Differences and similarities in clinical and functional responses among patients receiving tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate: a post hoc analysis of data from ORAL Strategy

Table 3 Statistical analysis of CDAI AUC and ACR-N AUC for months 0 − 12

Treatment group					Tofacitinib + MTX vs tofacitinib monotherapy^a				Tofacitinib + MTX vs ADA + MTX^a
Treatment group	N^b	LSM	SE	95% CI	LSM^c	SE	95% CI	P value	LSM^d	SE	95% CI	P value
CDAI AUC^e for months 0 − 12
Tofacitinib monotherapy	319	194.9	7.1	181.0, 208.7
Tofacitinib + MTX	309	180.0	7.0	166.3, 193.7	− 14.9	8.5	− 31.5, 1.7	0.0788	5.4	8.5	− 11.2, 22.1	0.5234
ADA + MTX	312	174.6	7.1	160.7, 188.4	− 20.3	8.4	− 36.8, − 3.8	0.0162*
ACR-N AUC^efor months 0 − 12
Tofacitinib monotherapy	320	318.7	35.3	249.3, 388.1
Tofacitinib + MTX	310	436.8	35.0	368.1, 505.4	118.1	42.6	34.4, 201.7	0.0057**	34.4	42.8	− 49.6, 118.4	0.4214
ADA + MTX	314	402.3	35.4	332.9, 471.8	83.7	42.5	0.3, 167.0	0.0491*

ACR-N, American College of Rheumatology response rate, where ACR is the percentage improvement from baseline in American College of Rheumatology components, and N represents the minimum percentage achieved by each patient; ADA, adalimumab; AUC, area under the curve; CDAI, Clinical Disease Activity Index; CI, confidence interval; LSM, least squares mean; MTX, methotrexate; SE, standard error
*P < 0.05, **P < 0.01, combination treatment vs tofacitinib monotherapy
^aTreatment comparisons were analyzed using analysis of variance at month 12 with fixed effects of treatment and geographic region (North America; Latin America; Eastern Europe, Israel, and South Africa; Western Europe and Turkey; Asia and Australia)
^bNumber of patients with month 12 data for ≥ 1 efficacy endpoint
^cCombination treatment minus tofacitinib monotherapy
^dTofacitinib + MTX minus ADA + MTX
^eCalculated in months

ISSN: 1478-6362