How should a patient on Simponi Aria (golimumab) infusions be transitioned to Otezla (apremilast) 30 mg twice a day?

Transitioning from Simponi Aria to Otezla

Stop Simponi Aria (golimumab) infusions immediately without any washout period or tapering, and begin Otezla (apremilast) using the mandatory 5-day dose titration schedule starting the same day or within days of the last infusion. There is no evidence requiring a washout period between these medications, and delaying treatment unnecessarily prolongs the time without adequate disease control.

Discontinuation of Simponi Aria

• Simply stop the infusions—no tapering or gradual dose reduction is required for golimumab. 1
• Biologic agents like golimumab do not require tapering when discontinuing, unlike some other systemic therapies 1
• The half-life of golimumab will result in gradual clearance from the system over subsequent weeks, but this does not necessitate a waiting period before starting apremilast

Initiating Otezla (Apremilast)

• Begin apremilast using the mandatory 5-day titration schedule to minimize gastrointestinal side effects 1, 2:

  • Day 1: 10 mg AM only
  • Day 2: 10 mg AM and 10 mg PM
  • Day 3: 10 mg AM and 20 mg PM
  • Day 4: 20 mg AM and 20 mg PM
  • Day 5: 20 mg AM and 30 mg PM
  • Day 6 onward: 30 mg AM and 30 mg PM (maintenance dose)

• Do not crush, split, or chew the tablets 2

• Apremilast can be taken without regard to meals 2

Special Dosing Considerations

• If the patient has severe renal impairment (creatinine clearance <30 mL/min), reduce the maintenance dose to 30 mg once daily and use only the AM titration schedule, skipping all PM doses 1, 2
• No dose adjustment is needed for hepatic impairment 3

Critical Monitoring During Transition

• Counsel the patient before starting apremilast about the risk of gastrointestinal side effects (diarrhea, nausea), which occur in 70-80% of patients within the first 2 weeks, are typically mild, and resolve in 60-65% within the first month 1
• Discuss the risk of depression (approximately 1% of patients) and monitor for emergence or worsening of depressive symptoms 1, 2
• Monitor body weight regularly at each visit—if weight loss exceeds 5% from baseline, consider discontinuing apremilast 1, 3
• Elderly patients are at higher risk for dehydration from GI effects and may require hospitalization, so monitor these patients more closely 1, 2

Laboratory Monitoring

• No routine laboratory monitoring is required for apremilast, which is a major advantage over many other systemic therapies 3
• Consider baseline labs on an individual basis only, particularly if assessing renal function for dose adjustment 3
• This contrasts sharply with biologics and other systemic agents that require regular monitoring 3

Common Pitfalls to Avoid

• Do not wait for a "washout period" between stopping golimumab and starting apremilast—there is no evidence supporting this practice, and it leaves the patient without treatment 1
• Do not skip the 5-day titration schedule in an attempt to reach therapeutic dosing faster, as this significantly increases GI side effects 1, 2
• Do not order routine labs "just to be safe"—this adds unnecessary cost and patient burden without clinical benefit 3
• Be aware that apremilast has slower onset and lower likelihood of complete clearance compared to biologics, so set appropriate patient expectations 1

Drug Interaction Considerations

• Review the patient's medication list for strong CYP450 inducers (rifampin, phenobarbital, carbamazepine, phenytoin), as these may decrease apremilast efficacy and are not recommended for concurrent use 1
• No dangerous drug interactions have been reported with apremilast, but periodic medication review is prudent 1

Clinical Context

• Apremilast is generally less effective than biologics like golimumab, so this switch should be made for specific reasons such as patient preference for oral therapy, contraindications to biologics, or access/cost issues 1, 4
• The American College of Rheumatology guidelines suggest that switching from a biologic to apremilast may be considered if the patient has intolerable side effects with the current therapy or prefers oral versus parenteral administration 1
• Patients should understand they are trading the convenience of oral therapy and lack of monitoring for potentially reduced efficacy 1