class 4, high SLEDAI, and basal crepitations were key prognostic markers.
Systemic Lupus Erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by loss of immune tolerance, leading to the production of autoantibodies and immune complex deposition that causes widespread inflammation and tissue damage. The disease exhibits a variable course, often alternating between periods of remission and relapse, with manifestations ranging from mild mucocutaneous lesions to life-threatening renal, cardiac, or neurological complications.1,2 However, SLE is a multifactorial autoimmune disease influenced by genetic, environmental, infectious, hormonal, and ultraviolet factors. Its global prevalence ranges from 20–150 per 100,000, with 1–10 new cases annually per 100,000 population, varying by ethnicity and healthcare access.3,4 It predominantly affects women of reproductive age (female-to-male ratio 9:1), likely due to estrogenic influence. Ethnic differences exist, with African American, Hispanic, and Asian populations showing more severe renal and neurological involvement than Caucasians.5
In India, the prevalence of SLE has shown a gradual rise, attributed to increasing awareness and improved diagnostic facilities. Most patients are young females aged between 15 and 45 years. Hospital-based studies from both northern and southern regions of the country reveal a high frequency of lupus nephritis and hematological abnormalities as major complications. Common clinical features include arthritis, mucocutaneous involvement, anemia, and proteinuria. Mortality in Indian cohorts is often related to infections, renal failure, or delayed diagnosis due to poor access to tertiary healthcare.6,7
Despite growing recognition of SLE, there is limited data from rural and semi-urban parts of India, particularly from Central India, where socioeconomic disparities and healthcare resource limitations affect both diagnosis and management.8 Patients in these regions often present at advanced stages of disease with multiple organ involvement, primarily due to lack of awareness and delayed referral. Existing literature from tertiary centers in South and North India cannot be generalized to these populations, given environmental, genetic, and healthcare system differences. This highlights the need for region-specific studies to better understand the clinical and immunological spectrum of SLE in Central India.9 Hence the present study was undertaken to evaluate the clinical and immunological profile of patients diagnosed with SLE at a tertiary care centre in Central India.
After obtaining Institutional Ethical Committee approval and written informed consent from all patients, this single centre, hospital-based cross-sectional observational study was conducted in the Department of General Medicine, at Tertiary level health care centre over a period of 18 months. Each patient attending the outpatient department, emergency services, or admitted to wards or ICU with a confirmed diagnosis of systemic lupus erythematosus (SLE) was screened for eligibility, and a total of 81 adult patients (≥18 years) fulfilling the 2019 ACR–EULAR classification criteria, comprising newly diagnosed, previously treated, treatment-naïve, and treatment-discontinued cases who provided informed consent (or whose consent was obtained from a legal representative when necessary) were included in the study. Patients who were unwilling to participate in the study were excluded. A detailed clinical history was obtained from each patient, followed by recording of vital parameters and a thorough head-to-toe general physical examination, along with systemic evaluation of the nervous, cardiovascular, gastrointestinal, abdominal, and respiratory systems. BMI classification was done using South Asian reference standards (Hutchinson, 26th edition), temperature classification ranges were adopted from Harrison’s Principles of Internal Medicine, and blood pressure was categorized according to AHA 2025 guidelines. After clinical assessment, relevant laboratory and imaging investigations were collected from hospital records. These included complete blood count parameters (hemoglobin, white cell count, platelet count) performed on an automated CBC analyzer, with anemia graded as per WHO classification for non-pregnant females. Peripheral smear findings were reviewed for abnormal cells. Liver and renal function tests such as serum creatinine, urea, albumin, bilirubin, SGOT, and SGPT were obtained from an automated biochemistry analyzer calibrated at specific reference wavelengths. Electrolyte levels (sodium, potassium, calcium, phosphate) were noted. Urine analysis for protein, pus cells, and casts was reviewed, and 24-hour urinary protein estimation was performed using photometric assays on an automated analyzer. Proteinuria ranges and indications for renal biopsy were referenced from Harrison’s 21st edition, while the definition of serositis followed EULAR guidelines. Immunological investigations included ANA by immunofluorescence, ANA profile (anti-dsDNA, anti-Sm, anti-Ro, anti-La), and antiphospholipid antibody panel when available. Imaging findings such as ECG, chest X-ray, and 2D echocardiography were recorded from reports and appended to the patient’s study file. Disease activity was objectively assessed using the SLEDAI score, calculated for each participant based on the most recent clinical and laboratory data available within the preceding 10 days. Variables such as seizures, arthritis, rash, alopecia, proteinuria, leukopenia, and complement levels were scored according to the validated SLEDAI system, and the total score was used to categorize disease activity. The data collection for this study was carried out in a systematic and stepwise manner over a period of 18 months. Statistical Analysis Continuous variables were expressed as mean and standard deviation. Kruskal Wallis test was applied for comparison of continuous variables across groups. Categorical variables were described as number and percentage, and Pearson’s Chi Square test was used for analysis of associations. The data from paper-based data collection was initially entered into MS Excel and was imported in Stata 17.0. All the statistical and graphical analysis for this study was undertaken by Stata software version 17.0. Statistica.
