Background/Purpose:

As with all effective drugs, Methotrexate (MTX) comes with a range of side effects. Some such as pneumonitis are severe enough to require the drug to be stopped. Others such as nausea are more about what a patient will tolerate. We were aware that many patients were tolerating side effects in order to take MTX. If the benefits outweigh the problem, then the medical advice would be to continue. This also applies to patients taking methotrexate in combination with TNFis where there is considerable advantage from taking the combination. For this reason there was little interest in exploring methotrexate “tolerability”. However, there is now good evidence that Tocilizumab works as well alone as in combination with Methotrexate. This offers the possibility that some patients struggling with methotrexate may be better off on Tocilizumab monotherapy rather than a TNFi and their MTX. We were interested to quantify the tolerability problems of patients continuing on Methotrexate therapy.

Methods:

100 consecutive patients seen in outpatient clinics, who were taking a stable dose of MTX and planning to continue, were surveyed. A study sheet was completed seeking information on the effectiveness of the MTX, their concordance with treatment and any side effects they were getting. They were specifically asked about: nausea; fatigue; mouth ulcers and hair loss and asked to rate them on a VAS.

68 were female and 32 were male with an average age of 59 (24 – 84 yrs). 89 were on oral and 11 on subcutaneous injections. 75 patients were suffering from RA, 18 patients from psoriatic arthritis with 7 patients having other indications.

Results:

Efficacy averaged 6.5 being similar in men and women (6.7 & 6.4). 56% complained of at least one side effect. The side effects and the judged severity are shown in the table. VAS scores for severity averaged in the range 3.5 to 5. Sex differences were apparent. Men were less likely to complain of problems, in particular hair loss and nausea. Whether this relates to tolerance or intolerance is not clear.  Only 10% “forgot” to take their MTX for an average of 2 weeks in a year. 5 chose not to take an average of 2.6 doses in a year. These patients had higher intensity of side effects (6-9.5)

	Nausea*	Mouth Ulcers	Hair Loss**	Fatigue	Other S/Es	Any Side Effect
WOMEN n=68	4.3 (±2.5) n=22 (32%)	4.3 (±2.9) n=18 (26%)	3.5 (±2.2) n=13 (19%)	5.0 (±1.9) n=17 (25%)	5.5 (±3.4) n=6	4.6 n=43 (63%)
MEN n=32	3.4 (±2.1) n=4 (13%)	2.7 (±2.0) n=9 (28%)	0.0 n=0 (0%)	4.3 (±0.8) n=3 (9%)	2.8 (±0.6) n=3	2.8 n=13 (41%)
TOTALS	n=26	n=27	n=13	n=20	n=9	n=56

Chi Test x²

*p<0.05 **p<0.01

Conclusion:

 Patients are putting up with a lot of side effects, which are outweighed by the benefits of MTX for them. When a biologic is necessary to control their disease, some patients may be attracted by one that does not require combination with MTX.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/what-do-patients-put-up-with-for-the-benefit-they-get-from-methotrexate/