Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Participation, in particular work productivity, is increasingly recognized as an important outcome in RA. Here we describe workplace limitations in patients (pts) with RA treated with tofacitinib.

Methods: Data were reviewed from five, Phase 3, double-blind, randomized controlled trials of 6-24 months’ duration in pts with 7-13 years’ mean disease duration, having failed various disease-modifying antirheumatic drugs (DMARDs). Tofacitinib was dosed at 5 or 10 mg twice daily (BID) as either monotherapy (ORAL Solo, NCT00814307) or in combination with non-biologic DMARDs (mainly methotrexate) in pts with inadequate responses to ≥1 non-biologic or biologic DMARD, including tumor necrosis factor inhibitors (ORAL Scan, NCT00847613 [1-year data]; ORAL Sync, NCT00856544; ORAL Standard, NCT00853385; ORAL Step, NCT00960440). The 25-item Work Limitations Questionnaire (WLQ) was used to assess the impact of RA on job performance and productivity. Responses are combined into 4 scales ranging from 0 (no limitation) to 100 (limited all of the time): time management, physical, mental/interpersonal, and output demands.

Results: Proportions of pts working at the baseline visit were: 49% (302/611; ORAL Solo), 50% (394/792; ORAL Sync), 49% (387/797; ORAL Scan), 39% (278/717; ORAL Standard), 38% (153/399; ORAL Step). Least squares mean changes from baseline at Month 3 are presented in the Table.

Conclusion: Across the five Phase 3 studies reviewed, pts receiving tofacitinib reported significant effects in at least one scale of the WLQ, but not across all scales. These pt populations had long disease duration having failed multiple DMARDs, including biologics, and only 38‑50% of pts were working at the baseline visit. Taken together, these data indicate an overall positive effect of tofacitinib on work productivity in pts with RA.

		LSM change from baseline at Month 3
Scale	Treatment	ORAL Solo	ORAL Sync	ORAL Scan	ORAL Standard	ORAL Step
Time Management Demands	Tofacitinib 5 mg BID	11.43	-11.31	-4.01	-9.83	-10.96*
	Tofacitinib 10 mg BID	11.55	-14.58	-9.43	-16.01**	-11.03*
	Placebo	5.67	-8.26	-5.64	-0.52	4.09
Physical Demands	Tofacitinib 5 mg BID	0.99	-5.60**	0.30	-0.10	-0.17
	Tofacitinib 10 mg BID	-3.75	-4.06*	-4.41	-5.84	-2.89
	Placebo	-2.47	6.17	-0.98	3.67	-9.42
Mental/ Interpersonal Demands	Tofacitinib 5 mg BID	5.03	-9.29	-2.94	-3.37	-2.69
	Tofacitinib 10 mg BID	6.18	-9.67	-5.32	-7.99	-5.29*
	Placebo	4.52	-8.15	1.24	-0.48	7.11
Output Demands	Tofacitinib 5 mg BID	9.52	-9.71	-6.15	-8.29	-11.36**
	Tofacitinib 10 mg BID	9.80	-13.10	-11.40**	-13.49*	-8.15*
	Placebo	4.54	-8.89	-0.64	-3.82	6.25
*p<0.05; **p<0.01 versus placebo; no correction for multiple comparisons P-values are for LSM change from baseline versus placebo. Negative values imply improvement BID, twice daily; LSM, least squares mean

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/effects-of-tofacitinib-an-oral-janus-kinase-inhibitor-on-work-limitations-in-patients-with-rheumatoid-arthritis/