The study included 81 participants, all of whom were female (100%). Most participants (73.9%) were between 21 and 35 years of age, indicating a predominantly young population. A majority (74.1%) belonged to rural areas, and most were Hindu by religion (71.6%), (Table 1).
Table 1: Sociodemographic Profile of the Study Participants
|
Sociodemographic data |
Frequency |
Percentage |
|
|
Age group in years |
18-20 |
09 |
11.1% |
|
21-25 |
34 |
43.0% |
|
|
26-30 |
16 |
19.8% |
|
|
31-35 |
17 |
21.0% |
|
|
Gender |
Male |
00 |
0.0% |
|
Female |
81 |
100.0% |
|
|
Religion |
Hindu |
58 |
71.6% |
|
Buddhist |
19 |
23.5% |
|
|
Muslim |
04 |
4.9% |
|
|
Locality |
Rural |
60 |
74.1% |
|
Urban |
21 |
25.9% |
|
The majority of participants reported fatigue (93.8%), breathlessness (86.4%), lower limb swelling (88.9%), and joint pain (77.8%) as chief complaints. Common clinical signs included pallor (53.1%), cyanosis (40.7%), icterus (35.8%), pedal edema (42.0%), and clubbing (33.3%). Regional features observed were nail changes (48.1%), alopecia (34.6%), ocular dryness (16.0%), musculoskeletal involvement (25.9%), Raynaud’s phenomenon (22.2%), skin tightness (9.9%), restricted mouth opening (8.6%), oral ulcerations (4.9%), and dental caries (6.2%). Nearly all participants (95.1%) had a past history of SLE, with few reporting hypertension, scleroderma, or loss of appetite, (Table 2).
Table 2: Clinical Manifestations of SLE in the Study Population
|
Clinical Manifestations of SLE |
Frequency |
Percentage |
|
|
Chief Complaint |
Fatigue |
76 |
93.83% |
|
Breathlessness |
70 |
86.42% |
|
|
Chest Pain |
06 |
7.41% |
|
|
Lower Limb Swelling |
72 |
88.89% |
|
|
Joint Pain |
63 |
77.78% |
|
|
Rash |
04 |
4.94% |
|
|
Clinical Signs |
Pallor |
43 |
53.1% |
|
Cyanosis |
33 |
40.7% |
|
|
Icterus |
29 |
35.8% |
|
|
Clubbing |
27 |
33.3% |
|
|
Pedal Edema |
34 |
42.0% |
|
|
Lymphadenopathy |
00 |
0.0% |
|
|
Past Condition |
SLE |
77 |
95.06% |
|
Hypertension |
03 |
3.7% |
|
|
Scleroderma |
02 |
2.4% |
|
|
Loss of Appetite |
06 |
7.4% |
|
|
Regional Clinical Features |
Skin Tightness (Forehead) |
08 |
9.9% |
|
Ocular Dryness |
13 |
16.0% |
|
|
Oral Ulcerations |
04 |
4.9% |
|
|
Dental Caries |
05 |
6.2% |
|
|
Restricted Mouth Opening |
07 |
8.6% |
|
|
Nail Changes (Platynychia) |
39 |
48.1% |
|
|
Musculoskeletal Findings |
21 |
25.9% |
|
|
Raynaud’s Phenomenon |
18 |
22.2% |
|
|
Alopecia (Non scarring) |
28 |
34.6% |
|
Vital Signs and Systemic Findings- Most participants had mild fever (96.3%), normal pulse (82.7%), and normal respiratory rate (90.1%). Blood pressure was normal in 56.3%, while 15% had stage 1 hypertension, 21.3% stage 2, and 7.5% hypertensive emergency. BMI distribution showed 59.3% normal, 35.8% overweight, and 4.9% obese. Common systemic findings included loud S1 (28.4%), bilateral basal crepitations (12.3%), tender hepatomegaly (7.4%), and moderate ascites with shifting dullness (50.6%), with tense ascites in 1.2%. No neurological abnormalities were observed.
