Sex-associated Treatment Differences and Their Outcomes in Rheumatoid Arthritis: Results from the METEOR Register

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Table 1.

Baseline characteristics of men and women. Mean (SD) reported unless otherwise specified.

Characteristics	Men, n = 1142 (21%)		Women, n = 4393 (79%)		p
Characteristics	Values	N	Values	N	p
Age at first visit, yrs	52.0 (14.9)	1139	46.9 (13.9)	4371	< 0.001
BMI, kg/m²	27.1 (4.8)	730	27.0 (6.6)	2500	0.647
RF-positive, %	70.6	1104	75.5	4270	0.001
ACPA-positive, %	66.3	656	70.8	2363	< 0.001
Smoking, %		900		3832	< 0.001
Never	62.3		88.5
Previous smoker	14.2		5.2
Current smoker	23.0		6.3
Symptom duration at diagnosis, mos, median (IQR)	10.3 (3.9–23.9)	1142	12.3 (5.9–34.8)	4393	< 0.001
Time to treatment initiation from diagnosis, days	4.3 (14.8)	1142	3.8 (14.0)	4393	0.009
HAQ, 0–3	0.96 (0.69)	897	1.1 (0.68)	3668	< 0.001
DAS	3.5 (1.1)	753	3.7 (1.0)	2689	< 0.001
DAS28	5.5 (1.4)	817	5.8 (1.4)	2933	< 0.001
ESR, mm/h	46.2 (32.2)	1017	57.4 (33.7)	3809	< 0.001
CRP, mg/l, median (IQR)	24 (11–50)	869	21 (9–45)	3391	< 0.001
VAS patient global, 0–100	53.5 (23.0)	896	55.0 (22.0)	3295	0.091
Ritchie articular index, 0–78	8.6 (6.4)	1061	10.2 (6.6)	4075	< 0.001
SJC, 0–44	7.2 (7.4)	1062	6.5 (6.5)	4079	0.027
TJC 28, 0–28	10.9 (8.7)	1129	12.6 (9.3)	4347	< 0.001
SJC 28, 0–28	6.4 (6.2)	1133	5.8 (5.5)	4368	0.021

BMI: body mass index; RF: rheumatoid factor; ACPA: anticitrullinated protein antibodies; IQR: interquartile range; HAQ: Health Assessment Questionnaire; DAS: Disease Activity Score; DAS28: 28-joint DAS; ESR: erythrocyte sedimentation rate; CRP: C-reactive protein; VAS: visual analog scale; SJC: swollen joint count; SJC28: 28-joint SJC; TJC28: 28-joint tender joint count.

Table 2.

Initial treatment of men and women.

Variables	Men, n = 1142		Women, n = 4393
Variables	n (%)	DAS^*, mean (SD)	n (%)	DAS^*, mean (SD)
csDMARD monotherapy	421 (36.9)	3.4 (1.1)	1804 (41.2)	3.6 (1.0)
MTX	248 (58.9)	3.6 (1.2)	983 (54.5)	3.8 (1.0)
SSZ	83 (19.7)	3.2 (1.1)	181 (10.0)	3.3 (0.9)
HCQ	80 (19.0)	2.8 (0.8)	597 (33.1)	3.4 (0.9)
Other	10 (2.4)	–	43 (2.4)	–
GC monotherapy	103 (9.0)	3.3 (0.9)	252 (5.7)	3.3 (0.9)
csDMARD combination therapy	233 (20.4)	3.5 (1.1)	947 (21.6)	3.9 (1.0)
MTX + HCQ	95 (40.8)	3.3 (1.0)	554 (57.9)	3.9 (1.0)
MTX + SSZ	70 (30.0)	3.6 (1.0)	192 (20.1)	3.7 (1.0)
MTX + SSZ + HCQ	40 (17.2)	3.1 (0.7)	122 (12.8)	3.5 (0.9)
SSZ + HCQ	19 (8.2)	3.3 (0.9)	48 (5.0)	3.5 (0.9)
MTX + LEF	5 (2.2)	4.8 (0.7)	24 (2.5)	3.8 (1.2)
Other	4 (1.7)	–	7 (0.7)	–
csDMARD + GC	271 (23.7)	3.7 (1.2)	928 (21.2)	3.6 (1.0)
MTX + GC	226 (83.4)	3.7 (1.1)	705 (76.0)	3.6 (1.0)
HCQ + GC	21 (7.8)	3.8 (1.7)	136 (14.8)	3.6 (0.9)
SSZ + GC	17 (6.3)	3.6 (1.3)	53 (5.7)	3.8 (1.0)
LEF + GC	4 (1.5)	3.8 (1.2)	26 (2.8)	3.4 (1.1)
Other	3 (1.1)	–	8 (0.9)	–
Combination csDMARD + GC	114 (10.0)	3.6 (1.1)	452 (10.3)	3.9 (1.0)
MTX + HCQ + GC	48 (42.1)	3.5 (1.2)	205 (45.4)	3.8 (1.0)
MTX + SSZ + GC	26 (22.8)	3.6 (0.9)	111 (24.6)	3.9 (1.0)
MTX + SSZ + HCQ + GC	20 (17.5)	3.4 (0.8)	74 (16.4)	3.6 (1.0)
SSZ + HCQ + GC	13 (11.4)	3.4 (0.9)	32 (7.1)	3.6 (1.0)
MTX + LEF + GC	4 (3.5)	3.1 (1.2)	9 (2.0)	4.3 (1.1)
Other	3 (2.6)	–	21 (4.6)	–

↵* DAS based on the non-imputed database. csDMARD: conventional synthetic disease-modifying antirheumatic drugs; MTX: methotrexate; SSZ: sulfasalazine; HCQ: hydroxychloroquine; LEF: leflunomide; GC: glucocorticoid; DAS: Disease Activity Score.

Table 3.

Evolution of HAQ and DAS over time in men and women^a.

Variables	HAQ p^b	DAS
Variables	HAQ p^b	Men, ß (95% CI)	Women, ß (95% CI)	p^b
All patients, n		1142	4393
Sex and followup time interaction	0.200	–	–	0.011
Followup time, yrs		−0.69 (−0.75 to −0.62)	−0.58 (−0.62 to −0.55)
csDMARD combination therapy, n		233	947
Sex and followup time interaction	0.706	–	–	0.014
Followup time, yrs		−0.89 (−1.07 to −0.71)	−0.59 (−0.67 to −0.51)
csDMARD monotherapy, n		421	1804
Sex and followup time interaction	0.453	–	–	0.178
GC, n		103	252
Sex and followup time interaction	0.283	–	–	0.462
csDMARD + GC, n		271	928
Sex and followup time interaction	0.419	–	–	0.263
csDMARD combination + GC, n		114	452
Sex and followup time interaction	0.848	–	–	0.931

↵a Results stem from linear multivariable mixed model analyses adjusted for age, RF, ACPA, symptom duration at diagnosis, BMI, smoking, and country. Different models were constructed for all patients and then for treatment subgroups. Regression coefficients represent the units of change in the outcome per unit of time, in this case, per year.
↵b P values are shown only for the interactions between sex and time. In the presence of a statistically significant interaction, results are stratified by sex, and the evolution of DAS over time is shown for men and women separately. HAQ: Health Assessment Questionnaire; DAS: Disease Activity Score; csDMARD: conventional synthetic disease-modifying antirheumatic drugs; GC: glucocorticoids; RF: rheumatoid factor; ACPA: anticitrullinated protein antibodies; BMI: body mass index.