The impact of tofacitinib on fatigue, sleep, and health-related quality of life in patients with rheumatoid arthritis: a post hoc analysis of data from Phase 3 trials

Table 2 LS mean change from baseline in PRO domain scores at month 3 across treatment groups^a

Outcome	Tofacitinib 5 mg BID (N = 826)			Tofacitinib 10 mg BID (N = 821)			Adalimumab 40 mg Q2W (N = 199)			Placebo (N = 419)
Outcome	n	LS mean change	SE	n	LS mean change	SE	n	LS mean change	SE	n	LS mean change	SE
MOS-SS domain scores
Sleep adequacy	768	7.56^***†	0.86	773	6.67^**	0.86	187	3.37	1.81	387	1.86	1.19
Awaken short of breath/with headache	768	0.20	0.69	773	−1.76^*	0.69	187	−1.07	1.47	387	0.55	0.96
Sleep disturbance	767	−7.58^*	0.68	772	−8.72^**†	0.68	187	−4.66	1.43	387	−5.25	0.94
Sleep quantity (hours)	771	0.18^*	0.04	771	0.27^**	0.04	186	0.16	0.09	386	0.01	0.06
Snoring	761	−0.65	0.78	771	0.09	0.77	186	0.76	1.64	385	−0.57	1.07
Somnolence	767	−5.25^***	0.62	773	−5.91^***†	0.62	186	−3.03	1.32	387	−0.26	0.86
SF-36 domain scores
Physical functioning	772	4.77^***	0.30	774	6.67^***††	0.30	188	4.44^**	0.64	389	2.16	0.42
Role-physical	773	5.42^***	0.31	775	7.28^***††	0.31	188	5.37^**	0.66	389	2.50	0.43
Bodily pain	772	7.41^***	0.30	775	9.43^***††	0.30	188	7.19^***	0.62	389	3.54	0.41
General health	772	4.73^***	0.26	774	5.59^***	0.26	187	4.55^***	0.65	389	1.65	0.36
Vitality	773	5.77^***	0.31	775	6.65^***†	0.31	188	5.02^**	0.65	389	2.18	0.42
Social functioning	773	5.11^***†	0.33	775	6.31^***††	0.33	188	3.51	0.71	389	2.26	0.46
Role-emotional	772	3.79^**	0.39	774	6.24^***†	0.39	188	4.09^*	0.83	388	1.93	0.54
Mental health	773	3.93^***	0.33	775	5.03^***	0.33	188	3.54^*	0.69	389	1.59	0.45

Data were pooled from Phase 3 ORAL Scan, ORAL Standard, and ORAL Sync study datasets, and are presented for the full analysis set
^aAll treatments were administered in combination with background conventional synthetic disease-modifying antirheumatic drugs
^* p < 0.05, ^** p < 0.01, and ^*** p < 0.001 for tofacitinib and adalimumab vs placebo; ^† p < 0.05 and ^†† p < 0.01 for tofacitinib vs adalimumab
BID, twice daily; LS, least squares; MOS-SS, Medical Outcomes Study Sleep scale; PRO, patient-reported outcome; Q2W, once every 2 weeks; SE, standard error; SF-36, Short Form-36 Health Survey

ISSN: 1478-6362