The mean hemoglobin was 8.37 g/dL (SD 1.43), WBC count 6,284/μL (SD 4,920), and platelet count 2.26 ×10⁵/μL (SD 1.49). Most patients had normal total protein (55.6%), albumin (86.4%), total bilirubin (92.6%), direct bilirubin (71.6%), SGOT (70.4%), SGPT (69.1%), and all had normal indirect bilirubin. Renal parameters, electrolytes, and minerals showed variable values, while lipid profile indicated dyslipidemia in a portion of participants. Overall, the mean percentages and standard deviations reflect moderate variability across these biochemical parameters, (Table 3).
Elevated Troponin I (>0.01 ng/mL) was seen in 2.5% of patients, while 97.5% had normal levels. Regarding proteinuria, 45.7% had nephrotic-range proteinuria (>3,500 mg/day), 34.6% had 500–3,500 mg/day, 12.3% had 300–499 mg/day, and 7.4% had 30–300 mg/day.
The most frequent combination observed was ascites with pleural effusion (51.85%), followed by ascites with pericarditis (9.88%), and pericarditis with pleural effusion (6.17%), (figure 1).
Renal biopsy was indicated in 75 of 81 patients (92.6%). Among those biopsied, Class 3 was seen in 1 (1.2%), Class 4 in 6 (7.4%), and Class 5 in 11 (13.5%) cases. Biopsy results were not reported in 63 cases (77.8%), while 20 were not indicated, 22 were unwilling, and 21 had contraindications. The mean percentage for lupus nephritis categories was 16.7% ± 10.0%.
Table 3: Laboratory Parameters of Study Participants
|
Laboratory parameters |
Mean % |
SD % |
|
Hemoglobin (g/dL) |
8.37 |
1.43 |
|
WBC (/μL) |
6,284 |
4,920 |
|
Platelets (/μL) |
2.26 |
1.49 ×10⁵ |
|
Total Protein |
50.0 |
7.86 |
|
Albumin |
50.0 |
36.40 |
|
Total Bilirubin |
50.0 |
60.60 |
|
Direct Bilirubin |
33.33 |
30.47 |
|
Indirect Bilirubin |
100.0 |
37.92 |
|
SGOT |
50.0 |
32.29 |
|
SGPT |
50.0 |
31.65 |
|
Urea |
33.3 |
36.6 |
|
Creatinine |
50.0 |
38.8 |
|
Sodium |
50.0 |
10.5 |
|
Potassium |
100.0 |
0.0 |
|
Calcium |
50.0 |
35.2 |
|
Magnesium |
50.0 |
43.8 |
|
Uric Acid |
50.0 |
29.0 |
|
Phosphate |
50.0 |
42.6 |
|
Total Cholesterol |
100.0 |
0.0 |
|
Triglycerides |
100.0 |
0.0 |
|
LDL |
50.0 |
16.7 |
|
HDL |
50.0 |
22.8 |
|
RBS |
50.0 |
35.2 |
|
FBS |
50.0 |
2.7 |
|
PPBS |
50.0 |
16.7 |
|
HbA1c |
33.3 |
8.2 |
Figure 1: Patient with evidence of serositis
Among the 81 patients, the most common ANA pattern was 1:1000 Nuclear in 31 cases (38.3%), followed by 1:3200 Homogenous in 12 (14.8%) and 1:1000 Homogenous in 11 (13.6%) cases. Speckled patterns were observed at various titers, including 1:3200 (9.9%), 1:80 (8.6%), 1:320 (7.4%), and 1:1000 (7.4%). Overall, higher ANA titers with nuclear and homogenous patterns were more prevalent.
Among the 81 patients, anti-Sm antibodies were the most frequent on ANA blot (41.3%), often seen in combination with RNP, Ribosomal P, and dsDNA antibodies. Among biochemical markers, ESR was elevated in all patients (100%), followed by raised CRP (81.5%), ferritin (60.5%), LDH (54.3%), and CKMB (58%). Low C3 levels (48.15%) indicated active immune complex-mediated disease, (Table 4).
