Background/Purpose:

Results from randomized controlled trials indicate that about one-third of rheumatoid arthritis (RA) patients initially treated with anti-TNF agents do not respond, show a sub-optimal response, lose response, or develop adverse events (Kwoh et al 2002).  Patients who discontinue their first biologic DMARD therapy might need to switch to a second or subsequent biologic DMARD treatment.  The objective of this analysis is to describe reasons for discontinuation of their first anti-TNF for the treatment of RA and subsequently discontinuing either a second anti-TNF or biologic DMARDs with other mechanisms of action (oMOA).

Methods:

An observational, non-interventional, retrospective chart review study was conducted in 8 centers in the United States from February to September 2012.   Patient charts were eligible if the patient’s first biologic DMARD was a anti-TNF; they were 18 years or older at time of the second DMARD; and they were prescribed the second and/or third biologic DMARD during the period July 1, 2006 and October 1, 2011. The proportion of patients stating each reason for treatment discontinuation are described for patients discontinuing anti-TNF vs. oMOA as their second and/or third biologic DMARD.

Results: 

A total of 176 charts were abstracted for patients who discontinued a anti-TNF as their first biologic DMARD and received a second biologic DMARD.  Second biologic DMARD treatments were another anti-TNF for 122 patients and treatments with oMOA for 54 patients.  At time of chart abstraction 108 patients had discontinued the second DMARD.  Of these, 98 then received a third biologic DMARD (36 anti-TNF and 62 with oMOA) with 43 of these patients discontinuing the third biologic DMARD.  Reasons for discontinuation are shown in the table:

	Reasons for discontinuation of Biologic DMARDs
		Second biologic		Third biologic
	First anti-TNF (n=176)	anti-TNF (n=122)	oMOA (n=54)	anti-TNF (n=36)	oMOA (n=62)
Discontinued, n (%)	176 (100)	87 (71.3)	21 (38.9)	21 (58.3)	22 (35.5)
Reason, n (%)*
Lack of initial efficacy	40 (22.7)	35 (40.2)	4 (19.0)	10 (47.6)	12 (54.5)
Failure to maintain response (disease flare)	82 (46.6)	27 (31.0)	7 (33.3)	2 (9.5)	6 (27.3)
Safety/tolerance	30 (17.0)	18 (20.7)	3 (14.3)	4 (19.0)	1 (4.5)
Patient doing well	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Patient or physician preference	1 (0.6)	0 (0.0)	1 (4.8)	0 (0.0)	0 (0.0)
Cost, insurance, or formulary	13 (7.4)	1 (1.1)	3 (14.3)	1 (4.8)	2 (9.1)
Other or not reported	13 (7.4)	7 (8.0)	3 (14.3)	4 (19.1)	1 (4.5)
*Among those who discontinued

Conclusion:

The most common reasons for discontinuation of the first anti-TNF agent were efficacy related (69.3%). A numerically greater proportion of patients receiving anti-TNF as their second biologic discontinued due to lack of initial efficacy compared with those that received second biologic with other mechanism of action.  In addition, safety/tolerance was a more common reason for discontinuation among those receiving anti-TNF than those receiving treatment with other mechanisms of action.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/reasons-for-discontinuation-of-biologic-agents-in-rheumatoid-arthritis-patients/