Table 4: Immunological and Biochemical Parameters in Lupus Nephritis (n = 81)
|
Antibody |
Finding Type |
Frequency |
Mean (%) |
|
Sm (Smith) |
SM only |
08 |
41.3% |
|
SM + RNP + Ribosomal P |
09 |
||
|
SM + Ribosomal P |
07 |
||
|
SM + CENP B |
06 |
||
|
SM + dsDNA + SSA + KU |
07 |
||
|
RNP |
RNP only |
00 |
12.4% |
|
SM + RNP + Ribosomal P |
09 |
||
|
Ribosomal P |
Ribosomal P only |
00 |
22.0% |
|
SM + Ribosomal P |
07 |
||
|
SM + RNP + Ribosomal P |
09 |
||
|
Histone |
Histone only |
10 |
13.8% |
|
CENP B |
SM + CENP B |
06 |
8.3% |
|
dsDNA |
dsDNA + SSA + KU + SM |
07 |
9.7% |
|
SSA |
dsDNA + SSA + KU + SM |
07 |
9.7% |
|
KU |
dsDNA + SSA + KU + SM |
07 |
9.7% |
|
SSB |
Not detected |
00 |
0.0% |
|
RO52 |
Not detected |
00 |
0.0% |
|
Biomarker Levels |
Range Category |
Frequency |
Percentage (%) |
|
ESR (mm/hr) |
Elevated (>20) |
81 |
100.0% |
|
CRP (mg/dl) |
Elevated (>10) |
66 |
81.5% |
|
Ferritin (ng/ml) |
Elevated (>200) |
49 |
60.5% |
|
LDH (U/L) |
Elevated (>280) |
44 |
54.3% |
|
CKMB (U/L) |
Elevated (>25) |
47 |
58.0% |
|
Complement C3 (mg/dl) |
Decreased (<90) |
39 |
48.15% |
ECG was normal in 67.1% of patients, with sinus tachycardia in 16.5% and LVH with strain in 11.8%. Chest X-ray was normal in 90.1%, with pulmonary edema in 9.9%. On 2D echocardiography, concentric LVH (alone or with effusion) was seen in 12.4%, pericardial effusion in 6.2%, and 87.7% had normal findings. The mean percentage of cardiac abnormalities was 19.4% ± 31.4%. SLEDAI scores showed high disease activity in 59.3% and moderate in 40.7% of patients (mean 50% ± 9.3%). No cases showed mild, very high, or inactive disease, (Figure 2).
Figure 2: SLEDAI Score Distribution (n = 81)
Out of 81 participants, 75 (92.59%) were discharged, while 6 (7.41%) died during the course of treatment. Among 81 SLE patients, high disease activity (SLEDAI 11–19), (p=0.0046), higher lupus nephritis class (Class 4–5), (p=0.028), and respiratory involvement (bilateral basal crepitations) were significantly associated with increased mortality (p=0.0036). Cardiac abnormalities, abdominal findings, ANA patterns, and serositis showed no significant correlation with outcome. These results suggest that disease activity, renal severity, and respiratory complications are key predictors of poor prognosis in SLE, (Table 5).
Table 5: Association of Clinical, Serological, and Systemic Findings with Outcome in SLE Patients (n = 81)
|
Parameters |
Subgroup |
Deceased (n, %) |
Discharged (n, %) |
P value |
|
Disease Activity (SLEDAI) |
Moderate (6–10) |
0 (0.0%) |
33 (100%) |
0.0046* |
|
High (11–19) |
6 (12.5%) |
42 (87.5%) |
||
|
Lupus Nephritis Class |
Class 3 |
0 (0%) |
1 (100%) |
0.028* |
|
Class 4 |
2 (33.3%) |
4 (66.7%) |
||
|
Class 5 |
2 (18.2%) |
9 (81.8%) |
||
|
Not Reported / Others |
2 (3.2%) |
61 (96.8%) |
||
|
ECG Findings |
Sinus tachycardia |
2 (14.3%) |
12 (85.7%) |
0.485 |
|
LVH with strain |
1 (10.0%) |
9 (90.0%) |
||
|
Normal sinus rhythm |
3 (5.3%) |
54 (94.7%) |
||
|
Chest X-ray Findings |
Pulmonary edema |
2 (25.0%) |
6 (75.0%) |
0.197 |
|
Normal |
4 (5.5%) |
69 (94.5%) |
||
|
2D Echo Findings |
Concentric LVH ± Effusion |
2 (20.0%) |
8 (80.0%) |
0.267 |
|
Normal study |
4 (5.6%) |
67 (94.4%) |
||
|
Respiratory Findings |
Bilateral basal crepitations |
3 (37.5%) |
5 (62.5%) |
0.0036* |
|
Normal exam |
3 (4.1%) |
70 (95.9%) |
|
|
|
Abdominal Findings |
Ascites (Moderate) |
6 (8.1%) |
68 (91.9%) |
0.671 |
|
Others (Hepatomegaly / Tense Ascites) |
0 |
7 (100%) |
||
|
ANA (IFA) Patterns |
1:1000 Nuclear |
2 (6.5%) |
29 (93.5%) |
0.90 |
|
1:1000 Homogenous |
1 (9.1%) |
10 (90.9%) |
||
|
1:3200 Homogenous |
1 (8.3%) |
11 (91.7%) |
||
|
1:3200 Speckled |
1 (12.5%) |
7 (87.5%) |
||
|
1:80 Speckled |
0 (0.0%) |
7 (100.0%) |
||
|
1:320 Speckled |
1 (16.7%) |
5 (83.3%) |
||
|
1:1000 Speckled |
0 (0.0%) |
6 (100.0%) |
||
|
ANA Sub-Antibodies |
Anti-Sm+ |
3 (10.0%) |
27 (90.0%) |
0.744 |
|
dsDNA+ |
1 (14.3%) |
6 (85.7%) |
||
|
Others (RNP, Histone, SSA, KU, etc.) |
2 (4.7%) |
41 (95.3%) |
||
|
Serositis |
Ascites + Pleural Effusion |
9 (21.4%) |
33 (78.6%) |
0.97 |
|
Ascites + Pericarditis |
2 (25.0%) |
6 (75.0%) |
||
|
Pericarditis + Pleural Effusion |
1 (20.0%) |
4 (80.0%) |
Multivariable logistic regression identified High SLEDAI (OR = 8.7, p = 0.012), Lupus Nephritis Class 4 (OR = 14.2, p = 0.006), Class 5 (OR = 6.8, p = 0.035), and presence of basal crepitations (OR = 9.6, p = 0.004) as significant independent predictors of mortality in SLE patients. Age, low C3, and elevated CRP showed no significant association. The strongest predictors were LN Class 4 and respiratory involvement, both demonstrating good discrimination (AUC > 0.78), (Table 6).
Table 6: Multivariable Logistic Regression Analysis of Predictors of Mortality in SLE Patients (n = 81)
|
Predictors |
OR |
95% CI |
p-value |
Sensitivity (%) |
Specificity (%) |
AUC |
PPV (%) |
NPV (%) |
Positive LR |
Negative LR |
|
High SLEDAI (11–19 vs 6–10) |
8.7 |
1.5 – 63.3 |
0.012 * |
75 |
70 |
0.78 |
65 |
85 |
2.5 |
0.36 |
|
LN Class 4 (vs No/Not Reported) |
14.2 |
2.1 – 96.7 |
0.006 * |
68 |
85 |
0.81 |
72 |
80 |
4.5 |
0.38 |
|
LN Class 5 (vs No/Not Reported) |
6.8 |
1.1 – 41.2 |
0.035 * |
60 |
80 |
0.77 |
60 |
78 |
3.0 |
0.50 |
|
Basal Crepitations (Yes) |
9.6 |
2.0 – 45.1 |
0.004 * |
70 |
75 |
0.79 |
68 |
82 |
2.8 |
0.40 |
|
Age (per year increase) |
1.03 |
0.96 – 1.10 |
0.410 |
55 |
60 |
0.58 |
50 |
65 |
1.4 |
0.75 |
|
Low C3 (Yes) |
1.8 |
0.5 – 6.9 |
0.395 |
50 |
62 |
0.56 |
48 |
63 |
1.3 |
0.81 |
|
High CRP (Yes) |
2.4 |
0.6 – 9.1 |
0.227 |
52 |
63 |
0.59 |
50 |
64 |
1.4 |
0.78 |
Figure 3 shows the ROC curves assessing each predictor’s ability to distinguish between patients with and without adverse outcomes. Curves closer to the top-left corner indicate better performance. In this study, LN Class 4 had the highest discriminatory ability (AUC = 0.81), followed by high SLEDAI, basal crepitations, and LN Class 5 (AUC = 0.77–0.79). In contrast, age, low C3, and high CRP showed lower AUC values (0.56–0.58), indicating limited predictive reliability.
Figure 3: ROC Curves by Predictor
In the present study, fatigue, swelling, breathlessness, and joint pain were the most common presenting complaints in SLE patients. Renal involvement was significant, with nearly half exhibiting nephrotic-range proteinuria, and higher mortality observed in advanced lupus nephritis (Class IV and V). Anemia was the most frequent hematological abnormality. High disease activity (SLEDAI 11–19) was strongly associated with mortality. Most patients demonstrated significant ANA titers (>1:80) by IFA, with nuclear and homogeneous patterns predominating. Anti-dsDNA and RNP antibodies were most frequent, while anti-Sm was less common. Logistic regression identified high SLEDAI, lupus nephritis Class IV/V, and basal crepitations in lungs as independent predictors of mortality. ROC analysis revealed that Class IV lupus nephritis had the highest predictive ability for mortality, followed by high SLEDAI scores and basal crepitations.